DEPARTMENT OF LABOR AND ECONOMIC OPPORTUNITY  
DIRECTOR’S OFFICE  
IONIZING RADIATION RULES GOVERNING THE USE OF RADIATION  
MACHINES  
(By authority conferred on the director of the department of labor and economic  
opportunity by sections 13515, 13521, 13522, and 13527 of the public health code, 1978  
PA 368, MCL 333.13515, 333.13521, 333.13522, and 333.13527, and Executive  
Reorganization Order Nos. 1996-1, 1996-2, 2003-1, 2011-4, and 2019-3, MCL 330.3101,  
445.2001, 445.2011, 445.2030, and 125.1998)  
PART 1. GENERAL PROVISIONS FOR THE USE OF RADIATION  
MACHINES  
R 333.5001 Scope.  
Rule 1. (1) Except as otherwise specified, these rules apply to a person who acquires,  
receives, owns, possesses, uses, stores, or transfers a radiation machine.  
(2) Terms used in these rules shall have the same meaning as defined in the act.  
History: 2016 AACS.  
R 333.5002 Definitions; A.  
Rule 2. (1) "Absorbed dose" means the energy imparted by ionizing radiation per  
unit mass of irradiated material. The units of absorbed dose are the gray (Gy) and the  
rad.  
(2) "Accelerator" means a machine capable of accelerating electrons, protons,  
deuterons, or other charged particles in a vacuum and of discharging the resultant  
particulate or other radiation into a medium at energies usually in excess of 1  
megaelectron volt (MeV).  
(3) "Act" means 1978 PA 368, MCL 333.1101 to 333.25211. The terms defined in  
the act have the same meanings when used in these rules.  
(4) "Annual" means a period of 12 consecutive months.  
(5) "As low as reasonably achievable" (ALARA) means making every reasonable  
effort to maintain exposures to radiation as far below the dose limits in these rules as is  
practical, consistent with the purpose for which the registered activity is undertaken,  
taking into account the state of technology, the economics of improvements in relation to  
state of technology, the economics of improvements in relation to benefits to the public  
health and safety, and other societal and socioeconomic considerations, and in relation to  
utilization of registered radiation machines in the public interest.  
History: 2016 AACS.  
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R 333.5003 Definitions; C.  
Rule 3. (1) "Calendar quarter" means not less than 12 consecutive weeks nor more  
than 14 consecutive weeks. The first calendar quarter of each year shall begin in January  
and subsequent calendar quarters shall be so arranged such that no day is included in  
more than 1 calendar quarter and no day in any 1 year is omitted from inclusion within a  
calendar quarter. The method observed by the registrant for determining calendar  
quarters shall only be changed at the beginning of a year.  
(2) "Calibration" means the determination of either of the following:  
(a) The response or reading of an instrument relative to a series of known radiation  
values over the range of the instrument.  
(b) The strength of a source of radiation relative to a standard.  
(3) "Collective dose" means the sum of the individual doses received in a given  
period of time by a specified population from exposure to a specified source of radiation.  
(4) "Controlled area" means an area, outside of a restricted area but inside the site  
boundary, access to which can be limited by the registrant for any reason.  
History: 2016 AACS.  
R 333.5004 Definitions; D.  
Rule 4. (1) "Deep dose equivalent" (Hd), which applies to external whole body  
exposure, means the dose equivalent at a tissue depth of 1 centimeter (1000 mg/cm2).  
(2) "Department" means the department of licensing and regulatory affairs.  
(3) "Dose" or “radiation dose” means absorbed dose, dose equivalent, or effective  
dose equivalent as appropriate.  
(4) "Dose equivalent (HT)" means the product of the absorbed dose in tissue, quality  
factor, and all other necessary modifying factors at the location of interest. The units of  
dose equivalent are the sievert (Sv) and rem.  
(5) "Dose limits" or "limits" means the permissible upper bounds of radiation doses  
established under these rules.  
History: 2016 AACS.  
R 333.5005 Definitions; E.  
Rule 5. (1) "Effective dose equivalent (HE)" means the sum of the products of the  
dose equivalent to the organ or tissue (HT) and the weighting factor (WT) applicable to  
each of the body organs or tissues that are irradiated (HE = WTHT).  
(2) "Embryo or fetus" means the developing human organism from conception until  
the time of birth.  
(3) "Entrance or access point" means a location through which an individual could  
gain access to radiation areas. This includes entry or exit portals of sufficient size to  
permit human entry, irrespective of their intended use.  
(4) "Exposure" means being exposed to ionizing radiation.  
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(5) "External dose" means that portion of the dose equivalent received from a source  
of radiation outside the body.  
(6) "Extremity" means hand, elbow, and arm below the elbow, foot, knee, and leg  
below the knee.  
(7) "Extremity radiography" means radiography of the hand or arm excluding the  
shaft of the humerus or the foot or leg excluding the shaft of the femur.  
History: 2016 AACS.  
R 333.5006 Definitions; H.  
Rule 6. (1) "High radiation area" means an area, accessible to individuals, in which  
radiation levels from radiation sources external to the body could result in an individual  
receiving a dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from  
a source of radiation or 30 centimeters from any surface that the radiation penetrates.  
(2) "Human use" means the internal or external administration of radiation to human  
beings.  
History: 2016 AACS.  
R 333.5007 Definitions; I.  
Rule 7. (1) "Individual" means a human being.  
(2) "Individual monitoring" means the assessment of dose equivalent by the use of  
individual monitoring devices or by the use of survey data.  
(3) "Individual monitoring device" means a device designed to be worn by a single  
individual for the assessment of dose equivalent.  
Film badges, thermoluminescence  
dosimeters (TLDs), pocket ionization chambers, and optically stimulated luminescence  
(OSL) dosimeters are examples of individual monitoring devices.  
(4) "Inspection" means an official examination or observation including, but not  
limited to, tests, surveys, and monitoring to determine compliance with the act, these  
rules, registration conditions or orders of the department.  
(5) "Interlock" means a device arranged or connected such that the occurrence of an  
event or condition is required before a second event or condition can occur or continue to  
occur.  
History: 2016 AACS.  
R 333.5008 Definitions; L to O.  
Rule 8. (1) "Lens dose equivalent (LDE)" means the external exposure to the lens of  
the eye as the dose equivalent at a tissue depth of 0.3 centimeter (300 mg/cm2).  
(2) "Member of the public" means an individual except when that individual is  
receiving an occupational dose.  
(3) "Occupational dose" means the dose received by an individual in the course of  
employment in which the individual's assigned duties for the registrant involve exposure  
to sources of radiation, whether in the possession of the registrant or other person.  
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History: 2016 AACS.  
R 333.5009 Definitions; P and Q.  
Rule 9. (1) "Physician" means an individual licensed under section 17011 or 17511  
of article 15 of the public health code, 1978 PA 306, MCL 333.17011 and 333.17511 to  
practice medicine or osteopathic medicine.  
(2) "Protective apron" means an apron made of radiation-attenuating materials used  
to reduce exposure to radiation.  
(3) "Public dose" means the dose received by a member of the public from exposure  
to a radiation machine under the control of the registrant. Public dose does not include  
occupational dose, or doses received from a medical administration the individual has  
received, or from voluntary participation in medical research programs.  
(4) "Quality factor" (Q) means the modifying factor, listed in tables 20-1 and 20-2,  
that is used to derive dose equivalent from absorbed dose.  
History: 2016 AACS.  
R 333.5010 Definitions; R.  
Rule 10. (1) "Radiation" means ionizing radiation. Radiation, as used in these rules,  
does not include non-ionizing radiation, such as radiowaves or microwaves, visible,  
infrared, or ultraviolet light.  
(2) "Radiation area" means an area, accessible to individuals, in which radiation  
levels could result in an individual receiving a dose equivalent in excess of 0.05 mSv (5  
mrem) in 1 hour at 30 centimeters from the source of radiation or from any surface that  
the radiation penetrates.  
(3) "Radiation machine" means a machine that emits ionizing radiation when  
energized.  
(4) "Radiation protection supervisor" means the individual specified by the registrant  
who has the knowledge, authority, and responsibility for radiation protection.  
(5) "Registrant" means a person who is registered with the department and is legally  
obligated to register with the department pursuant to these rules and the act.  
(6) "Registration" for the purpose of these rules means registration of a radiation  
machine in writing with the department.  
(7) "Research and development" means 1 of the following:  
(a) Theoretical analysis, exploration, or experimentation.  
(b) The extension of investigative findings and theories of a scientific or technical  
nature into practical application for experimental and demonstration purposes, including  
the experimental production and testing of models, devices, equipment, materials, and  
processes. Research and development does not include the internal or external  
administration of radiation to human beings.  
(8) "Restricted area" means an area, access to which is limited by the registrant, for  
the purpose of protecting individuals against undue risks from exposure to sources of  
radiation. Restricted area does not include areas used as residential quarters, but separate  
rooms in a residential building may be set apart as a restricted area.  
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(9)  
"Roentgen" means the special unit of exposure.  
One roentgen (R)  
equals 2.58 x 10-4 coulombs per kilogram of air.  
History: 2016 AACS.  
R 333.5011 Definitions; S.  
Rule 11. (1) "Shallow dose equivalent" (Hs), which applies to the external exposure  
of the skin or an extremity, means the dose equivalent at a tissue depth of 0.007  
centimeter (7 mg/cm2) averaged over an area of 1 square centimeter.  
(2) “SI” means the abbreviation for the international system of units.  
(3) "Stochastic effect" means a health effect that occurs randomly and for which the  
probability of the effect occurring, rather than its severity, is assumed to be a linear  
function of dose without threshold. Hereditary effects and cancer incidence are examples  
of stochastic effects.  
(4) "Survey" means an evaluation of the radiological conditions and potential hazards  
incident to the use of radiation machines. When appropriate, this evaluation includes, but  
is not limited to, tests, physical examinations, and measurements of levels of radiation.  
History: 2016 AACS.  
R 333.5012 Definitions; T to V.  
Rule 12. (1) “Traceable to a national standard” means an instrument is calibrated at  
either the national institute of standards and technology (NIST) or at a calibration  
laboratory that participates in a proficiency program with the NIST at least once every 2  
years and the results of the proficiency test conducted within 24 months of calibration  
show agreement within 3% of the national standard in the appropriate energy range.  
(2) "Unrestricted area" or “uncontrolled area” means an area, access to which is  
neither limited nor controlled by the registrant for purposes of protection of individuals  
from exposure to radiation, or an area used for residential quarters.  
(3) "Very high radiation area" means an area, accessible to individuals, in which  
radiation levels from a radiation machine could result in an individual receiving an  
absorbed dose in excess of 5 Gy (500 rads) in 1 hour at 1 meter from a radiation machine  
or 1 meter from any surface that the radiation penetrates.  
History: 2016 AACS.  
R 333.5013 Definitions; W to Y.  
Rule 13. (1) "Week" means 7 consecutive days starting on Sunday.  
(2) "Weighting factor" wT for an organ or tissue (T) means the proportion of the risk  
of stochastic effects resulting from irradiation of that organ or tissue to the total risk of  
stochastic effects when the whole body is irradiated uniformly. For calculating the  
effective dose equivalent, the values of wT are as follows:  
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ORGAN DOSE WEIGHTING FACTORS  
Organ or Tissue  
Gonads  
wT  
0.2  
5
5
2
2
3
3
0
0
Breast  
0.1  
0.1  
0.1  
0.0  
0.0  
0.3  
1.0  
Red bone marrow  
Lung  
Thyroid  
Bone surfaces  
Remainder  
Whole Body  
(3) "Whole body" means, for purposes of external exposure, head, trunk including  
male gonads, arms above the elbow, or legs above the knee.  
(4) "Worker" means an individual engaged in activities under a registration issued by  
the department and controlled by a registrant, but does not include the registrant.  
(5) "Year" means the period of time beginning in January used to determine  
compliance with the provisions of these rules. The registrant may change the starting  
date of the year used to determine compliance by the registrant if the change is made at  
the beginning of the year. If a registrant changes in a year, the registrant shall assure that  
no day is omitted or duplicated in consecutive years.  
History: 2016 AACS.  
EXEMPTIONS  
R 333.5015 Exemptions.  
Rule 15. The department may, in response to a request or on its own initiative, grant  
an exemption or exception from the requirements of these rules as it determines is  
authorized by law and shall not result in an undue hazard to public health and safety,  
property, or the environment.  
History: 2016 AACS.  
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GENERAL REQUIREMENTS  
R 333.5017 Records.  
Rule 17. A registrant shall comply with all record requirements of these rules  
including, but not limited to, the use, storage, transfer, and disposal of each radiation  
machine.  
History: 2016 AACS.  
R 333.5018 Inspections.  
Rule 18. (1) Under the authority of MCL 333.13517(1), the department may enter at  
all reasonable times upon private or public property to conduct compliance  
investigations.  
(2) Under the authority of MCL 333.13517(2), the department may obtain a warrant  
if necessary for search of property or seizure of sources of radiation or evidence of a  
violation of the act or any rule or license.  
(3) A registrant shall make available to the department for inspection, all records  
maintained pursuant to these rules.  
History: 2016 AACS.  
R 333.5019 Tests.  
Rule 19. (1) A registrant shall make or cause to be made, tests that the department  
considers appropriate or necessary including, but not limited to, tests of the following:  
(a) The radiation machine.  
(b) Facilities where a radiation machine is used.  
(c) Radiation detection and monitoring instruments.  
(d) Other equipment and devices used in connection with the use of a radiation  
machine.  
(2) The registrant shall allow the department to perform tests that it considers  
appropriate to determine compliance with these rules.  
History: 2016 AACS.  
R 333.5020 Units of dose.  
Rule 20. (1) As used in these rules, the units of dose are the following:  
(a) Gray (Gy) is the SI unit of absorbed dose. One gray is equal to an absorbed dose  
of 1 joule per kilogram (100 rads).  
(b) Rad is the special unit of absorbed dose. One rad is equal to an absorbed dose of  
100 erg per gram or 0.01 joule per kilogram. (0.01 Gy)  
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(c) Sievert (Sv) is the SI unit of any of the quantities expressed as dose equivalent.  
The dose equivalent in sievert is equal to the absorbed dose in gray multiplied by the  
quality factor. (1 Sv = 100 rem)  
(d) Rem is the special unit of any of the quantities expressed as dose equivalent. The  
dose equivalent in rem is equal to the absorbed dose in rads multiplied by the quality  
factor. (1 rem = 0.01 Sv)  
(2) As used in these rules, the quality factors for converting absorbed dose to dose  
equivalent are shown in table 20-1:  
TABLE 20-1  
QUALITY FACTORS AND ABSORBED DOSE EQUIVALENCIES  
Type of Radiation  
Quality Factor  
Absorbed Dose  
Equal to a Unit  
Dose Equivalent  
1
*
X, gamma, or beta radiation and high-  
speed electrons  
1
Alpha  
particles,  
multiple-charged  
20  
0.05  
particles, fission fragments and heavy  
particles of unknown charge  
Neutrons of unknown energy  
High-energy protons  
10  
10  
0.1  
0.1  
*Absorbed dose in gray equal to 1 Sv or the absorbed dose in rad equal to 1 rem.  
(3) If it is more convenient to measure the neutron fluence rate than to determine the  
neutron dose equivalent rate in sievert per hour or rem per hour, as provided in subrule  
(2) of this rule, 0.01 Sv (1 rem) of neutron radiation of unknown energies may, for  
purposes of these rules, be assumed to result from a total fluence of 25 million neutrons  
per square centimeter incident upon the body. If sufficient information exists to estimate  
the approximate energy distribution of the neutrons, the registrant may use the fluence  
rate per unit dose equivalent or the appropriate quality factor from table 20-2 to convert a  
measured tissue dose in gray or rad to dose equivalent in sievert or rem.  
TABLE 20-2  
MEAN QUALITY FACTORS AND FLUENCE PER UNIT DOSE  
EQUIVALENT FOR MONOENERGETIC NEUTRONS  
Neutron  
Energy  
Quality  
Factor*  
Fluence per Unit  
Dose Equivalent**  
Fluence per Unit  
Dose Equivalent**  
(MeV)  
(Neutrons cm-2 Sv-  
(Neutrons cm-2 rem-  
1
1
)
)
(therma  
2.5 x 10-8  
2.0  
9.8 x 1010  
9.8 x 108  
l)  
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1.0 x 10-7  
1.0 x 10-6  
1.0 x 10-5  
1.0 x 10-4  
1.0 x 10-3  
1.0 x 10-2  
1.0 x 10-1  
5.0 x 10-1  
1.0  
2.0  
2.0  
2.0  
2.0  
2.0  
2.5  
7.5  
11.0  
11.0  
9.0  
8.0  
7.0  
6.5  
7.5  
8.0  
7.0  
5.5  
4.0  
3.5  
3.5  
3.5  
9.8 x 1010  
8.1 x 1010  
8.1 x 1010  
8.4 x 1010  
9.8 x 1010  
1.0 x 1011  
1.7 x 1010  
3.9 x 109  
2.7 x 109  
2.9 x 109  
2.3 x 109  
2.4 x 109  
2.4 x 109  
1.7 x 109  
1.6 x 109  
1.4 x 109  
1.6 x 109  
2.0 x 109  
1.9 x 109  
1.6 x 109  
1.4 x 109  
9.8 x 108  
8.1 x 108  
8.1 x 108  
8.4 x 108  
9.8 x 108  
1.0 x 109  
1.7 x 108  
3.9 x 107  
2.7 x 107  
2.9 x 107  
2.3 x 107  
2.4 x 107  
2.4 x 107  
1.7 x 107  
1.6 x 107  
1.4 x 107  
1.6 x 107  
2.0 x 107  
1.9 x 107  
1.6 x 107  
1.4 x 107  
2.5  
5.0  
7.0  
1.0 x 101  
1.4 x 101  
2.0 x 101  
4.0 x 101  
6.0 x 101  
1.0 x 102  
2.0 x 102  
3.0 x 102  
4.0 x 102  
*Value of quality factor at the point where the dose equivalent is maximum in a 30-centimeter  
diameter cylinder tissue-equivalent phantom.  
**Monoenergetic neutrons incident normally on a 30-centimeter diameter cylinder tissue-  
equivalent phantom.  
History: 2016 AACS.  
R 333.5021 Additional requirements.  
Rule 21. The department may impose additional requirements on a registrant in  
accordance with the act, 1978 PA 368, MCL 333.1011 to 333.25211, by rule, order, or  
registration conditions that it considers appropriate or necessary to minimize danger to  
public health and safety, property, and the environment.  
History: 2016 AACS.  
ENFORCEMENT REQUIREMENTS  
R 333.5023 Violations.  
Rule 23. (1) Under authority of MCL 333.13536, the department may obtain an  
injunction or other court order prohibiting a violation of the act, a rule, an order, or a  
registration condition issued under the act.  
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(2) Under the authority of MCL 333.2262, the department, in addition to taking other  
enforcement action, may impose a civil penalty, not to exceed $1,000 for each violation,  
on a person who violates the act, a rule, an order, or a registration condition issued under  
the act. Each day that a violation continues shall constitute a separate violation.  
(3) A person who violates the act, a rule, an order, or a registration condition issued  
under the act may be guilty of a misdemeanor and, on conviction, may be fined,  
imprisoned, or both, as provided by law.  
History: 2016 AACS.  
R 333.5024 Emergency orders and impounding.  
Rule 24. (1) The department may issue an emergency order pursuant to MCL  
333.13516. A person responsible for the radiation machine shall bear expenses incidental  
to the order.  
(2)  
A radiation machine shall be subject to impoundment pursuant to  
MCL 333.13517. Impoundment by the department shall not relieve the owner of the  
responsibility for the radiation machine. A person who has a radiation machine  
impounded shall bear expenses incidental to the impoundment.  
History: 2016 AACS.  
HEARING PROCEDURE  
R 333.5026 Hearing procedure.  
Rule 26. (1) Before the issuance of an order, the department shall afford an  
opportunity for a hearing that shall be conducted pursuant to the administrative  
procedures act of 1969 PA 306, MCL 24.201 to MCL 24.328.  
(2) In a contested case, the department shall conduct a hearing as provided in the  
administrative procedures act of 1969 PA 306, MCL 24.201 to MCL 24.328.  
History: 2016 AACS.  
PART 2. REGISTRATION OF RADIATION MACHINES  
R 333.5031 Purpose and scope.  
Rule 31. (1) This part provides for the registration of radiation machines, including  
particle accelerators, whether used primarily for x-ray production or other purposes.  
(2) In addition to the requirements of this part, all registrants are subject to the  
applicable provisions of other parts of these rules.  
History: 2016 AACS.  
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R 333.5032 Definition.  
Rule 32. As used in this part, “facility” means the location, building, vehicle, or  
complex under 1 administrative control, where 1 or more radiation machines are installed  
or located.  
History: 2016 AACS.  
R 333.5033 Exemptions.  
Rule 33. (1) Unless specifically covered elsewhere in these rules, electronic  
equipment that produces radiation incidental to its operation for other purposes is exempt  
from the registration and notification requirements of this part if the dose equivalent rate  
averaged over an area of 10 square centimeters does not exceed 5 microsieverts (0.5  
mrem) per hour at 5 centimeters from any accessible surface of the equipment. The  
production, testing, or factory servicing of the equipment shall not be exempt.  
(2) Radiation machines that are electrically disconnected pending sale, transfer of  
ownership, or destructive disposal or that are made inoperable are exempt from the  
requirements of this part. An inoperable radiation machine is one that cannot be  
energized when connected to a power supply without repair or modification.  
(3) Domestic television receivers and video display monitors are exempt from the  
requirements of this part.  
(4) Electron microscopes are exempt from this part if the instrument is not capable of  
exceeding an operating potential of 50 kilovolts.  
History: 2016 AACS.  
R 333.5034 Responsibility for compliance with rules.  
Rule 34. The owner or registrant, the person effectively in control of radiation  
machines not exempt under R 333.5033, and the individual who, pursuant to R 333.5037,  
is designated as the radiation protection supervisor shall be responsible for full  
compliance with all provisions of these rules.  
History: 2016 AACS.  
R 333.5036 Shielding plan review.  
Rule 36. (1) An applicant, before registration, shall submit the floor plans, shielding  
specifications, and equipment arrangement of all new installations, or modifications of  
existing installations, using a radiation machine, to the department for review and  
approval. Application for a radiation shielding plan review shall be completed on an  
application form supplied by the department according to the instructions contained in  
that form. Radiation shielding plans are not required to be submitted for any of the  
following:  
(a) Dental intraoral or panoramic machines used in dental clinical facilities.  
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(b) Cabinet x-ray systems, analytical systems, process or control gauges, or cold-  
cathode gas discharge tubes.  
(c) Bone densitometers.  
(d) Mobile or portable radiographic machines unless routinely used in 1 location.  
(e) C-arm fluoroscopic systems having a maximum source-image receptor distance  
of less than 45 centimeters that are used for extremity use only.  
(2) The department may require the applicant to use the services of a health physicist  
or medical physicist to determine the shielding requirements before the department’s plan  
review and approval.  
(3) The department’s approval of a plan shall not preclude the requirement of  
additional modifications if a subsequent analysis shows an individual could receive a  
dose exceeding the limits in R 333.5057 to R 333.5060.  
(4) Shielding design goals of 0.1 millisievert (10 mrem) per week for controlled  
areas and 0.02 millisievert (2 mrem) per week and 0.02 millisievert (2 mrem) in any 1  
hour for uncontrolled areas shall be applied to new facilities and to new construction in  
existing facilities.  
(a) For the purpose of this subrule, “controlled area” means a limited access area  
where the occupational exposure of personnel to radiation is under the supervision of an  
individual in charge of radiation protection. In a controlled area, the access, occupancy,  
and working conditions are controlled for the purpose of radiation protection.  
(b) For the purpose of this subrule, “uncontrolled area” means all areas of the facility  
and the surrounding environs that are not controlled for the purpose of radiation  
protection.  
(5) For machines installed after the effective date of this part, the registrant shall  
maintain for inspection by the department a scale drawing of the room where a stationary  
radiation machine system is located. The drawing or accompanying attachments shall  
indicate the use of areas adjacent to the room and include an estimate of the occupancy in  
each area. In addition, the drawing or attachment shall include at least 1 of the following:  
(a) The type and thickness of materials, or lead equivalency, of each protective  
barrier.  
(b) The results of a survey for radiation levels at the operator's position and at  
pertinent points outside the room under specified test conditions.  
(6) The department may withhold initial registration of a radiation machine pending  
receipt of either of the following:  
(a) Plans and specifications for room design and shielding and approval of those  
plans and specifications.  
(b) Documentation from the applicant that a certificate of need (CON) has been  
issued if the use of that machine is a covered clinical service as defined in the act.  
History: 2016 AACS.  
R 333.5037 Registration of radiation machines.  
Rule 37. (1) A person with 1 or more radiation machines shall do both of the  
following:  
(a) Apply for registration of each radiation machine with the department before  
operating the machine. Application for registration shall be completed on forms provided  
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by the department and shall contain all the information required by the form and  
associated instructions. The appropriate registration fee specified in R 333.5043 shall be  
submitted with the application.  
(b) Designate, on the application form, a radiation protection supervisor to be  
responsible for radiation protection and ensure that the individual meets all of the  
following:  
(i) Has completed a radiation safety officer training course, completed educational  
courses related to ionizing radiation safety, or has experience in the use and familiarity  
with the type of equipment used.  
(ii) Is knowledgeable about the hazards and precautions in the handling of the  
radiation machines for which this individual is responsible.  
(iii) Has read and understands the applicable requirements of these rules.  
(iv) Authorizes operation of radiation machines only by individuals who have  
received instructions in their safe use. These instructions shall include, but are not  
limited to, the proper use of individual monitoring devices, the registrant’s operating and  
safety procedures, and all other applicable rules governing the use of the radiation  
machine that the individual will be operating.  
(v) Has the authority to make or cause to be made radiation surveys and other  
procedures as may be necessary to demonstrate compliance with these rules.  
(vi) Has the authority to make or cause to be made changes as may be necessary to  
comply with these rules.  
(2) A person that registers 1 or more radiation machines will be issued a department  
facility registration number.  
History: 2016 AACS.  
R 333.5038 Machine registration tags.  
Rule 38. (1) The department shall issue a registration tag for each radiation machine  
when it is properly registered with the department. The tag shall include a registration  
number uniquely assigned to that specific machine.  
(2) The registrant shall apply the registration tag in a visible location on the control  
panel of the specified radiation machine. If applying the registration tag to the control  
panel is not practical, the registrant shall place the tag in another visible location on a  
component of the machine not likely to be replaced.  
(3) The registrant shall not authorize removal of the registration tag from the  
radiation machine unless instructed by the department. If the tag is removed or defaced,  
the registrant shall notify the department and request a replacement tag. The request shall  
specify the tag number and machine description from the certificate of registration.  
History: 2016 AACS.  
R 333.5039 Certificates of registration.  
Rule 39. (1) The department shall issue a certificate of registration if it determines  
that an application meets the requirements of this part.  
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(2) The department may incorporate in the certificate of registration additional  
requirements in the form of registration conditions regarding the registrant's receipt,  
possession, and use of a radiation machine as it considers appropriate or necessary. The  
registrant shall comply with all registration conditions.  
(3) The certificate of registration shall list all radiation machines registered at a  
facility.  
History: 2016 AACS.  
R 333.5040 Expiration of registration.  
Rule 40. Except as provided by R 333.5041(2), a registration shall expire at the end  
of the specified day in the month and year stated in the certificate of registration.  
History: 2016 AACS.  
R 333.5041 Renewal of registration.  
Rule 41. (1) The registrant shall annually file an application to renew the registration  
pursuant to R 333.5037 and shall submit the appropriate registration fee as specified in R  
333.5043 with the application.  
(2) If a registrant has filed an application to renew the registration in proper form not  
less than 30 days before the expiration of the existing registration, the existing  
registration shall not expire until the application status is determined by the department.  
History: 2016 AACS.  
R 333.5042 Notice of change.  
Rule 42. (1) The registrant shall notify the department in writing before making a  
change that would render the information contained in the application for registration, the  
certificate of registration, or both, no longer accurate. When a radiation machine is sold,  
transferred, or disposed, the notification shall specify the proposed recipient of the  
machine, or the location and method of disposal.  
(2) A complete change in ownership, possession, or location of all machines listed on  
a certificate of registration terminates the certificate of record and shall require a new  
application for registration except as provided in subrule (4) of this rule.  
(3) If there is a partial change, the department may terminate the certificate of  
registration of record and issue a new certificate pursuant to R 333.5039.  
(4) Notwithstanding subrule (2) of this rule, replacement of all machines listed on a  
certificate of registration shall be considered a partial change if the name and address of  
the registrant and the name and address of the facility are not changed.  
History: 2016 AACS.  
R 333.5043 Fees.  
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Rule 43. (1) Pursuant to section 13522 of the act, MCL 333.13522, fees for  
registration of radiation machines, fees for follow-up inspections due to noncompliance,  
fees for mammography machine inspections, and fees assessed in connection with  
mammography authorization shall be adjusted annually by an amount determined by the  
state treasurer to reflect the cumulative annual percentage change in the Detroit consumer  
price index, not to exceed 5%. As used in this part, “Detroit consumer price index”  
means the most comprehensive index of consumer prices available for the Detroit area  
from the bureau of labor statistics of the United States Department of Labor.  
(2) A total or partial refund of a registration fee shall not be made due to a notice of  
change resulting in the deletion of tubes or machines, or in the termination of the  
radiation machine registration certificate before the expiration date of the registration.  
(3) Specific registration fees depend on the number of x-ray tubes included in the  
application for registration or renewal of registration. Current radiation machine  
registration fees are posted on the website of the department.  
History: 2016 AACS.  
R 333.5045 Approval not implied.  
Rule 45. A person, in an advertisement, shall not refer to the fact that a facility is  
registered with the department pursuant to this part. A person shall not state or imply that  
the department has approved an activity under a registration.  
History: 2016 AACS.  
R 333.5046 Vendor obligation; notification of transfer; duty to report.  
Rule 46. (1) A person who sells, leases, transfers, lends, disposes, assembles, or  
installs a radiation machine in this state shall notify the department in writing, within 15  
days after the end of the calendar quarter, all of the following:  
(a) The name and address of the person who has received the machine.  
(b) The manufacturer, model, type, and number of x-ray tubes of each radiation  
machine transferred.  
(c) The date of transfer of each radiation machine.  
(d) The department facility registration number and machine registration tag number,  
if the facility is registered or if the machine was previously registered with the  
department.  
(e) If a diagnostic x-ray system contains certified components, a copy of the  
assembler's report, prepared in compliance with the federal performance standards for  
ionizing radiation products, 21 C.F.R. 1020.30(d) (June 2006), shall be submitted in place  
of subdivisions (a) to (c) of this subrule.  
(2) A person shall not make, sell, lease, transfer, lend, assemble, or install a radiation  
machine or the supplies used with a machine, unless the supplies and equipment, when  
properly placed in operation and used, meet the requirements of these rules.  
History: 2016 AACS.  
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R 333.5047 Out-of-state radiation machines.  
Rule 47. (1) If a person brings a radiation machine into the state for any use, that  
person shall register the machine with the department, comply with all applicable rules of  
the department, and supply the department with other information as the department may  
request.  
(2) If a person plans to bring a radiation machine into the state for temporary use,  
that person shall provide written notice to the department not less than 3 working days  
before the machine is to be used in the state. The notice shall include all of the  
following:  
(a) The facility registration number.  
(b) The machine registration number.  
(c) The nature, duration, and scope of use.  
(d) The exact location or locations where the radiation machine will be used.  
(e) Documentation that radiation shielding plan review information was submitted  
pursuant to R 333.5036.  
(3) If, for a specific situation, the 3 working-day period would impose an undue  
hardship on the person, the department may grant permission to proceed sooner.  
History: 2016 AACS.  
PART 3. STANDARDS FOR PROTECTION AGAINST RADIATION FOR  
USERS OF RADIATION MACHINES  
GENERAL PROVISIONS  
R 333.5051 Purpose.  
Rule 51. (1) This part establishes standards for protection against ionizing radiation  
resulting from activities conducted under registrations of radiation machines issued by  
the department.  
(2) The requirements of this part are designed to control the receipt, possession, use,  
and transfer of radiation machines by a registrant so that the total dose to an individual,  
including doses resulting from all radiation machines, does not exceed the standards for  
protection against radiation prescribed in this part. Nothing in this part shall be construed  
as limiting actions that may be necessary to protect health and safety.  
History: 2016 AACS.  
R 333.5052 Scope.  
Rule 52. This part applies to radiation machine registrants of the department. The  
limits in this part do not apply to doses due to background radiation, exposure of patients  
to radiation for medical diagnosis or therapy, exposure from individuals administered  
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radioactive material, or exposure from voluntary participation in medical research  
programs.  
History: 2016 AACS.  
R 333.5053 Definitions.  
Rule 53. As used in these rules, the following definitions apply:  
(a) "Declared pregnant woman" means a woman who has voluntarily informed the  
registrant, in writing, of her pregnancy and the estimated date of conception. The  
declaration remains in effect until the declared pregnant woman withdraws the  
declaration in writing or is no longer pregnant.  
(b) "Dosimetry processor" means an individual or an organization that processes and  
evaluates individual monitoring equipment to determine the radiation dose delivered to  
the monitoring equipment.  
History: 2016 AACS.  
R 333.5055. Intentional exposure of humans.  
Rule 55. (1) Nothing in these rules shall be construed as limiting the intentional  
exposure of patients to radiation for the purpose of medical diagnosis, medical therapy, or  
medical research conducted by a health practitioner licensed under article 15 of the act.  
(2) Intentional exposure of individuals to radiation for diagnostic or therapeutic  
purposes shall be limited to supervision or prescriptions by a person licensed under  
article 15 of the act to provide such.  
(3) Nothing in these rules shall be construed as authorization to conduct medical  
diagnosis, medical therapy, or medical research that is not fully consistent with the  
standards of practice for a health practitioner licensed under article 15 of the act.  
History: 2016 AACS.  
OCCUPATIONAL DOSE LIMITS  
R 333.5057 Occupational dose limits for adults.  
Rule 57. (1) A registrant shall control the occupational dose to individual adults, to  
the following dose limits:  
(a) An annual limit, which is the more limiting of the following:  
(i) The effective dose equivalent of 0.05 sievert (5 rem).  
(ii) The dose equivalent to an individual organ or tissue other than the lens of the eye  
of 0.5 sievert (50 rem).  
(b) The annual limits to the lens of the eye, to the skin of the whole body, and to the  
skin of the extremities which are the following:  
(i) A lens dose equivalent of 0.15 sieverts (15 rem).  
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(ii) A shallow dose equivalent of 0.5 sievert (50 rem) to the skin of the whole body  
or to the skin of an extremity.  
(2) For exposure determined by measurement with an external individual monitoring  
device, the deep-dose equivalent shall be used in place of the effective dose equivalent,  
unless the effective dose equivalent is determined by a dosimetry method approved by  
the department.  
(3) The assigned deep dose equivalent shall be for the part of the body receiving the  
highest exposure. The assigned shallow-dose equivalent shall be the dose averaged over  
the contiguous 10 square centimeters of skin receiving the highest exposure.  
(a) If the individual monitoring device was not in the region of highest potential  
exposure or the results of individual monitoring are unavailable, the deep dose  
equivalent, lens dose equivalent, and shallow dose equivalent may be assessed from  
surveys or other radiation measurements to demonstrate compliance with the  
occupational dose limits.  
(b) When a protective apron is worn while working with medical fluoroscopic  
equipment and monitoring is conducted as specified in R 333.5065, the effective dose  
equivalent shall be determined by any of the following:  
(i) When only 1 individual monitoring device is used and it is located at the neck  
(collar) outside the protective apron, the reported deep dose equivalent shall be the  
effective dose equivalent for external radiation.  
(ii) When only 1 individual monitoring device is used and it is located at the neck  
outside the protective apron, and the reported dose exceeds 25% of the limit specified in  
subrule (1) of this rule, the reported deep dose equivalent value multiplied by 0.3 shall be  
the effective dose equivalent for external radiation.  
(iii) When 2 individual monitoring devices are worn, 1 under the protective apron at  
the waist and the other outside the protective apron at the neck, the effective dose  
equivalent for external radiation shall be assigned the value of the sum of the deep dose  
equivalent reported for the individual monitoring device located at the waist under the  
protective apron multiplied by 1.5 and the deep dose equivalent reported for the  
individual monitoring device located at the neck outside the protective apron multiplied  
by 0.04.  
(4) The registrant shall reduce the dose that an individual may be allowed to receive  
in the current year by the amount of occupational dose received while employed by  
another person during the current year. Requirements for determining prior occupational  
exposure are provided in R 333.5080.  
History: 2016 AACS.  
Editor's Note: An obvious error in R 325.5057 was corrected at the request of the promulgating  
agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL 24.256. The rule  
containing the error was published in Michigan Register, 2016 MR 10. The memorandum requesting the  
correction was published in Michigan Register, 2016 MR 16.  
R 333.5058 Occupational dose limits for minors.  
Rule 58. The annual occupational dose limits for a minor are 10% of the annual  
occupational dose limits specified for an adult worker in R 333.5057.  
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History: 2016 AACS.  
R 333.5059 Dose equivalent to embryo or fetus.  
Rule 59. (1) The registrant shall ensure that the dose equivalent to the embryo or  
fetus during the entire pregnancy, due to the occupational exposure of a declared  
pregnant woman, does not exceed 5 millisieverts (500 mrem). Records for doses to the  
embryo or fetus shall be kept according to R 333.5081(4).  
(2) The registrant shall make efforts to avoid substantial variation above a uniform  
monthly exposure rate to a declared pregnant woman to satisfy the limit in subrule (1) of  
this rule.  
(3) The dose equivalent to the embryo or fetus is the deep dose equivalent to the  
declared pregnant woman.  
(4) If the dose equivalent to the embryo or fetus has exceeded 4.5 millisieverts  
(450 mrem), when the woman declares the pregnancy to the registrant, the registrant shall  
be considered in compliance with subrule (1) of this rule if the additional dose equivalent  
to the embryo or fetus does not exceed 0.5 millisievert (50 mrem) during the remainder of  
the pregnancy.  
History: 2016 AACS.  
RADIATION DOSE LIMITS FOR INDIVIDUAL MEMBERS OF THE  
PUBLIC  
R 333.5060 Dose limits for individual members of the public.  
Rule 60. (1) A registrant shall conduct operations in compliance with both of the  
following:  
(a) The dose equivalent to a member of the public from the registered operation does  
not exceed 1 millisievert (100 mrem) in a year, excluding dose contributions from both of  
the following:  
(i) Medical administrations the individual has received.  
(ii) Voluntary participation in medical research programs.  
(b) The dose in an unrestricted area from radiation machines does not exceed 0.02  
millisievert (2 mrem) in any 1 hour.  
(2) If a registrant allows members of the public to have access to controlled areas, the  
dose limits for members of the public shall apply to those individuals.  
(3) The department may impose additional restrictions on radiation levels in  
unrestricted areas to restrict the collective dose.  
History: 2016 AACS.  
R 333.5061 Compliance with dose limits for individual members of the public.  
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Rule 61. A registrant shall make or cause to be made, as appropriate, surveys of  
radiation levels in unrestricted and controlled areas to demonstrate compliance with the  
dose limits for individual members of the public in R 333.5060.  
History: 2016 AACS.  
SURVEYS AND MONITORING  
R 333.5063 General.  
Rule 63. (1) A registrant shall make, or cause to be made, surveys that may be  
necessary to demonstrate compliance with the rules in this part and are reasonable under  
the circumstances to evaluate both of the following:  
(a) The magnitude and extent of radiation levels.  
(b) All potential radiological hazards.  
(2) A registrant shall ensure that instruments and equipment used for quantitative  
radiation measurements are calibrated annually for the radiation measured, except as  
otherwise specified in another part of these rules or in a registration condition.  
(3) This subrule applies to personnel dosimeters, including dosimeters used to  
measure the dose to an extremity, that require processing to determine the radiation dose  
and that a registrant uses to comply with R 333.5057, with other applicable provisions of  
these rules, or with conditions specified in a registration. This subrule does not apply to  
direct and indirect reading pocket dosimeters and electronic personnel dosimeters.  
Personnel dosimeters shall be processed and evaluated by a dosimetry processor that  
meets both of the following:  
(a) Holds a current personnel dosimetry accreditation from the national voluntary  
laboratory accreditation program of the national institute of standards and technology.  
(b) Is approved in this accreditation process for the type of radiation or radiations  
included in the national voluntary laboratory accreditation program that most closely  
approximates the type of radiation or radiations for which the individual wearing the  
dosimeter is monitored.  
History: 2016 AACS.  
R 333.5064 Conditions requiring individual monitoring of occupational dose.  
Rule 64. A registrant shall monitor occupational exposure to radiation from radiation  
machines under the control of the registrant and shall supply and require the use of  
individual monitoring devices by all of the following:  
(a) An adult likely to receive in 1 year a dose greater than 10 % of the limits  
specified in R 333.5057(1).  
(b) A minor likely to receive in 1 year a deep dose equivalent greater than 1  
millisievert (100 mrem), a lens dose equivalent greater than 1.5 millisieverts (150 mrem),  
or a shallow dose equivalent to the skin or to the extremities greater than 5 millisieverts  
(500 mrem).  
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(c) A declared pregnant woman likely to receive during the entire pregnancy a deep  
dose equivalent greater than 1 millisievert (100 mrem).  
(d) An individual who enters a high or very high radiation area.  
(e) An individual for whom personnel monitoring is required under other parts of  
these rules pertaining to specific uses of radiation machines.  
History: 2016 AACS.  
R 333.5065 Location of individual monitoring devices.  
Rule 65. If R 333.5064 or other parts of these rules require occupational dose  
monitoring for an individual, the registrant shall ensure that the individual wears an  
individual monitoring device or devices according to 1 of the following:  
(a) An individual monitoring device used for monitoring the dose to the whole  
body shall be worn at the unshielded location of the whole body likely to receive the  
highest exposure. When a protective apron is worn, the location of the individual  
monitoring device is typically at the neck as described in R 333.5057(3)(b)(i).  
(b) An individual monitoring device used to monitor the dose to an embryo or fetus  
of a declared pregnant woman, pursuant to R 333.5059(1), shall be worn at the waist  
under any protective apron being worn by the woman.  
(c) An individual monitoring device used for monitoring the lens dose equivalent,  
to demonstrate compliance with R 333.5057(1)(b)(i), shall be worn at the neck, outside  
any protective apron being worn by the monitored individual, or at an unshielded location  
closer to the eye.  
(d) An individual monitoring device used for monitoring the dose to the skin of the  
extremities, to demonstrate compliance with R 333.5057(1)(b)(ii), shall be worn on the  
extremity likely to receive the highest exposure. The individual monitoring device shall  
be oriented to measure the highest dose to the extremity being monitored.  
History: 2016 AACS; 2023 MR 11, Eff. June 16, 2023.  
CONTROL OF EXPOSURE IN RESTRICTED AREAS  
R 333.5067 Control of access to high radiation areas.  
Rule 67. (1) A registrant shall ensure that each entrance or access point to a high  
radiation area has 1 or more of the following control features:  
(a) A device that, upon entry into the area, causes the radiation level to be reduced  
below the level where an individual could receive a deep dose equivalent of 1 millisievert  
(100 mrem) in 1 hour at 30 centimeters from the source of radiation or from any surface  
that the radiation penetrates.  
(b) A device that energizes a conspicuous visible or audible alarm signal so that the  
individual entering the high radiation area and the supervisor of the activity are made  
aware of the entry.  
(c) Locked entryways, except when access to the area is required, with positive  
control over each individual entry.  
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(2) In place of the controls required for a high radiation area by subrule (1) of this  
rule, a registrant may substitute continuous direct or electronic surveillance that is  
capable of preventing unauthorized entry.  
(3) A registrant or applicant for a registration may apply to the department for  
approval of alternative methods for controlling access to high radiation areas.  
(4) A registrant shall establish the controls required by subrules (1) and (3) of this  
rule in a way that does not prevent individuals from leaving a high radiation area.  
(5) The registrant is not required to control entrance or access to rooms or other areas  
containing radiation machines capable of producing a high radiation area as described in  
subrule (1) of this rule if the registrant meets all the specific requirements for access and  
control specified in other applicable parts of these rules.  
History: 2016 AACS.  
R 333.5068 Control of access to very high radiation areas.  
Rule 68. (1) In addition to the requirements in R 333.5067, a registrant shall institute  
additional measures to ensure that an individual cannot gain unauthorized or inadvertent  
access to areas in which radiation levels could be encountered at 5 grays (500 rads) or  
more in 1 hour at 1 meter from a radiation machine or any surface through which the  
radiation penetrates. This requirement does not apply to rooms or areas in which  
diagnostic x-ray systems are the only source of radiation.  
(2) A registrant is not required to control entrance or access to rooms or other areas  
containing radiation machines capable of producing a very high radiation area as  
described in subrule (1) of this rule if the registrant meets all the specific requirements for  
access and control specified in other applicable parts of these rules.  
History: 2016 AACS.  
R 333.5069 Security and control of sources of radiation.  
Rule 69. A registrant shall use devices or administrative procedures, or both, to  
prevent unauthorized use or removal of radiation machines.  
History: 2016 AACS.  
PRECAUTIONARY PROCEDURES  
R 333.5071 Caution signs.  
Rule 71. (1) Except as otherwise authorized by the department, symbols prescribed  
by R 333.5072 shall use the conventional 3-bladed design as follows:  
RADIATION SYMBOL  
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1. Cross-hatched area is to be magenta or purple.  
2. Background is to be yellow.  
(2) In addition to the contents of signs and labels required in this part, a registrant  
may provide, on or near the required signs and labels, additional information to make  
individuals aware of potential radiation exposures and to minimize those exposures.  
History: 2016 AACS.  
R 333.5072 Posting requirements.  
Rule 72. (1) The registrant shall post each radiation area with a conspicuous sign or  
signs bearing the radiation symbol and the words “CAUTION, RADIATION AREA”.  
(2) The registrant shall post each high radiation area with a conspicuous sign or signs  
bearing the radiation symbol and the words “CAUTION, HIGH RADIATION AREA” or  
“DANGER, HIGH RADIATION AREA”.  
(3) The registrant shall post each very high radiation area with a conspicuous sign or  
signs bearing the radiation symbol and the words “GRAVE DANGER, VERY HIGH  
RADIATION AREA”.  
(4) The registrant shall post access openings to manufacturing or process equipment  
such as tanks and vessels on or in which radiation machines are mounted, if an individual  
can gain access to the radiation beam and receive a dose to any part of his or her body  
greater than the applicable limits for individuals in R 333.5057 to R 333.5061. The  
posting shall include a conspicuous sign or signs bearing the radiation symbol and  
warning of the hazard.  
History: 2016 AACS.  
R 333.5073 Exceptions to posting requirements.  
Rule 73. A registrant is not required to post caution signs pursuant to R 333.5072 in  
areas or rooms in any of the following situations:  
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(a) The radiation machines are in the room for periods of less than 8 hours and  
constantly attended by an individual who takes the precautions necessary to prevent the  
exposure of individuals to radiation above the limits specified in this part. The area or  
room shall be under the registrant’s control.  
(b) The room is used for teletherapy and access is controlled pursuant to the  
applicable radiation therapy rules. Attending personnel shall take the necessary  
precautions to prevent the inadvertent exposure of workers, other patients, and members  
of the public to radiation above the limits specified in this part.  
(c) The area or room contains radiation machines used for diagnosis by, or on behalf  
of, health practitioners licensed under article 15 of the act, MCL 333.1011 to 333.25211.  
History: 2016 AACS.  
R 333.5074 Labeling radiation machines.  
Rule 74. A registrant shall ensure that each radiation machine is labeled in a  
conspicuous manner that cautions individuals that radiation is produced when the  
machine is energized.  
History: 2016 AACS.  
R 333.5075 Use of safety equipment.  
Rule 75. (1) The requirements for safety interlocks, protective enclosures, protective  
clothing, precautionary labels, or other safety equipment presume the proper use of this  
equipment. Unauthorized override of safety interlocks or other intentional misuse or  
non-use of required safety equipment shall be considered willful violation of these rules.  
(2) Authorized override of safety interlocks shall be requested by the radiation  
protection supervisor in writing from the department. The request shall include  
justification, precautionary procedures during override, and statement of immediate  
supervision by the radiation protection supervisor or his or her authorized representative.  
Prior approval by the department is required. The approval may be granted by written  
condition on the registration certificate or by telephone followed by written confirmation  
from the department.  
History: 2016 AACS.  
RECORDS  
R 333.5077 General provisions for records.  
Rule 77. (1) A registrant shall use either the international system of units (SI) gray,  
sievert, and coulomb per kilogram, or the special units rad, rem, and roentgen, including  
multiples and subdivisions, and shall clearly indicate the units of all quantities on records  
required by this part.  
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(2) The registrant shall make a clear distinction among the quantities entered on the  
records required by these rules. The dose to an individual shall be specified in quantities  
such as the effective dose equivalent, shallow dose equivalent, lens dose equivalent, or  
deep dose equivalent.  
History: 2016 AACS.  
R 333.5079 Records of surveys and calibrations.  
Rule 79. (1) A registrant shall retain records of the results of surveys and calibrations  
required by R 333.5063 for 3 years after the record is made.  
(2) A registrant shall maintain records of the results of surveys used to determine  
exposures, in the absence of or in combination with individual monitoring data, in the  
assessment of individual dose equivalents. A registrant shall retain these records until the  
department terminates the registration requiring the record.  
History: 2016 AACS.  
R 333.5080 Determination and records of prior occupational dose.  
Rule 80. (1) For each individual likely to receive an annual occupational dose  
requiring monitoring under R 333.5064, the registrant shall determine the occupational  
radiation dose received during the current year. To comply, a registrant may do any of  
the following:  
(a) Accept, as a record of an individual’s occupational dose, a written and signed  
statement from the individual, or from the individual's most recent employer for work  
involving radiation exposure, that documents the nature and the amount of occupational  
dose the individual may have received during the current year.  
(b) Accept, as the record of cumulative radiation dose, an up-to-date department  
Form MIOSHA-RSS-101, or equivalent, signed by the individual and countersigned by  
either an appropriate official of the most recent employer for work involving radiation  
exposure, or by the individual's current employer if the individual is not employed by the  
registrant.  
(c) Obtain reports of the individual's dose equivalents from the most recent employer  
for work involving radiation exposure, or the individual's current employer if the  
individual is not employed by the registrant, by telephone, telegram, facsimile, other  
electronic media, or letter. The registrant shall request a written verification of the dose  
data if the authenticity of the reports cannot be established.  
(2) The registrant shall record the exposure history of each individual, as required by  
subrule (1) of this rule, on department Form MIOSHA-RSS-101, or other clear and  
legible record, that includes all the information required on that form. The form or record  
shall show each period in which the individual received occupational exposure to  
radiation. For each period for which the registrant obtains reports, the registrant shall use  
the dose shown in the report in preparing department Form MIOSHA-RSS-101 or  
equivalent. For a period in which the registrant does not obtain a report, the registrant  
shall place a notation on department Form MIOSHA-RSS-101, or equivalent, indicating  
the periods for which data are not available.  
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(3) If the registrant cannot obtain a complete record of an individual’s occupational  
dose for the current year, the registrant shall assume, in establishing administrative  
controls pursuant to R 333.5057(4) for the current year, that the allowable dose limit for  
the individual is reduced by 12.5 millisieverts (1,250 mrem) for each calendar quarter for  
which records are unavailable and the individual was engaged in activities that could  
have resulted in occupational radiation exposure.  
(4) The registrant shall retain the records on department Form MIOSHA-RSS-101, or  
equivalent, until the department terminates each pertinent registration requiring this  
record. The registrant shall retain records used in preparing department Form MIOSHA-  
RSS-101, or equivalent, for 3 years after the record is made.  
History: 2016 AACS.  
Editor's Note: An obvious error in R 333.5080 was corrected at the request of the promulgating  
agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL 24.256. The rule  
containing the error was published in Michigan Register, 2016 MR 10. The memorandum requesting the  
correction was published in Michigan Register, 2016 MR 16.  
R 333.5081 Records of individual monitoring results.  
Rule 81. (1) A registrant shall maintain records of doses received by all individuals  
for whom monitoring is required pursuant to R 333.5064. When applicable, these records  
shall include the deep-dose equivalent to the whole body, lens dose equivalent, shallow  
dose equivalent to the skin, and shallow dose equivalent to the extremities.  
(2) The registrant shall make entries of the records specified in subrule (1) of this  
rule at least annually.  
(3) The registrant shall maintain the records specified in subrule (1) of this rule on  
department Form MIOSHA-RSS-102, pursuant to the instructions for department Form  
MIOSHA-RSS-102, or in clear and legible records containing all the information  
required by department Form MIOSHA-RSS-102.  
(4) The registrant shall maintain the records of dose to an embryo or fetus with the  
records of dose to the declared pregnant woman. The declaration of pregnancy shall also  
be kept on file, but may be maintained separately from the dose records.  
(5) The registrant shall retain the required form or record until the department  
terminates each pertinent registration requiring the record.  
History: 2016 AACS.  
R 333.5082 Records of dose to individual members of the public.  
Rule 82. (1) A registrant shall maintain records sufficient to demonstrate compliance  
with the dose limit for individual members of the public as required by R 333.5060.  
(2) A registrant shall retain the records required by subrule (1) of this rule until the  
department terminates each pertinent registration requiring the record.  
History: 2016 AACS.  
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R 333.5083 Records of testing entry control devices for very high radiation  
areas.  
Rule 83. (1) A registrant shall maintain records of tests performed on entry control  
devices for very high radiation areas. These records shall include the date, time, and  
results of each test.  
(2) The registrant shall retain the records required by subrule (1) of this rule for 3  
years after the record is made.  
History: 2016 AACS.  
R 333.5084 Form of records.  
Rule 84. (1) A record required by these rules shall be legible, readily identifiable, and  
retrievable throughout the specified retention period. The record shall be 1 of the  
following:  
(a) The original.  
(b) A reproduced copy.  
(c) An electronic copy stored in an electronic recordkeeping system.  
(d) A microform if it is authenticated by authorized personnel and is capable of  
producing a clear copy throughout the required retention period.  
(2) Records, such as letters, drawings, and specifications, shall include all pertinent  
information, such as stamps, initials, and signatures.  
(3) The registrant shall maintain adequate safeguards against tampering with and loss  
of records.  
History: 2016 AACS.  
NOTIFICATIONS AND REPORTS  
R 333.5086 Notifications and reports of theft or loss of registered radiation  
machines.  
Rule 86. (1) A registrant shall notify the department by telephone of a stolen, lost, or  
missing radiation machine within 10 days after its absence becomes known.  
(2) A registrant required to notify the department under subrule (1) of this rule shall,  
within 30 days after making the telephone notification, make a written report to the  
department containing all of the following information:  
(a) A description of the radiation machine involved, including the manufacturer and  
model, and the registration tag number of the radiation machine.  
(b) A description of the circumstances under which the loss or theft occurred.  
(c) A statement of disposition, or probable disposition, of the radiation machine  
involved.  
(d) Exposures of individuals to radiation, the circumstances under which the  
exposures occurred, and the possible total effective dose equivalent to individuals in  
unrestricted areas.  
(e) Actions that have been taken, or will be taken, to recover the radiation machine.  
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(f) Actions taken or planned to prevent a recurrence of the loss or theft of the  
radiation machine.  
(3) After filing the written report, the registrant shall make an additional written  
report to the department containing any additional substantive information regarding the  
loss or theft within 30 days after the registrant learns of the new information.  
(4) The registrant shall prepare a report filed with the department pursuant to this  
rule so that the names of individuals who may have received exposure to radiation are  
contained in a separate and detachable part of the report.  
History: 2016 AACS.  
R 333.5087 Notification of incidents.  
Rule 87. (1) In addition to any other requirements for notification, a registrant shall  
immediately notify the department of an event involving a radiation machine possessed  
by the registrant that may have caused or threatens to cause an individual to receive any  
of the following:  
(a) An effective dose equivalent of 0.25 sievert (25 rem) or more.  
(b) A lens dose equivalent of 0.75 sievert (75 rem) or more.  
(c) A shallow dose equivalent to the skin or extremities of 2.5 grays (250 rads) or  
more.  
(2) Within 24 hours of discovery of the event, a registrant shall notify the department  
of an event involving a registered radiation machine possessed by the registrant that may  
have caused, or threatens to cause, an individual to receive, in a period of 24 hours, any  
of the following:  
(a) An effective dose equivalent exceeding 0.05 sievert (5 rem).  
(b) A lens dose equivalent exceeding 0.15 sievert (15 rem).  
(c) A shallow dose equivalent to the skin or extremities exceeding 0.5 sievert (50  
rem).  
(3) Registrants shall make the notifications required by subrules (1) and (2) of this  
rule by telephone to the department and shall confirm the notification within 24 hours by  
e-mail, facsimile, or overnight mail to the department.  
(4) The registrant shall prepare the written confirmation filed with the department  
pursuant to this rule so that the names of individuals who have received an exposure to  
radiation are contained in a separate and detachable part of the written confirmation.  
History: 2016 AACS.  
R 333.5088 Reports of exposures and radiation levels exceeding limits.  
Rule 88. (1) In addition to the notification required by R 333.5087, a registrant shall  
submit a written report to the department within 30 days after learning of any of the  
following occurrences:  
(a) An event requiring notification under R 333.5087.  
(b) A dose exceeding any of the following:  
(i) The occupational dose limits for adults in R 333.5057.  
(ii) The occupational dose limits for a minor in R 333.5058.  
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(iii) The limit for an embryo or fetus of a declared pregnant woman in R 333.5059.  
(iv) The limits for a member of the public in R 333.5060.  
(v) Any applicable limit in the registration.  
(c) Levels of radiation in either of the following conditions:  
(i) A restricted area exceeding an applicable limit in the registration.  
(ii) An unrestricted area exceeding 10 times an applicable limit in this part or in the  
registration, whether or not this involves a dose to an individual in excess of the limits in  
R 333.5060.  
(2) A written report required by subrule (1) of this rule shall include, as appropriate,  
all of the following:  
(a) The registrant’s name, address, and facility registration number.  
(b) A description of the event, including the possible cause and the manufacturer and  
model number, if applicable, of any equipment that failed or malfunctioned.  
(c) The location of the event.  
(d) The date and time of the event.  
(e) The results of any evaluations or assessments, including an estimate of each  
individual's dose and the levels of radiation involved.  
(f) Actions taken or planned to prevent a recurrence, including the schedule for  
achieving conformance with applicable limits and applicable registration conditions.  
(3) After filing a report required by this rule, the registrant shall make an additional  
written report to the department containing any additional substantive information  
regarding the event within 30 days after the registrant learns of the new information.  
(4) A report filed with the department under this rule shall include the name, a unique  
identification number or social security number as appropriate, and the date of birth of  
each overexposed individual. The report shall be prepared so that the information is  
contained in a separate and detachable part of the report and shall be clearly labeled  
“Protected Information: Not for Public Disclosure.”  
History: 2016 AACS.  
R 333.5089 Reports to individuals of exceeding dose limits.  
Rule 89. When R 333.5088 requires a registrant to report to the department, the  
registrant shall also provide to any affected individual a report on his or her exposure data  
included in the report submitted to the department. This report shall be transmitted no  
later than the transmittal to the department.  
History: 2016 AACS.  
PART 4. NOTICES, INSTRUCTIONS AND REPORTS TO WORKERS;  
INSPECTIONS FOR USERS OF RADIATION MACHINES  
R 333.5091 Purpose and scope.  
Rule 91. This part establishes requirements for notices, instructions and reports by  
registrants to individuals engaged in activities associated with radiation machines and  
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options available to these individuals in connection with department inspections of  
registrants to determine compliance with the act and rules regarding radiological working  
conditions. The rules in this part apply to all persons who receive, possess, use, own, or  
transfer radiation machines registered with the department under R 333.5031 to  
R 333.5047.  
History: 2016 AACS.  
R 333.5092 Posting of notices to workers.  
Rule 92. (1) A registrant shall post current copies of the following documents or a  
notice that describes each document and states where it may be examined:  
(a) The rules in this part and R 333.5051 to R 333.5089.  
(b) The certificate of registration and all conditions or documents incorporated into  
the registration by reference.  
(c) The operating procedures applicable to activities under the registration.  
(2) A registrant shall post a notice of violation involving radiological working  
conditions, a proposed imposition of a civil penalty or order issued under R 333.5023 or  
R 333.5024, and required responses from the registrant.  
(3) A registrant shall post department Form MIOSHA-RSS-100 “Notice to  
Employees” as required by these rules.  
(4) A registrant shall conspicuously post documents, notices, and forms as required  
by this rule in a sufficient number of places to allow individuals engaged in work under  
the registration to observe them on the way to or from work locations to which the  
document applies, and shall replace a document if it is defaced or altered.  
(5) A registrant shall post documents pursuant to subrule (2) of this rule within 5  
working days after receipt of the documents from the department. The registrant's  
response shall be posted within 5 working days after dispatch from the registrant. These  
documents shall be posted for a minimum of 5 working days or until the violation has  
been corrected, whichever is later.  
History: 2016 AACS.  
R 333.5093 Instructions to workers.  
Rule 93. (1) A registrant shall ensure that each individual, who during employment is  
likely to receive in a year an occupational dose greater than 1 millisievert (100 mrem),  
shall be the following:  
(a) Instructed in the risks associated with exposure to radiation to the individual and  
potential offspring and in precautions or procedures to minimize exposure.  
(b) Instructed in, and required to observe, to the extent within the worker's control,  
the applicable provisions of these rules for the protection of personnel from exposures to  
radiation.  
(c) Instructed in his or her responsibility to report promptly to the registrant a  
condition that may constitute, lead to, or cause a violation of the act, these rules, a  
registration condition, or unnecessary exposure to radiation.  
(d) Instructed in the appropriate response to warnings made due to an unusual  
occurrence or malfunction that may involve exposure to radiation.  
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(e) Advised as to the radiation exposure reports that workers shall be provided  
pursuant to R 333.5094.  
(2) A registrant shall keep records of the instructions described in this rule.  
(3) The extent of these instructions shall be commensurate with the potential  
radiological hazards in the workplace.  
History: 2016 AACS.  
R 333.5094 Notifications and reports to individuals.  
Rule 94. (1) A registrant shall report radiation exposure data for an individual as  
specified in this rule. The information reported shall include data and results obtained  
pursuant to these rules, orders, or registration conditions, as shown in records kept by the  
registrant pursuant to R 333.5081. A notification and report shall be in writing and  
include all of the following:  
(a) The name of the registrant, the name of the individual, and the individual's unique  
identification number or social security number.  
(b) The individual's exposure information.  
(c) The following statement:  
"This report is provided to you pursuant to Part 4 of the Michigan Department of  
Licensing and Regulatory Affairs rules entitled ‘Ionizing Radiation Rules Governing the  
Use of Radiation Machines’. You should keep this report for future reference."  
(2) A registrant shall make dose information available to workers as shown in  
records kept by the registrant pursuant to R 333.5081. A registrant shall provide an  
annual report to each individual monitored pursuant to R 333.5064 of the dose received  
in that monitoring year for either of the following reasons:  
(a) The individual’s occupational dose exceeds 1 millisievert (100 mrem) effective  
dose equivalent or 1 millisievert (100 mrem) to an individual organ or tissue.  
(b) The individual requests his or her annual dose report.  
(3) At the request of a worker formerly engaged in work controlled by the registrant,  
the registrant shall provide a written report of the worker's exposure to radiation  
machines. The report shall include the dose record for each year the worker was required  
to be monitored pursuant to R 333.5064. The report shall be provided within 30 days  
from the date of the request, or within 30 days after the dose of the individual has been  
determined by the registrant, whichever is later. The report shall cover the period of time  
the worker's activities involved exposure to radiation machines. The report shall include  
the dates and locations of work associated with radiation machines in which the worker  
participated during this period.  
(4) When a registrant is required pursuant to R 333.5087 or R 333.5088 to report to  
the department an exposure of an individual to radiation, the registrant shall also provide  
the individual a written report of the exposure data included in the report. This report  
shall be transmitted at a time not later than the transmittal to the department.  
(5) At the request of a worker who is terminating employment with the registrant in  
work involving exposure to radiation during the current year, or at the request of a worker  
who, while employed by another person, is terminating a work assignment involving  
radiation exposure in the registrant's facility during the current year, each registrant shall  
provide at termination to the worker, or to the worker's designee, a written report of the  
radiation dose received by that worker from operations of the registrant during the current  
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year. If the most recent individual monitoring results are not available, a written estimate  
of the dose shall be provided. Estimated doses shall be clearly indicated as estimated  
doses.  
History: 2016 AACS.  
R 333.5096  
inspection.  
Presence of representatives of registrants and workers during  
Rule 96. (1) A registrant or an applicant for a registration shall allow the department  
at all reasonable times, the opportunity to inspect machines, activities, facilities,  
premises, and records under these rules.  
(2) During an inspection, the registrant shall allow department inspectors to consult  
privately with workers as specified in R 333.5097. The registrant may accompany  
department inspectors at times other than the private consultation with workers.  
(3) If the workers have authorized an individual to represent them during department  
inspections, the registrant shall notify the inspectors of the authorization and shall permit  
the workers' representative to accompany the inspectors during the inspection of physical  
working conditions.  
(4) A worker’s representative shall be routinely engaged in work under control of the  
registrant and shall have received instructions as specified in R 333.5093.  
(5) If there is no resulting interference with the conduct of the inspection, different  
representatives of registrants and workers may accompany the inspectors during different  
phases of an inspection. However, only 1 workers' representative at a time may  
accompany the inspectors.  
(6) With the approval of the registrant and the workers' representative, an individual  
who is not routinely engaged in work under control of the registrant, for example, a  
consultant to the registrant or to the workers' representative, may accompany department  
inspectors during the inspection of physical working conditions.  
(7) Department inspectors may refuse to permit accompaniment by an individual  
who deliberately interferes with a fair and orderly inspection.  
(8) Unless previously authorized by the registrant, a worker’s representative shall  
not have access to an area containing proprietary information.  
History: 2016 AACS.  
R 333.5097 Consultation with workers during inspections.  
Rule 97. (1) Department inspectors may consult privately with workers concerning  
matters of occupational radiation protection and other matters related to applicable  
provisions of these rules to the extent that the inspectors consider necessary for the  
conduct of an effective and thorough inspection.  
(2) During an inspection, a worker may report privately to the inspectors, either  
orally or in writing, a past or present condition that the worker believes may have  
contributed to or caused a violation of the act, these rules, a registration condition, or  
unnecessary exposure of an individual to radiation from machines under the registrant's  
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control. If this notice is in writing, the worker shall comply with the requirements of  
R 333.5098(1).  
(3) The provisions of subrule (2) of this rule shall not be interpreted as authorization  
to disregard instructions pursuant to R 333.5093.  
History: 2016 AACS.  
R 333.5098 Requests by workers for inspections.  
Rule 98. (1) A worker or a representative of workers who believes that a violation of  
the act, these rules, or registration conditions exists or has occurred regarding  
radiological working conditions may request an inspection of the facility by the  
department. The request shall be in writing, describe the circumstances of the perceived  
violation or condition, and be signed by the worker or the representative of the workers.  
The department shall provide a copy of the request to the registrant before or during the  
inspection. At the request of the worker, the department shall protect the worker's name  
and the name of individuals referred to in the request, except for good cause shown.  
(2) If, upon receipt of a request for an inspection, the department determines that the  
complaint meets the requirements of subrule (1) of this rule, and that there are reasonable  
grounds to believe that the alleged violation exists or has occurred, an inspection shall be  
made as soon as practical to determine if the alleged violation exists or has occurred. An  
inspection authorized by this rule need not be limited to matters referred to in the  
complaint.  
History: 2016 AACS.  
R 333.5100 Inspections not warranted; informal review.  
Rule 100. (1) If the department determines, with respect to a complaint filed pursuant  
to R 333.5098, that an inspection is not warranted because there are no reasonable  
grounds to believe that a violation exists or has occurred, the department shall notify the  
complainant in writing of the determination. To request a review of the determination the  
claimant shall submit a written statement of position to the department director. The  
department director, or his or her designated representative, shall send the registrant a  
copy of the statement by certified mail, excluding, at the request of the complainant, the  
name of the complainant. The registrant may submit an opposing written statement of  
position to the department director. The department director, or his or her designated  
representative, shall send the complainant a copy of the statement by certified mail.  
(2) At the request of the complainant, the department may hold an informal  
conference in which the complainant and the registrant may orally present their views.  
An informal conference may also be held at the request of the registrant, but disclosure of  
the identity of the complainant shall be made only following receipt of written  
authorization from the complainant. After considering all written and oral views  
presented, the department director, or designated representative shall affirm, modify, or  
reverse the determination of the department and provide the complainant and the  
registrant a written notification of the decision. The notification shall include a  
discussion of the basis for the decision.  
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(3) If, upon receipt of a request for an inspection, the department determines that an  
inspection is not warranted because the complaint does not meet the requirements of  
R 333.5098(1), the department shall notify the complainant in writing of the  
determination. The determination shall be without prejudice to the filing of a new  
complaint meeting the requirements of R 333.5098(1).  
History: 2016 AACS.  
R 333.5101 Employee protection.  
Rule 101. Employment discrimination by a registrant, or contractor or subcontractor  
of a registrant against an employee for engaging in protected activities under this part is  
prohibited.  
History: 2016 AACS.  
PART 5. OPERATOR QUALIFICATIONS  
R 333.5201 Purpose and scope.  
Rule 5201. (1) This part establishes the qualification requirements of individuals  
engaged in medical radiologic technology. Improper performance of medical radiologic  
technology results in unnecessary exposure to machine produced ionizing radiation and  
the unnecessary re-administration of machine produced ionizing radiation. Therefore, the  
qualification of these individuals to apply machine produced ionizing radiation to  
humans has a direct impact on the machine produced ionizing radiation burden of the  
patient.  
(2) Unless specifically exempt in accordance with R 333.5209, a registrant shall  
not employ an individual to perform medical radiologic technology who does not meet  
the requirements of this part or without the expressed written approval of the  
department.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5202 Definitions; A.  
Rule 5202. (1) “ACRRT” means American Chiropractic Registry of Radiologic  
Technologists.  
(2) "Approved program" means a formal education program in the respective  
discipline of radiography or radiation therapy that is accredited by 1 or more of the  
following:  
(a) Joint Review Committee on Education in Radiologic Technology.  
(b) Regional institutional accrediting agencies.  
(c) Conjoint Secretariat of the Canadian Medical Association.  
(3) “ARRT” means American Registry of Radiologic Technologists.  
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History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5203 Definitions; B.  
Rule 5203. "Bone densitometry" means the science and art of applying machine  
produced ionizing radiation to human beings for the determination of site-specific bone  
density.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5204 Definitions; C.to G.  
Rule 5204. (1) “CAMRT” means Canadian Association of Medical Radiation  
Technologists.  
(2) “CBRPA” means Certification Board for Radiology Practitioner Assistants.  
(3) “CCI” means Cardiovascular Credentialing International.  
(4) "Chiropractic radiography" means the science and art of applying machine  
produced ionizing radiation to human beings for diagnostic evaluation of skeletal  
anatomy.  
(5) "Continuing education activity" means a learning activity that is planned,  
organized, and administered to enhance the professional knowledge and skills  
underlying professional performance that a medical radiologic technologist uses to  
provide services for patients, the public, or the medical profession. T o qualify as  
continuing education, the activity must be planned and organized t o provide  
sufficient depth and scope of a subject area.  
(6) "CE credit" or continuing education credit means a unit of measurement for  
continuing education activities. One CE credit is awarded for 1 contact hour, which is  
50 minutes. Activities longer than 1 hour are assigned whole or partial credits based on  
the 50-minute hour.  
(7) “Direct supervision” means the required individual must be present in at  
least an adjacent area and immediately available to furnish assistance and direction  
throughout the procedure, and is responsible for the control of quality, radiation safety  
protection, and technical aspects of the application of radiation to human beings for  
diagnostic, therapeutic, or research purposes.  
(8) “General supervision” means the procedure is furnished under the overall  
direction and control of a licensed practitioner whose presence is not required during  
the performance of the procedure., and is responsible for the control of quality,  
radiation safety protection, and technical aspects of the application of radiation to  
human beings for diagnostic, therapeutic, or research purposes.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5205 Definitions; L.  
Rule 5205. (1) "Licensed practitioner" means a health practitioner licensed under  
article 15 of the public health code, 1978 PA 368, MCL 333.16101 to 333.18838.  
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(2) “Limited diagnostic radiographer” means an individual, other than a licensed  
practitioner, who, while under the general supervision of a licensed practitioner, performs  
limited diagnostic radiography.  
(3) “Limited diagnostic radiography” means the science and art of applying  
machine produced ionizing radiation to human beings for limited diagnostic purposes.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5206 Definitions; M.  
Rule 5206. (1) "Medical radiologic technologist" means an individual, other than  
a licensed practitioner, who, while under the general supervision of a licensed  
practitioner performs medical x -radiation procedures involving the application of  
machine produced ionizing radiation to human beings for diagnostic, therapeutic, and  
research purposes.  
(2) "Medical radiologic technology" means the science and art of performing  
medical x -radiation procedures involving the application of machine produced ionizing  
radiation to human beings for diagnostic, therapeutic, and research purposes. The  
specialized disciplines of medical radiologic technology are medical radiography,  
radiation therapy technology, chiropractic radiography, limited diagnostic radiography,  
and radiologist assistant.  
(3) "Medical radiographer" means an individual, other than a licensed  
practitioner, who, while under the general supervision of a licensed practitioner,  
applies machine produced ionizing radiation to a part of the human body.  
(4) "Medical radiography" means the science and art of applying machine  
produced ionizing radiation to human beings for diagnostic, and research purposes.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5207 Definitions; P.  
Rule 5207. (1) “Personal supervision” means the required individual i s in  
attendance in the room during the performance of a procedure, and is responsible for  
the control of quality, radiation safety and protection, and technical aspects of the  
application of radiation to human beings for diagnostic, therapeutic, or research  
purposes.  
(2) "Physician's assistant" means an individual who is licensed as a physician's  
assistant under part 170 or part 175 of the public health code, 1978 PA 368, MCL  
333.17001 to 333.17097 and 333.17501 to 333.17556.  
(3) "Podiatric" means a radiographic examination of the toes, foot, ankle, calcaneus,  
and distal tibia/fibula but does not include the knee joint.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5208 Definitions; R.  
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Rule 5208. (1) "Radiation therapy technology" means the science and art of  
applying radiation emitted from x-ray machines or particle accelerators to human  
beings for therapeutic purposes.  
(2) "Radiologist assistant" means an individual, other than a licensed practitioner,  
who as a medical radiographer with advanced-level training and certification, performs a  
variety of activities under the direct, general, or personal supervision of a radiologist,  
certified by the American Board of Radiology (ABR), the American Osteopathic  
Board of Radiology (AOBR), or Royal College of Physicians and Surgeons of Canada  
(RCPSC), in the areas of patient care, patient management, clinical imaging, and  
interventional procedures. The radiologist assistant shall not interpret images, make  
diagnoses, or prescribe medications or therapies.  
(3) "Radiology" means the branch of medicine that deals with the study and  
application of imaging technology to diagnose and treat disease.  
(4) "RCEEM" or “recognized continuing education evaluation mechanism” means  
a mechanism used by the ARRT for evaluating the content, quality, and integrity of an  
educational activity. The evaluation shall include a review of education objectives,  
content selection, faculty qualifications, and educational methods and materials.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5209 Exemptions.  
Rule 5209. (1) Nothing in this part shall be construed to limit or affect in any  
respect, the medical practice of individuals properly licensed under article 15 of the  
public health code, 1978 PA 368, MCL 333.16101 to 333.18838 with respect to their  
professions and scope of practice.  
(2) The following individuals are exempt from the requirements of this part:  
(a) A student enrolled in an approved program applicable to his or her profession  
who, as a part of his or her course of study, applies machine produced ionizing radiation  
to human beings while under the direct supervision of a licensed practitioner or medical  
radiologic technologist who meets the requirements of this part.  
(b) An individual employed as a dental assistant or dental hygienist who  
performs radiography under the general supervision of a licensed practitioner.  
(c) A nurse, technician, or other assistant who, under the general supervision of a  
licensed practitioner, performs bone densitometry.  
(d) A medical radiologic technologist performing mammography who meets the  
qualification requirements of R 333.5630.  
(e) A computed tomography (CT) operator who meets the qualification  
requirements of R 333.5705.  
(f) A nuclear medicine technologist who, under the supervision of an authorized  
user, utilizes sealed and unsealed radioactive materials for diagnostic, treatment, and  
research purposes.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5210 Categories and types of qualification.  
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Rule 5210. (1) The department recognizes all of the following categories in the  
practice of medical radiologic technology:  
(a) Medical radiography.  
(b) Radiation therapy technology.  
(c) Radiologist assistant.  
(d) Chiropractic radiography.  
(e) Limited diagnostic radiography.  
(2) The department recognizes the following types of qualifications:  
(a) Active status for individuals who have passed an examination as indicated in  
R 333.5211 and who maintain current registration status with the registry providing the  
examination.  
(b) Temporary status for individuals who have completed an approved program in  
medical radiography, radiation therapy technology, radiologist assistant, chiropractic  
radiography, or cardiac catheterization and interventional radiography and are eligible  
for the examination required to obtain the credential or credentials specified in R  
333.5211. Temporary status conveys the same rights as active status. Temporary status  
must not exceed 3 years after completion of the approved program.  
(c) Limited diagnostic radiography for individuals who have completed the training  
required in R 333.5212. Limited diagnostic radiography procedures that require specific  
limited qualifications are as follows:  
(i) Limited diagnostic radiography – chest:  
(A) Posterior anterior upright.  
(B) Anterior posterior supine.  
(C) Lateral upright.  
(D) Lateral decubitus.  
(E) Anterior posterior lordotic.  
(F) Obliques.  
(ii) Limited diagnostic radiography – extremities:  
(A) Finger or fingers.  
(B) Forearm.  
(C) Shoulder.  
(D) Toes.  
(E) Tibia and fibula.  
(F) Femur.  
(G) Hand.  
(H) Elbow.  
(I) Clavicle.  
(J) Foot.  
(K) Knee.  
(L) Wrist.  
(M) Humerus.  
(N) Scapula.  
(O) Ankle.  
(P) Patella.  
(iii) Limited diagnostic radiography – spine:  
(A) Cervical spine.  
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(B) Sacroiliac joints.  
(C) Thoracic spine.  
(D) Sacrum.  
(E) Lumbar spine.  
(F) Coccyx.  
(iv) Limited diagnostic radiography - skull and sinuses:  
(A) Skull.  
(B) Paranasal sinuses.  
(C) Mandible facial bones.  
(v) Limited diagnostic radiography – podiatric:  
(A) Foot.  
(B) Ankle.  
(d) Conditional status for individuals can occur during the 3 years immediately  
following the effective date of this part. A medical radiologic technologist that does not  
meet the requirements of subdivision (a), (b), or (c) of this subrule shall be considered  
qualified contingent upon a written statement of assurance that the individual is  
competent to apply machine produced ionizing radiation to human beings. This statement  
of assurance must be maintained for inspection by the department and must specify the  
nature of the equipment and procedures the individual is competent to utilize. The  
statement of assurance must be provided by a licensed practitioner under whose general  
supervision the individual is employed or has been employed. Three years after the  
effective date of this part, a medical radiologic technologist shall meet the requirements  
of subdivision (a), (b), or (c) of this subrule.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5211 Credentialing requirements.  
Rule 5211. Individuals who seek to qualify for active status in medical radiologic  
technology shall possess the appropriate credential or credentials as specified below or  
equivalent:  
(a) Medical radiography:  
(i) ARRT – radiography (R).  
(ii) CAMRT – registered technologist, radiation technology (RTR).  
(b) Radiation therapy technology:  
(i) ARRT – registered radiation therapists (RTT).  
(ii) CAMRT – registered radiation therapists (RTT).  
(c) Radiologist assistant:  
(i) ARRT – registered radiologist assistant (RRA).  
(ii) CBRPA – radiology practitioner assistant (RPA).  
(d) Chiropractic radiography provided through ACRRT.  
(e) Cardiac catheterization and interventional radiography:  
(i) ARRT – cardiovascular interventional radiography (CV).  
(ii) ARRT – cardiac interventional radiography (CI).  
(iii) ARRT – vascular interventional radiography (VI).  
(iv) CCI – registered cardiovascular invasive specialist (RCIS).  
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History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5212 Limited diagnostic radiography requirements.  
Rule 5212. (1) Individuals who perform limited diagnostic radiography shall pass an  
approved program or obtain a minimum of 40 hours of training relevant to the radiologic  
science within the limited scope of practice. This training must include both clinical and  
didactic components.  
(2) The following general categories must be included in limited diagnostic  
radiography training or program:  
(a) Fundamentals of healthcare.  
(b) Medical terminology.  
(c) Patient care and management.  
(d) Human anatomy and physiology.  
(e) Imaging production and evaluation.  
(f) Imaging equipment and radiation production.  
(g) Radiation protection and radiobiology.  
(3) In addition to the categories in subrule (2) of this rule, the curriculum must  
include the following:  
(a) Limited chest radiography programs must include instruction on chest  
radiography procedures.  
(b) Limited extremity programs must include instruction on extremity radiographic  
procedures.  
(c) Limited spine programs must include instruction on spine radiographic  
procedures.  
(d) Limited skull and sinus programs must include instruction on skull and sinus  
radiographic procedures.  
(e) Limited podiatry programs must include instruction on foot, ankle, and leg  
below the knee radiographic procedures.  
(4) Limited diagnostic radiography programs must be competency-based educational  
programs.  
(5) All limited diagnostic radiographers are required to maintain proof of  
completion of approved program or training.  
History: 2024 MR 6, Eff. March 13, 2024.  
R 333.5213 Continuing education requirements.  
Rule 5213. (1) The required number of CE credits for limited diagnostic  
radiography is 12 CE credits.  
(2) CE credits required by subrule (1) of this rule must be completed within 24  
months after the effective date of these rules and every 24 months after their initial  
completion.  
(3) The options for meeting CE requirements are any of the following:  
(a) Activities approved by an RCEEM. Among the requirements for qualification  
as an RCEEM, an organization shall be national in scope, non-profit, radiology based,  
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and willing to evaluate CE activity developed by a medical radiologic technologist  
within a given discipline. Organizations with current RCEEM status include:  
(i) American College of Radiology.  
(ii) American Healthcare Radiology Administrators.  
(iii) American Institute of Ultrasound in Medicine.  
(iv) American Roentgen Ray Society.  
(v) American Society of Nuclear Cardiology.  
(vi) American Society of Radiologic Technologists.  
(vii) Association of Vascular and Interventional Radiographers.  
(viii) Canadian Association of Medical Radiation Technologists.  
(ix) Medical Dosimetrist Certification Board.  
(x) Radiological Society of North America.  
(xi) Society of Diagnostic Medical Sonography.  
(xii) Section for Magnetic Resonance Technologist of the International Society  
for Magnetic Resonance in Medicine.  
(xiii) Society of Nuclear Medicine Technologist Section.  
(xiv) Society of Vascular Ultrasound.  
(b) Approved academic courses offered by a post-secondary educational  
institution that are relevant to the radiologic sciences or patient care, or both. Courses  
in the biologic sciences, physical sciences, verbal and written communication,  
mathematics, computers, management, or education methodology are considered  
relevant. Credit is awarded at the rate of 12 CE credits for each academic quarter or  
16 CE credits for each academic semester credit.  
(c) Advanced cardiopulmonary resuscitation (CPR) certification, including  
advanced life support, instructor, or instructor trainer, through the American Red Cross,  
the American Heart Association, or the American Safety and Health Institute is  
awarded 6 CE credits.  
(4) All limited diagnostic radiographers are required to maintain proof of  
participation in continuing education activities. P roo f may be in the form of a  
certificate or an itemized list from an ARRT-approved record-keeping mechanism.  
History: 2024 MR 6, Eff. March 13, 2024.  
PART 6. INDUSTRIAL RADIOGRAPHIC OPERATIONS AND  
INSTALLATIONS  
R 333.5281 Purpose and scope.  
Rule 281. (1) This part establishes radiation safety requirements for persons utilizing  
radiation machines for industrial radiography and a classification system for industrial  
radiographic installations and use.  
(2) This part applies to all registrants who use radiation machines for industrial  
radiography. Nothing in this part applies to the use of radiation machines by a health  
practitioner licensed under article 15 of the act.  
(3) In addition to the requirements of this part, all registrants are subject to the  
applicable provisions of the other parts of these rules.  
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History: 2016 AACS.  
R 333.5282 Definitions.  
Rule 282. As used in this part:  
(a) "Industrial radiography" means the examination of the macroscopic structure of  
materials by nondestructive methods utilizing radiation machines.  
(b) "Installation" means a location, having boundaries specified by the registrant,  
where for a period of more than 30 days 1 or more radiation machines are used. A part of  
a building, an entire building, a plant, or plant site may be designated as an installation.  
(c) "Radiographer" means an individual who performs or who, in attendance at the  
site where radiation machines are being used, personally supervises class D radiographic  
operations and who is responsible to the registrant for assuring compliance with the  
requirements of these rules and all registration conditions.  
(d) "Radiographer's assistant" means an individual who, under the personal  
supervision of a radiographer, uses radiation machines or survey instruments in class D  
radiographic operations.  
History: 2016 AACS.  
CLASSIFICATION  
R 333.5293 Class enumeration.  
Rule 293. (1) For registration and approval purposes, industrial radiographic  
installations shall be classified as class AA, class A, class B, or class C.  
(2) For the purpose of registering and approving industrial radiography and radiation  
machines intended for limited use at temporary job site locations, this use shall be  
classified as a class D operation.  
History: 2016 AACS.  
R 333.5294 Class AA installations.  
Rule 294. (1) In class AA installations the radiation machine and objects exposed  
thereto shall be contained within a permanent enclosure.  
(2) The enclosure shall be constructed such that the radiation dose rate at a distance of  
5 centimeters from any point on the external surface shall not exceed 0.02 millisievert per  
hour (2 mrem/h). The dose rate shall be measured with the source of radiation placed at  
the position of closest source-wall distance that is radiographically usable and under  
conditions of maximum radiation output permitted by the design or operating  
characteristics of the radiation machine.  
(3) Mechanical or electrical limiters shall limit movement or alignment of the  
radiation machine within the enclosure if necessary to comply with subrule (2) of this  
rule.  
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(4) A personnel barrier posted pursuant to R 333.5067 to R 333.5072 restricting  
access to the roof of the enclosure shall meet the requirement of subrule (2) of this rule.  
(5) Reliable interlocks shall be provided which will prevent anyone from opening the  
enclosure while the radiation machine is on or which will terminate machine operation  
should anyone open the enclosure.  
(6) Enclosures of sufficient size to permit human occupancy shall be provided with  
visible signals or audible signals, or both, within the enclosure, which are activated a  
minimum of 5 seconds before radiation machine activation. Individuals shall at all times  
be able to escape from within the enclosure.  
(7) Individuals shall not be permitted to remain within the enclosure while the  
radiation machine is in operation.  
(8) Protective enclosures and equipment shall be kept in good repair.  
(9) Industrial fluoroscopy shall meet the requirements of class AA installations.  
(10) Notwithstanding the provisions of subrule (2) of this rule, the enclosure for  
industrial fluoroscopy shall be constructed such that the radiation dose rate at a distance  
of 5 centimeters from any accessible point on the external surface shall not exceed 0.005  
millisievert per hour (0.5 mrem/h) under conditions of maximum radiation output  
permitted by the design or operating characteristics of the installation.  
(11) Industrial cabinet radiography conducted in enclosures of insufficient size to  
permit human occupancy shall meet the requirements of class AA installations.  
(12) Notwithstanding the provisions of subrule (2) of this rule, the enclosure for  
industrial cabinet radiography of insufficient size to permit human occupancy shall be  
constructed such that the radiation dose rate at a distance of 5 centimeters from any  
accessible point on the external surface shall not exceed 0.005 millisievert per hour (0.5  
mrem/h) under conditions of maximum radiation output permitted by the design or  
operating characteristics of the installation.  
(13) For class AA enclosures of sufficient size to permit human occupancy, a  
personnel radiation dosimeter shall be permanently assigned to each occupationally  
exposed individual. This monitoring shall be continuous during employment as a  
radiation worker.  
(14) Personnel exposure records shall be kept on permanent available file at the  
facility where the exposure occurs for inspection by the department.  
(15) Class AA approval permits unlimited use at maximum capacity.  
History: 2016 AACS.  
R 333.5296 Class A installations.  
Rule 296. (1) Class A installations shall comply with all requirements of R 333.5294  
except for a permissible dose rate of 0.07 millisievert per hour (7 mrem/h) at any  
accessible external point.  
(2) A personnel radiation dosimeter shall be permanently assigned to each  
occupationally exposed individual. This monitoring shall be continuous during  
employment as a radiation worker.  
(3) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs for inspection by the department.  
(4) Class A approval permits unlimited use at maximum capacity.  
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History: 2016 AACS.  
R 333.5297 Class B installations.  
Rule 297. (1) Class B installations shall comply with all requirements of R 333.5296.  
(2) Radiation machine current and potential controls shall be mechanically or  
electrically limited so as not to exceed the normal operating conditions as specified by the  
registrant at the time of application for registration.  
(3) Class B approval permits unlimited use under normal operating conditions as  
specified by subrule (2) of this rule.  
History: 2016 AACS.  
R 333.5298 Class C installations.  
Rule 298. (1) Class C installations shall comply with all requirements of R 333.5296  
except for a permissible dose rate of 0.5 millisievert (50 mrem) per hour at any accessible  
external point.  
(2) The maximum weekly exposure time of radiation machines within the enclosure  
shall be established by the department under the conditions specified by the registrant at  
the time of application.  
(3) Warning signs shall be posted in those areas outside the enclosure in which the  
radiation dose rate at any accessible external point exceeds 0.02 millisievert per hour (2  
mrem/h). The dose rate shall be measured with the radiation machine tube placed at  
position of nearest source-wall distance that is radiographically usable under conditions  
of maximum radiation output permitted by the design or limited operating characteristics  
of the radiation machine.  
History: 2016 AACS.  
R 333.5299 Class D operations.  
Rule 299. (1) Industrial radiography conducted under conditions not meeting the  
provisions and requirements of R 333.5294 to R 333.5298 shall be classified as class D  
operations and shall not be operated longer than 30 days unless written authorization is  
granted by the department.  
(2) Written authorization may be granted by the department for class D operations  
longer than 30 days but not longer than 6 months when an undue and unnecessary  
hardship may result from the 30-day limitation. Written request by the registrant for this  
authorization is required and shall describe the hardship involved as well as provide  
written assurance of compliance with the requirements of these rules for class D  
operations.  
(3) Notwithstanding subrules (1) and (2) of this rule, a registrant routinely engaged in  
providing industrial radiography services with mobile or portable radiation machines at  
temporary job site locations may conduct such class D operations without time limitation  
subject to all of the following conditions:  
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(a) The registrant shall give written notice to the department at least 2 working days  
before starting radiographic work at a job site. The notice shall include the radiographer's  
name; the machine registration number; the nature, duration, and scope of use; and the  
exact location of each job site. If the 2 work-day period would impose an undue hardship  
on the registrant, upon application to the department, he or she may arrange for other  
notification to comply with the intent of this requirement.  
(b) These class D operations shall be limited to locations and circumstances which  
cannot meet the provisions and requirements of permanent installation classification  
without undue and unnecessary hardship.  
(c) A copy of written operating and emergency procedures shall be filed with and  
approved by the department.  
(d) Upon reasonable notice from the department, the registrant shall submit to the  
department or otherwise make available copies of specific records pertaining to  
radiographic operations and personnel conducting these operations within this state.  
(4) A fence, rope, or other suitable barrier shall be erected along the 0.05 millisievert  
per hour (5 mrem/h)contour line during class D radiographic operations to exclude  
unauthorized individuals from the radiation area.  
(5) Notwithstanding the requirements of R 333.5073, the radiation area and high  
radiation area shall be posted with caution signs as specified in R 333.5067 to  
R 333.5072.  
(6) A registrant shall not permit an individual to act as a radiographer or as a  
radiographer's assistant unless, at all times during radiographic operation, the individual  
wears a long-term monitoring device such as a film badge or TLD and a short-term  
monitoring device such as a pocket dosimeter or pocket chamber. Pocket dosimeters and  
pocket chambers shall be capable of measuring doses from 0 to at least 2 millisieverts  
(200 mrem). A long-term monitoring device shall be assigned to and worn by only 1  
individual.  
(7) Pocket dosimeters and pocket chambers shall be read and doses recorded daily. A  
film badge or similar device shall be immediately processed if a pocket chamber or  
pocket dosimeter is discharged beyond its range. All personnel exposure reports and  
records of pocket dosimeter and pocket chamber readings shall be maintained for  
inspection by the department.  
(8) Written operating and emergency procedures shall be available at each class D  
radiographic operation.  
History: 2016 AACS.  
REQUIREMENTS FOR CLASS D RADIOGRAPHIC OPERATIONS  
R 333.5302 Operating and emergency procedures.  
Rule 302. A registrant's written operating and emergency procedures for class D  
radiographic operations shall include instructions in at least the following:  
(a) The use of radiation machines to be employed such that an individual is not likely  
to be exposed to radiation doses in excess of the limits established in R 333.5057 to  
R 333.5061.  
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(b) Methods and occasions for conducting radiation surveys.  
(c) Methods for controlling access to radiographic areas.  
(d) Personnel monitoring and the use of individual monitoring devices.  
(e) Transportation to field locations, including packing of radiation machines in the  
vehicles, posting of vehicles, and control of radiation machines during transportation.  
(f) Minimizing exposure of persons in the event of an accident.  
(g) Procedure for notifying proper persons in the event of an accident.  
(h) Maintenance of records.  
(i) Inspection and maintenance of radiation machines.  
History: 2016 AACS.  
R 333.5305 Security.  
Rule 305. (1) During each class D radiographic operation, the radiographer or  
radiographer's assistant shall maintain a direct surveillance of the operation to protect  
against unauthorized entry into a high radiation area, except where the high radiation area  
is equipped with interlocks as described in R 333.5294 (5), or where the high radiation  
area is locked to protect against unauthorized or accidental entry.  
(2) A radiographer or radiographer's assistant shall not perform or permit class D  
radiographic operation unless all individuals present in or entering the resulting radiation  
area are wearing individual monitoring devices.  
History: 2016 AACS.  
R 333.5306 Radiation surveys and survey records.  
Rule 306. (1) A class D radiographic operation shall not be conducted unless  
calibrated and operable radiation survey instrumentation, as described in R 333.5307, is  
available and used at each site where radiographic exposures are made.  
(2) For class D radiographic operations, a physical radiation survey shall be  
conducted to determine that the radiation machine is off before each entry into the  
radiographic exposure area.  
History: 2016 AACS.  
R 333.5307. Radiation survey instruments.  
Rule 307. (1) A registrant shall maintain calibrated and operable radiation survey  
instruments to make physical radiation surveys as required by R 333.5306 and  
R 333.5063. A radiation survey instrument shall be calibrated at least annually and after  
each instrument servicing. A record of the calibration shall be maintained for  
examination by the department.  
(2) Instrumentation required by this rule shall have a range such that 0.02 millisievert  
per hour (2 mrem/h) through 0.01 sievert per hour (1 rem/h) can be measured and shall  
be capable of measuring radiation of the energies and at the dose rates to be encountered.  
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(3) During repair or calibration of survey instruments required by this rule, spare  
operable and calibrated instruments shall be provided or class D radiographic operations  
shall be terminated pursuant to R 333.5306(1).  
History: 2016 AACS.  
R 333.5308 Utilization logs.  
Rule 308. A registrant shall maintain for inspection by the department current logs,  
which contain all of the following information for each radiation machine:  
(a) The machine registration number.  
(b) The identity of the radiographer to whom the machine is assigned.  
(c) The locations where used and dates of use.  
(d) The signature or initials of the individual certifying each entry.  
History: 2016 AACS.  
R 333.5309 Limitations for radiographers and radiographer assistants.  
Rule 309. (1) A registrant shall not permit an individual to act as a radiographer until  
all of the following have been met:  
(a) The individual was instructed in the subjects outlined in table 309 and has  
demonstrated understanding of these subjects.  
TABLE 309  
Instruction of radiographers  
I
Fundamentals of Radiation Safety  
A. Characteristics of x-radiation  
B. Units of radiation dose  
C. Hazards of excessive radiation exposure  
D. Levels of radiation from radiation machines  
E. Methods of controlling radiation dose  
1. Working time  
2. Working distances  
3. Shielding  
I
I
Radiation Detection Instrumentation to be Used  
I
A. Use of radiation survey instruments  
1. Operation  
2. Calibration  
3. Limitations  
B. Survey techniques  
C. Use of individual monitoring devices  
Radiographic Equipment to be Used  
II.  
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A. Operation and control of x-ray equipment  
I
The Requirements of Pertinent State Regulations  
The Registrant's Written Operating and Emergency Procedures  
Registration Conditions  
V.  
.
V
V
I.  
(b) The individual received copies of and instruction in the rules contained in this part  
and the applicable provisions sections of R 333.5051 to R 333.5089, registration  
conditions, and the registrant's operating and emergency procedures, and has  
demonstrated an understanding of these subjects.  
(c) The individual demonstrated competence to use the radiation machine and survey  
instruments which will be employed in his or her assignment.  
(2) A registrant shall not permit an individual to act as a radiographer's assistant until  
both of the following have been met:  
(a) The individual received copies of and instruction in the registrant's operating and  
emergency procedures, and has demonstrated an understanding of these procedures.  
(b) The individual demonstrated competence to use, under the personal supervision of  
the radiographer, the radiation machines and radiation survey instruments which will be  
employed in his or her assignment.  
History: 2016 AACS.  
PART 7. MEDICAL X-RAY INSTALLATIONS  
R 333.5311 Purpose and scope.  
Rule 311. (1) This part establishes requirements governing the use of x-radiation in  
medicine, osteopathy, chiropractic, and podiatry.  
(2) This part applies to all registrants who use x-radiation as a health practitioner or  
on behalf of a health practitioner licensed under article 15 of the act for the intentional  
exposure of humans.  
(3) In addition to the requirements of this part, all registrants who use x-radiation as a  
health practitioner or on behalf of a health practitioner licensed under article 15 of the act  
are subject to all applicable provisions of these rules.  
History: 2016 AACS.  
THERAPEUTIC MACHINES OPERATED ABOVE 85 KVP  
R 333.5312 X-ray equipment.  
Rule 312. (1) The tube housing shall be of the therapeutic type.  
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(2) Permanent diaphragms or cones used for collimating the useful beam shall afford  
the same degree of attenuation as is required of the housing.  
(3) Adjustable or removable beam-limiting devices shall transmit not more than 5%  
of the useful beam as determined at the maximum tube potential and with maximum  
treatment filter.  
(4) Filters shall be so mounted as to prevent their movement during the treatment.  
(5) The filter slot shall be so constructed that the radiation escaping through it does  
not produce an exposure rate exceeding 1 R/h at 1 meter, or if the patient is likely to be  
exposed to radiation escaping from the slot, 30 R/h at 5 centimeters (2 inches) from the  
external opening.  
(6) A removable filter shall be permanently marked with its thickness and material.  
(7) A filter indication system shall be used on therapy machines which use  
changeable filters. It shall indicate, from the control panel, the presence or absence of a  
filter and it shall be designed to permit easy recognition of the filter in place.  
(8) The x-ray tube shall be so mounted that it cannot turn or slide with respect to the  
housing aperture. A reproducible means of measuring the focal spot to patient distance  
shall be provided.  
(9) Means to immobilize the tube housing during stationary portal treatment shall be  
provided.  
(10) An easily discernible indicator which shows whether or not x-rays are being  
produced shall be on the control panel.  
(11) Beam monitoring devices shall be fixed in the useful beam to indicate an error  
due to incorrect filter, tube current, or tube potential, unless the device introduces more  
filtration than is clinically acceptable.  
(12) A suitable exposure control device, such as an automatic timer, exposure meter,  
or dose meter, shall be provided to terminate the exposure after a preset time interval or  
preset exposure or dose limit. If a timer is used, it shall permit accurate presetting and  
determination of exposure times as short as 1 second. Means for the operator to  
terminate the exposure at any time shall be provided.  
(13) Mechanical or electrical stops, or both shall be provided to insure that the useful  
beam is oriented only toward primary barriers.  
(14) Interlocks shall be provided so that, when a door to the treatment room is  
opened, the machine turns off automatically or the radiation level within the room is  
reduced to an average of not more than 2 mR/h and a maximum of 10 mR/h at a distance  
of 1 meter in any direction from the source. After the shut-off or reduction in exposure  
rate, it shall be possible to restore the machine to full operation only from the control  
panel.  
(15) The x-ray control circuit shall be so designed that it is not possible to energize  
the x-ray tube to produce x-rays without resetting the x-ray "ON-OFF" switch at the  
control panel.  
(16) When the relationship between the beam interceptor (when present) and the  
useful beam is not permanently fixed, mechanical or electrical stops shall be provided to  
ensure that the beam is oriented only toward primary barriers.  
(17) X-ray machines with electron beam extraction capability shall be provided with  
such additional safety devices as determined necessary and specified in writing by the  
department to prevent accidental electron beam exposure.  
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(18) To reduce the electron contamination of high energy treatment beams, shadow  
trays, or other accessories placed in the primary beam shall be placed at a sufficient  
distance from the patient that the electron contamination contribution to the skin dose is  
minimal.  
History: 2016 AACS.  
Editor's Note: An obvious error in R 325.5312 was corrected at the request of the promulgating  
agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL 24.256. The rule  
containing the error was published in Michigan Register, 2016 MR 10. The memorandum requesting the  
correction was published in Michigan Register, 2016 MR 16.  
R 333.5315 Enclosures.  
Rule 315. (1) An enclosure shall be a permanent part of the building or equipment.  
Portable protective barriers shall not be used for permanent installations.  
(2) The degree of protection required for an enclosure shall be determined by the  
workload, use and occupancy factors, and the tube potential, tube current, mechanical  
movement, and distance. The design shall be subject to approval by the department.  
(3) All wall, ceiling, and floor areas that can be irradiated by the useful beam plus an  
additional area extending at least 30 centimeters (1 foot) beyond shall be provided with a  
primary protective barrier.  
(4) For equipment capable of operating above 150 kVp, the control station shall be  
outside of the therapy room.  
(5) The enclosure shall be so constructed that individuals may at all times be able to  
escape from within.  
(6) If the radiation exposure rate within the therapy room is so high that an individual  
who is accidentally in the treatment room when the machine is turned "ON" may receive  
as much as 1250 mR exposure during the time required to reach an access door, special  
cut-off, or panic buttons shall be required. When pressed, these buttons, operable by  
open hand at appropriate positions about the treatment room, shall cause the irradiation to  
be terminated.  
(7) Effective means shall be provided to prevent access to the treatment room during  
exposure. For equipment capable of operating above 150 kVp, each access door to the  
treatment room shall be provided with a fail-safe interlock. The interlock system shall be  
so designed that the failure of any 1 component cannot jeopardize the safety of the  
system, such as the use of series connected double switch assemblies at access doors, and  
dual interlock relays. If an access door is opened when the machine is "ON", the  
interlock shall cause termination or reduction of exposure as specified in R 333.5312(14).  
(8) Red warning signal lights, energized only when the useful beam in "ON", shall be  
located on the control panel and near each entrance to the therapy room. Under  
conditions as specified in subrule (6) of this rule a visible signal shall also be located  
within the therapy room. Depending upon control panel and door locations, a single  
warning signal light may be sufficient to comply with this subrule.  
History: 2016 AACS.  
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R 333.5317 Conditions of operation.  
Rule 317. (1) An installation shall be operated in compliance with all limitations  
determined necessary and specified in writing by the department.  
(2) The output of the x-ray generator shall be calibrated before use for the treatment  
of patients for each technique or condition of use. The department shall be informed by  
telephone or in writing of completion of initial calibration before patient treatment is  
initiated. A written report of this initial calibration shall be submitted within 30 days to  
the department. Recalibration shall be required after each tube replacement and after any  
changes or replacement in the generating apparatus which could affect a change in the x-  
ray output. Check calibrations shall be made on an annual basis and records of all  
calibration maintained for not less than 7 years.  
(3) X-ray therapy equipment capable of operating above 150 kVp shall not be  
operated routinely until the radiation safety of the installation has been established by a  
protection survey conducted pursuant to R 333.5063. The department shall be informed  
by telephone or in writing of completion of the initial survey before patient treatment is  
initiated. A written report of this initial survey shall be submitted within 30 days to the  
department. All x-ray therapy equipment shall be operated in conformance with  
recommendations of the protection survey.  
(4) Both the control panel and the patient shall be observable during exposure.  
(5) When a patient must be held in position for radiation therapy, mechanical  
supporting or restraining devices should be used. If the patient must be held by an  
individual, upon approval by the radiologist in charge followed by written notice to the  
department, that individual shall be provided protection equivalent to 7 half-value layers  
and shall be positioned so that no part of his or her body can be struck by the useful beam  
and is as far as possible from the edge of the useful beam. The exposure of an individual  
used for this purpose shall be monitored and a permanent record maintained. The  
individual selected for this purpose shall not otherwise be occupationally exposed to  
ionizing radiation.  
(6) With the exception of subrule (5) of this rule, an individual other than the patient  
shall not be permitted in the treatment room when the tube is operated at potentials  
exceeding 85 kVp. At potentials of 85 kVp or below, other individuals may be permitted  
in the treatment room by the radiologist in charge if they are essential to conduct the  
treatment, but only if they are protected as specified in subrule (5) of this rule and their  
radiation exposure is monitored and permanently recorded.  
(7) Personnel monitoring shall be performed in controlled areas for each individual  
occupationally exposed to ionizing radiation from therapeutic x-ray equipment.  
Individual monitoring devices, such as film badge dosimeters or thermoluminescent  
dosimeters, shall be permanently assigned to each occupationally exposed individual.  
This monitoring shall be continuous during employment as a radiation worker.  
(8) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs.  
(9) Monitoring devices used to estimate whole body exposure shall normally be worn  
on the chest or abdomen. Monitoring of other body parts shall comply with R 333.5065.  
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(10) Monitoring devices worn to estimate personnel occupational exposure shall not  
be worn by the individual when he or she is exposed as a patient for a medical or dental  
reason.  
(11) Lead, lead rubber, lead foil, and similar materials used for limiting the field shall  
not transmit more than 5% of the useful beam under the conditions at which the machine  
is operated for therapy. This subrule does not apply to treatment blocks used to adjust or  
modify the intended radiation dose to the area of treatment.  
(12) A therapeutic x-ray system shall not be left unattended without locking the  
apparatus, room, or building in some manner which prevents use of the apparatus by  
unauthorized persons.  
History: 2016 AACS.  
THERAPEUTIC MACHINES OPERATED AT OR BELOW 85 KVP  
R 333.5321 X-ray equipment.  
Rule 321. (1) The x-ray equipment shall comply with the requirements of  
R 333.5312, excluding subrules (11), (14), and (16).  
(2) Maximum potential shall be mechanically or electronically limited to 85 kVp.  
(3) A contact therapy machine shall meet the additional requirement that the leakage  
radiation at 5 centimeters (2 inches) from the surface of the tube housing shall not exceed  
0.1 R/h. As used in this subrule, "contact therapy machine" means an x-ray therapy  
machine designed for source to skin treatment distances of 5 centimeters or less at tube  
potentials in the range of 20 to 50 kVp.  
History: 2016 AACS.  
R 333.5322 Enclosures.  
Rule 322. An enclosure shall comply with the requirements of R 333.5315(1) and (2).  
History: 2016 AACS.  
R 333.5323 Conditions of operation.  
Rule 323. (1) Operation shall comply with the requirements of R 333.5317.  
(2) If the x-ray tube of a contact therapy machine as defined in R 333.5321(3) is hand  
held during irradiation, the operator shall wear protective gloves and a protective apron.  
When practical, a cap of at least 0.5 millimeter lead equivalence should cover the  
aperture window of the tube housing of the apparatus when not being used. Because the  
exposure rate at the surface of the window of contact therapy and beryllium window  
machines may be more than 10,000 roentgens per minute, extreme precautions shall be  
taken to prevent accidental exposure to the useful beam.  
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History: 2016 AACS.  
FIXED RADIOGRAPHIC INSTALLATIONS  
R 333.5325 X-ray equipment.  
Rule 325. (1) All x-ray tube housings in fixed radiographic installations shall be of  
the diagnostic type.  
(2) The aluminum equivalent of the total filtration in the useful beam shall not be less  
than the values shown in table 325-1.  
TABLE 325-1  
Operating Potential  
Minimum Total Filter  
(Inherent plus added)  
Below 50 kVp  
50-70 kVp  
Above 70 kVp  
0.5 mm aluminum  
1.5 mm aluminum  
2.5 mm aluminum  
(3) If the filter in the machine is not accessible for examination and the total filtration  
is not known, subrule (2) of this rule may be assumed to have been met if the half-value  
layer is not less than any of the following:  
(a) 0.6 mm aluminum at 49 kVp.  
(b) 1.6 mm aluminum at 70 kVp.  
(c) 2.6 mm aluminum at 90 kVp.  
(4) Under conditions of subrule (3) of this rule for tube potentials above 90 kVp,  
subrule (2) of this rule may be assumed to have been met if the half-value layer is not less  
than that specified in table 325-2.  
(5) The half-value layer of the useful beam for a given x-ray tube potential shall not  
be less than the values shown in table 325-2.  
TABLE 325-2  
Measured  
Potential  
(kVp)  
Half-value  
Layer  
(mm aluminum)  
Design Operating Range  
(kVp)  
Below 50  
50 to 70  
30  
40  
49  
50  
60  
70  
0.3  
0.4  
0.5  
1.2  
1.3  
1.5  
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Above 70  
80  
2.3  
2.5  
2.7  
3.0  
3.2  
3.5  
3.8  
4.1  
90  
100  
110  
120  
130  
140  
150  
(6) To determine the half-value layer at an x-ray tube potential which is not listed in  
table 325-2, linear interpolation or extrapolation may be made. Positive means shall be  
provided to ensure that at least the minimum filtration needed to achieve these beam  
quality requirements is in the useful beam during each exposure.  
(7) Machines equipped with beryllium window x-ray tubes with removable filters  
shall contain keyed filter interlock switches in the tube housing and suitable indication on  
the control panel of the added filter in the useful beam. The total filtration permanently  
in the useful beam shall not be less than 0.5 millimeter aluminum equivalent and shall be  
clearly indicated on the tube housing.  
(8) Beryllium window x-ray tubes shall not be used routinely for general purpose  
diagnostic examinations. Such a tube may comprise an x-ray subsystem if needed for  
special soft tissue technique in accord with subrule (7) of this rule.  
(9) Beam-limiting devices, such as diaphragms, cones, or adjustable collimators,  
capable of restricting the useful beam to the area radiographically recorded shall be  
provided to define the beam and shall provide the same degree of attenuation as that  
required of the tube housing.  
(10) Beam-limiting devices shall be calibrated in terms of the size of the projected  
useful beam at specified source-image receptor distances (SID). This calibration shall be  
clearly and permanently recorded on the beam-limiting device. Calibration of adjustable  
beam-limiting devices shall permit reproducible settings.  
(11) X-ray systems designed for only 1 image receptor size at a fixed SID shall be  
provided with means to limit the field at the plane of the image receptor to dimensions no  
greater than those of the image receptor, and to align the center of the x-ray field with the  
center of the image receptor to within 2% of the SID.  
(12) General purpose radiographic x-ray systems shall be equipped with adjustable  
beam-limiting devices containing light localizers that define the entire field.  
(13) The size of the x-ray beam projected by fixed aperture beam-limiting devices,  
except those used for stereoradiography, shall not exceed the dimensions of the image  
receptor by more than 2% of the SID when the axis of the x-ray beam is perpendicular to  
the plane of the image receptor.  
(14) The calibrated field size indicator on adjustable beam-limiting devices shall be  
accurate to within 2% of the SID. The light field shall be aligned with the x-ray field  
with the same degree of accuracy. The field size projected by automatic adjustable  
beam-limiting devices shall provide the same precision.  
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(15) For radiographic procedures resulting in multiple views on a single image  
receptor, the beam-limiting device shall limit the x-ray field size to the recorded  
radiographic image size within 2% of the SID. Covering a portion of the image receptor  
with radio-opaque material is not a substitute for proper x-ray field limitation.  
(16) Radiographic x-ray machines used for purposes other than mammography or  
extremity radiography only shall be capable of operation at not less than an average  
current of 100 milliamperes (mA) during all radiographic techniques used. A machine  
not capable of sustained operation at not less than an average of 100 mA for the duration  
of a given technique shall not be used for that technique.  
(17) A device shall be provided which terminates the exposure at a preset time  
interval or exposure limit. The operator shall be able to terminate the exposure at any  
time by discontinuing pressure upon the exposure switch except that during serial  
radiography means may be provided to permit completion of a single exposure in  
progress.  
(18) The exposure switch, except for those used in conjunction with spot film devices  
in fluoroscopy, shall be securely fixed so that the operator is required to be behind a fixed  
shield which intercepts the useful beam and any radiation which has been scattered only  
once.  
(19) When 2 or more x-ray tube heads are operated from a single exposure switch,  
there shall be indication at the control panel showing which tube is connected and ready  
to be energized and means to prevent energizing more than 1 tube head simultaneously.  
Machines designed for simultaneous multiple tube operation shall have positive means  
for selecting single tube or multiple tube operation.  
(20) The control panel shall provide positive visual identification of the production of  
x-rays when the x-ray tube is energized. A milliammeter may comply with this subrule.  
(21) A signal audible to the operator shall indicate that the exposure has ended.  
(22) The technique factors to be used during an exposure shall be indicated before the  
exposure begins. When automatic exposure controls are used, only those technique  
factors which are set before the exposure shall be indicated. On equipment having fixed  
technique factors, this requirement may be met by permanent markings. Indication of  
technique factors shall be visible from the operator's position.  
History: 2016 AACS.  
R 333.5331 Enclosures.  
Rule 331. (1) An enclosure shall be a permanent part of the building or equipment.  
Portable shields shall not be used for permanent installations.  
(2) The degree of protection required for an enclosure shall be determined by the  
workload, use and occupancy factors, and the tube potential, tube current, mechanical  
movement, and distance. The design shall be subject to approval by the department.  
Recommended shielding is posted on the department’s website.  
(3) In a radiographic room, wall and floor areas exposed to the useful beam plus an  
additional area extending at least 30 centimeters (1 foot) beyond shall be provided with a  
primary protective barrier as determined by workload, use and occupancy factors, and  
distance. All vertical primary protective barriers specified in this rule shall extend  
continuously from the floor to a minimum height of 2.1 meters (7 feet).  
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(4) Secondary protective barriers shall be provided in the radiographic room ceiling  
and in those walls not requiring primary barriers.  
(5) Control apparatus for the radiographic equipment shall be shielded by a primary  
protective barrier which cannot be removed from a protective position between the  
operator and the radiation source during machine operation.  
(6) Movable barriers with electrical interlocks shall not be approved in place of  
compliance with subrule (5) of this rule.  
(7) Exposure switch location and control shield shall be oriented so that, at arm's  
length from the exposure switch, the operator is not exposed to the useful beam, leakage  
radiation, or any radiation scattered only once.  
(8) The operator shall be able to see and communicate with the patient from a  
shielded position at the control panel. When an observation window is provided, it shall  
have a lead equivalence at least equal to that required of the control barrier and shall be  
installed so that the attenuation effectiveness of the barrier is not impaired.  
(9) At times it may be necessary for personnel to remain within an operating room or  
special procedure installation during radiographic exposures. A primary protective  
barrier shall be provided for personnel protection under these circumstances unless  
necessary technique prevents use of such protection. This barrier may be movable if  
necessary. Movable barriers shall not be permitted in place of the provisions of subrules  
(3) and (5) of this rule.  
History: 2016 AACS.  
R 333.5333 Conditions of operation.  
Rule 333. (1) An operator shall properly utilize the beam-limiting devices provided to  
restrict the useful beam to the smallest area consistent with clinical requirements.  
Particular care shall be taken to align accurately the x-ray beam with the patient and film.  
(2) The operator shall ensure the presence of adequate filtration before a radiographic  
procedure.  
(3) Staff personnel routinely working with or around radiation sources shall not be  
required by the registrant to hold film or restrain patients during radiography. If such  
procedure is permitted, personnel exposure shall not exceed the limits in R 333.5057 to  
R 333.5059 or the procedure shall be prohibited.  
(4) When a patient must be held in position for radiography, mechanical supporting or  
restraining devices shall be available and shall be used unless contraindicated. If the  
patient must be held by an individual, this individual shall wear protective gloves and a  
protective apron of 0.5 millimeter minimum lead equivalence and shall be positioned so  
that no part of his or her body can be struck by the useful beam and that his or her body is  
as far as possible from the edge of the useful beam.  
(5) Only individuals whose presence is necessary shall be permitted in the  
radiographic room during an exposure. An individual, except the patient, shall be  
protected by 0.5 millimeter minimum lead equivalent aprons unless protected by an  
approved primary barrier.  
(6) Personnel monitoring shall be performed in controlled areas for each individual  
occupationally exposed to ionizing radiation from diagnostic x-ray equipment.  
Individual monitoring devices such as film badge dosimeters or thermoluminescent  
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dosimeters shall be permanently assigned to each occupationally exposed individual.  
This monitoring shall be continuous during employment as a radiation worker.  
(7) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs.  
(8) Monitoring devices used to estimate whole body exposure shall normally be worn  
on the chest or abdomen. Monitoring of all other body parts shall comply with  
R 333.5065.  
(9) Monitoring devices worn to estimate personnel occupational exposure shall not be  
worn by the individual when he or she is exposed as a patient for a medical or dental  
reason.  
(10) The gonads of children and individuals who have not passed the reproductive  
age shall be protected from the useful beam either by the use of shielding (0.5 mm lead  
equivalent), collimation, or special gonad shields when this does not interfere with the  
conditions or objectives of the examination.  
(11) Intensifying screens shall be employed to reduce patient exposure except in cases  
where a noticeable decrease in image definition may reduce the clinical value of the  
examination. Film and screen speed combinations shall be carefully selected to produce  
the necessary clinical information with the least exposure to the patient consistent with  
current clinical judgment.  
(12) Film processing materials and techniques shall be those recommended by the x-  
ray film and processing materials manufacturers unless otherwise tested to ensure  
maximum information content of the developed film. Sight developing is not permitted  
except under extreme emergency conditions.  
development time shall be used.  
Correct temperature control and  
(13) A radiographic x-ray system shall not be left unattended without locking the  
apparatus, room, or building in some manner which prevents use of the apparatus by  
unauthorized persons.  
History: 2016 AACS.  
FIXED FLUOROSCOPIC INSTALLATIONS  
R 333.5337 X-ray equipment.  
Rule 337. (1) All x-ray tube housings of fixed fluoroscopic installations shall be of  
the diagnostic type.  
(2) The beam quality shall comply with the provisions of R 333.5325(5) and  
R 333.5325(6).  
(3) Means shall be provided on all fluoroscopic machines to limit the source-skin  
distance to not less than 38 centimeters. For image intensified fluoroscopes intended for  
specific surgical application that would be prohibited at this source-skin distance,  
provisions may be made for operation at shorter distances but in no case less than 20  
centimeters.  
(4) Provision shall be made to intercept the scattered x-rays from the undersurface of  
the table top and other structures under the fluoroscopic table if the tube is mounted  
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under the table. A cone or shield shall provide the same degree of attenuation as is  
required of the tube housing.  
(5) A shielding device of at least 0.25 millimeter lead equivalence for covering the  
bucky slot during fluoroscopy shall be provided.  
(6) A shielding device of at least 0.25 millimeter lead equivalence, such as  
overlapping protective drapes or hinged or sliding panels, shall be used to intercept  
scattered radiation which would otherwise reach the fluoroscopist and others near the  
machine.  
(7) The equipment shall be so constructed that, under conditions of normal use, the  
entire cross section of the useful beam is attenuated by a primary protective barrier,  
permanently incorporated into the equipment. The exposure shall automatically  
terminate when the barrier is removed from the useful beam.  
(8) A fluoroscopic machine shall comply with both of the following:  
(a) The entire cross section of the useful beam shall be intercepted by the primary  
protective barrier of the fluoroscopic image assembly at any SID. The fluoroscopic tube  
shall not produce x-rays unless the barrier is in position to intercept the entire useful  
beam. The exposure rate due to transmission through the barrier with the attenuation  
block in the useful beam combined with radiation from the image intensifier, if provided,  
shall not exceed 2 milliroentgens per hour at 10 centimeters from any accessible surface  
of the fluoroscopic imaging assembly beyond the plane of the image receptor for each  
roentgen per minute of entrance exposure rate.  
(b) The entrance exposure rate shall be measured pursuant to subrule (16) of this rule.  
The exposure rate due to transmission through the primary barrier combined with  
radiation from the image intensifier shall be determined by measurements averaged over  
an area of 100 square centimeters with no linear dimension greater than 20 centimeters.  
If the source is below the tabletop, the measurement shall be made with the input surface  
of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop. If  
the source is above the tabletop and the SID is variable, the measurement shall be made  
with the end of the beam-limiting device or spacer as close to the tabletop as it can be  
placed, if it is not closer than 30 centimeters. Movable grids and compression devices  
shall be removed from the useful beam during the measurement. For all measurements,  
the attenuation block shall be positioned in the useful beam 10 centimeters from the point  
of measurement of the entrance exposure rate and between this point and the input  
surface of the fluoroscopic imaging assembly.  
(9) The lead equivalence of the barrier of conventional fluoroscopes shall be not less  
than 1.5 millimeters at 100 kVp, 1.8 millimeters at 125 kVp, and 2.0 millimeters at  
potentials greater than 125 kVp.  
(10) A beam-limiting device shall be provided to restrict the size of the useful beam  
to less than the area of the barrier. The x-ray tube and beam-limiting system shall be  
linked with the fluorescent screen assembly so that the useful beam at the fluorescent  
screen is confined within the barrier irrespective of the panel-screen distance. For image  
intensifiers, the useful beam shall be centered on the input phosphor. It should not  
exceed the diameter of the input phosphor during fluoroscopy or cine-recording. For spot  
film radiography with image intensifier equipment, the shutters should automatically  
open to the required field size before the exposure.  
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(11) Beam-limiting devices such as collimators, adjustable diaphragms, or shutters,  
shall provide the same degree of attenuation as is required of the tube housing.  
(12) A fluoroscopic machine shall comply with either of the following:  
(a) The x-ray field produced by nonimage-intensified fluoroscopic equipment shall  
not extend beyond the entire visible area of the image receptor. Means shall be provided  
to permit further limitation of the field. The minimum field size at the greatest SID shall  
be equal to or less than 5 by 5 centimeters.  
(b) For image-intensified fluoroscopic equipment, the total misalignment of the edges  
of the x-ray field with the respective edges of the visible area of the image receptor along  
any dimension of the visually defined field in the plane of the image receptor shall not  
exceed 3% of the SID. The sum, without regard to sign, of the misalignment along any 2  
orthogonal dimensions intersecting at the center of the visible area of the image receptor  
shall not exceed 4% of the SID. For rectangular x-ray fields used with circular image  
receptors, the error in alignment shall be determined along the length and width  
dimensions of the x-ray field which pass through the center of the visible area of the  
image receptor. Means shall be provided to permit further limitation of the field. The  
minimum field size, at the greatest SID, shall be equal to or less than 5 by 5 centimeters.  
(13) X-ray production in the fluoroscopic mode shall be controlled by a device which  
requires continuous pressure by the operator for the entire time of an exposure. When  
recording serial fluoroscopic images, the operator shall be able to terminate the x-ray  
exposures at any time, but means may be provided to permit completion of any single  
exposure of the series in progress.  
(14) When the fluoroscope is operated at 80 kVp, the exposure rate at the position  
where the beam enters the patient shall not exceed 3.2 R/mA-min and should not exceed  
2.1 R/mA-min.  
(15) Entrance exposure rate limits for fluoroscopic equipment shall be as follows:  
(a) Machines with automatic exposure rate control shall not be operable at a  
combination of tube potential and current which results in an a exposure rate in excess of  
10 roentgens per minute at the point where the center of the useful beam enters the  
patient, except during recording of fluoroscopic images or when an optional high level  
control is provided.  
Special means of activation of high level controls, such as  
additional pressure applied continuously by the operator, shall be required to avoid  
accidental use. A continuous signal audible to the fluoroscopist shall indicate that the  
high level control is being employed.  
(b) Machines without automatic exposure rate control shall not be operable at a  
combination of tube potential and current which results in an exposure rate in excess of 5  
roentgens per minute at the point where the center of the useful beam enters the patient,  
except during recording of fluoroscopic images or when an optional high level control is  
activated. Special means of activation of high level controls, such as additional pressure  
applied continuously by the operator, shall be provided to avoid accidental use. A  
continuous signal audible to the fluoroscopist shall indicate that the high level control is  
being employed.  
(16) Compliance with subrule (15) of this rule shall be determined as follows:  
(a) If the source is below the table, the exposure rate shall be measured 1 centimeter  
above the tabletop or cradle.  
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(b) If the source is above the table, the exposure rate shall be measured at 30  
centimeters above the tabletop with the end of the beam-limiting device or spacer  
positioned as closely as possible to the point of measurement.  
(c) In a C-arm type of fluoroscope, the exposure rate shall be measured 30  
centimeters from the input surface of the fluoroscopic imaging assembly.  
(17) Means shall be provided to present the cumulative on-time of the fluoroscopic  
tube. The maximum cumulative time of the timing device shall not exceed 5 minutes  
without resetting. A signal audible to the fluoroscopist shall indicate the completion of a  
preset cumulative on-time. This signal shall continue to sound while x-rays are produced  
until the timing device is reset.  
(18) Devices which indicate the x-ray tube potential and current shall be provided.  
On image intensified fluoroscopic equipment, these devices should be located in such a  
manner that the operator may monitor the tube potential and current during fluoroscopy.  
History: 2016 AACS.  
R 333.5347 Enclosures.  
Rule 347. (1) An enclosure shall be a permanent part of the building or equipment.  
Portable shields shall not be used for permanent installations.  
(2) The degree of protection required for an enclosure shall be determined by the  
workload, use and occupancy factors, and the tube potential, tube current, mechanical  
movement, and distance, and shall be subject to design approval by the department.  
Recommended shielding is posted on the department’s website.  
(3) For conventional fluoroscopy, extraneous light that interferes with the  
fluoroscopic examination shall be eliminated. Dark adaptation normally is not necessary  
when using image intensifiers.  
History: 2016 AACS.  
R 333.5348 Conditions of operation.  
Rule 348. (1) An individual present in a fluoroscopic room, except the patient, shall  
wear a protective apron of at least 0.5 millimeter lead equivalence.  
(2) Only individuals whose presence is needed to conduct the examination, to conduct  
radiation protection surveys, or to undergo specific training shall be permitted in the  
fluoroscopy room during x-ray exposures.  
(3) Personnel monitoring shall be performed in controlled areas for each individual  
occupationally exposed to ionizing radiation from diagnostic x-ray equipment.  
Individual monitoring devices, such as film badge dosimeters or thermoluminescent  
dosimeters, shall be permanently assigned to each occupationally exposed individual.  
This monitoring shall be continuous during employment as a radiation worker.  
(4) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs.  
(5) Monitoring devices used to estimate whole body exposure shall normally be worn  
on the chest or abdomen. Monitoring of all other body parts shall comply with  
R 333.5065.  
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(6) Monitoring devices worn to estimate personnel occupational exposure shall not be  
worn by the individual when he or she is exposed as a patient for a medical or dental  
reason.  
(7) The fluoroscopist's eyes should be sufficiently dark-adapted for the visual task  
required before commencing conventional fluoroscopy. Under no circumstances shall he  
or she attempt to compensate for inadequate adaptation by increasing exposure factors  
employed or by prolonging the fluoroscopic examination.  
(8) Special precautions, consistent with clinical needs, shall be taken to minimize  
exposure of the gonads of potentially procreative patients and exposure of the embryo or  
fetus in patients known to be or suspected of being pregnant. Gonadal shielding is  
advised when it does not interfere with the conditions or objectives of the examination.  
(9) In cineradiography, special care shall be taken to limit patient exposure when tube  
currents and potentials employed are higher than those normally used in fluoroscopy.  
The exposure rates to which patients are normally subjected shall be determined annually  
and records of the surveys maintained.  
(10) A fluoroscopic x-ray system shall not be left unattended without locking the  
apparatus, room, or building in some manner which prevents use of the apparatus by  
unauthorized persons.  
History: 2016 AACS.  
MOBILE OR PORTABLE DIAGNOSTIC X-RAY EQUIPMENT  
R 333.5351 X-ray equipment.  
Rule 351. (1) Radiographic x-ray equipment shall comply with the requirements of  
R 333.5325 excluding subrules (11) and (18).  
(2) Fluoroscopic x-ray equipment shall comply with the requirements of R 333.5337  
excluding subrules (3), (4), (5), (6), and (9).  
(3) The radiographic exposure control switch shall be located on the machine where  
adequate personnel protection is provided to attenuate the direct and scatter radiation, or  
the length of switch cord shall be such that the operator shall be able to stand at least 1.8  
meters (6 feet) from the patient, the x-ray tube, and out of the useful beam. A coil type  
extension switch cord capable of providing more than 1.8 meters (6 feet) of distance  
protection is recommended.  
(4) Hand-held fluoroscopic screens and others not attached to a diagnostic source  
assembly with stable mounting shall not be used.  
(5) Image intensification shall always be provided on mobile fluoroscopic equipment.  
Mobile fluoroscopic equipment shall be impossible to operate unless the useful beam is  
intercepted by the image intensifier. Means shall be provided to limit the source-skin  
distance to not less than 30 centimeters (12 inches). For fluoroscopes intended for  
specific surgical application that would be prohibited at the source-skin distances  
specified in this subrule, provisions may be made for operation at shorter source-skin  
distances but in no case less than 20 centimeters.  
History: 2016 AACS.  
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R 333.5352 Shielding.  
Rule 352. (1) Portable shielding of at least 1.6 millimeter (1/16 inch) lead equivalent  
shall be used by the operator and other individuals in the room when possible.  
(2) Mobile or portable diagnostic x-ray equipment used routinely in 1 location shall  
be considered a fixed installation and shall comply with the requirements of R 333.5325  
and R 333.5331, or R 333.5337 and R 333.5347, or both.  
History: 2016 AACS.  
R 333.5353 Conditions of operation.  
Rule 353. (1) Operation shall comply with the requirements of R 333.5333 and  
R 333.5348.  
(2) Individuals operating mobile or portable diagnostic x-ray equipment shall wear a  
protective apron of minimum 0.5 millimeter lead equivalence unless portable shielding is  
provided as specified in R 333.5352(1).  
(3) Mobile or portable diagnostic x-ray equipment shall not be used for routine  
radiography or fluoroscopy in hospitals or private offices of health practitioners licensed  
under article 15 of the act. This equipment shall only be used when it is medically  
inadvisable to move a patient to a fixed radiographic or fixed fluoroscopic installation.  
History: 2016 AACS.  
MISCELLANEOUS AND SPECIAL INSTALLATIONS  
R 333.5355 General provisions.  
Rule 355. (1) Types of x-ray sources and uses not specifically covered by this part  
and not exempted in R 333.5033, shall comply with R 333.5001 to R 333.5101.  
(2) For the purpose of registering and approving medical x-ray producing equipment  
and devices not specifically covered by this part the protective design, the workload, the  
use factor, and the occupancy factor shall be considered.  
History: 2016 AACS.  
PART 8. MEDICAL EXTREMITY X-RAY INSTALLATIONS  
R 333.5361 Purpose and scope.  
Rule 361. (1) This part establishes requirements governing the use of x-radiation in a  
healing arts discipline for human extremity radiography only.  
(2) This part applies to all registrants who use x-radiation for the intentional exposure  
of human extremities only.  
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(3) In addition to the requirements of this part, all registrants performing human  
extremity radiography are subject to all applicable provisions of these rules. Uses of x-  
radiation for intentional human exposure other than or in addition to extremity  
radiography are subject to R 333.5311 to R 333.5359.  
History: 2016 AACS.  
FIXED RADIOGRAPHIC INSTALLATIONS  
R 333.5362 X-ray equipment.  
Rule 362. (1) All x-ray tube housings in fixed radiographic installations shall be of  
the diagnostic type.  
(2) The aluminum equivalent of the total filtration in the useful beam shall not be less  
than that shown in table 362.  
TABLE 362  
Operating Potential  
Minimum Total Filter  
(Inherent plus added)  
0.5 mm aluminum  
Below 50 kVp  
50-70 kVp  
1.5 mm aluminum  
Above 70 kVp  
2.5 mm aluminum  
(3) If the filter in the machine is not accessible for examination and the total filtration  
is not known, subrule (2) of this rule may be assumed to have been met if the half-value  
layer is not less than any of the following:  
(a) 0.6 mm aluminum at 49 kVp.  
(b) 1.6 mm aluminum at 70 kVp.  
(c) 2.6 mm aluminum at 90 kVp.  
(4) Under conditions of subrule (3) of this rule, for tube potentials above 90 kVp,  
subrule (2) of this rule may be assumed to have been met if the half-value layer is not less  
than that specified in table 325-2 in R 333.5325(5).  
(5) Beam-limiting devices, such as diaphragms, cones, or adjustable collimators,  
capable of restricting the useful beam to the area radiographically recorded shall be  
provided to define the beam and shall provide the same degree of attenuation as that  
required of the tube housing.  
(6) Beam-limiting devices shall be calibrated in terms of the size of the projected  
useful beam at specified source-image receptor distances (SID). The calibration shall be  
clearly and permanently recorded on the beam-limiting device. Calibration of adjustable  
beam-limiting devices shall permit reproducible settings.  
(7) X-ray systems designed for only 1 image receptor size at a fixed SID shall be  
provided with means to limit the field at the plane of the image receptor to dimensions no  
greater than those of the image receptor, and to align the center of the x-ray field with the  
center of the image receptor to within 2% of the SID.  
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(8) The size of the x-ray beam projected by fixed aperture beam-limiting devices,  
except those used for stereoradiography, shall not exceed the dimensions of the image  
receptor by more than 2% of the SID when the axis of the x-ray beam is perpendicular to  
the plane of the image receptor.  
(9) The calibrated field size indicator on adjustable beam-limiting devices shall be  
accurate to within 2% of the SID. The light field shall be aligned with the x-ray field  
with the same degree of accuracy. The field size projected by automatic adjustable  
collimators shall provide the same precision.  
(10) For radiographic procedures resulting in multiple views on a single image  
receptor, the beam-limiting device shall limit the x-ray field size to the recorded  
radiographic image size within 2% of the SID. Covering a portion of the image receptor  
with radio-opaque material is not a substitute for proper x-ray field limitation.  
(11) A device shall be provided to terminate the exposure at a preset time interval or  
exposure limit. The operator shall be able to terminate the exposure at any time by  
discontinuing pressure upon the exposure switch.  
(12) Unless protective shielding is provided for the operator, the length of the  
exposure control switch cord or remote control location shall be such that the operator  
shall be able to stand at least 1.8 meters (6 feet) away from the patient and the x-ray tube  
and out of the useful beam. When protective shielding is provided, the operator shall  
always be entirely behind the shield during the exposure.  
(13) The control panel shall provide positive identification of the production of x-rays  
when the x-ray tube is energized. A milliammeter may meet the requirements of this  
subrule.  
(14) The technique factors to be used during an exposure shall be indicated before the  
exposure begins. When automatic exposure controls are used, only those technique  
factors which are set before the exposure shall be indicated. On equipment having fixed  
technique factors, this requirement may be met by permanent markings. Indication of  
technique factors shall be visible from the operator's position.  
(15) A signal audible to the operator shall indicate that the exposure has ended.  
History: 2016 AACS.  
R 333.5365 Enclosures.  
Rule 365. (1) The degree of protection required for an enclosure shall be determined  
by the workload, use and occupancy factors, and the tube potential, tube current,  
mechanical movement, and distance, and shall be subject to design approval by the  
department.  
(2) In a radiographic room, wall and floor areas exposed to the useful beam plus an  
area extending at least 30 centimeters (1 foot) beyond shall be provided with a primary  
protective barrier where necessary as determined by workload, use and occupancy  
factors, and distance.  
(3) Secondary protective barriers shall be provided in the radiographic room ceiling  
and in those walls not requiring primary barriers. Common building materials often  
fulfill this requirement.  
(4) A fixed barrier of 1.6 millimeters (1/16 inch) lead equivalence, such as a shielded  
wall partition or immobilized portable shield, is recommended for operator protection.  
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When this protection is provided, the operator shall be able to see and communicate with  
the patient from a shielded position.  
History: 2016 AACS.  
R 333.5366 Conditions of operation.  
Rule 366. (1) An operator shall properly utilize the beam-limiting devices provided to  
restrict the useful beam to the smallest area consistent with clinical requirements.  
Particular care shall be taken to align accurately the x-ray beam with the patient and film.  
(2) The operator shall ensure the presence of adequate filtration before each  
radiographic procedure.  
(3) Staff personnel routinely working with or around radiation sources shall not be  
required by the registrant to hold film or restrain patients during radiography. If the  
procedure is permitted, personnel exposure shall not exceed the limits in R 333.5057 to  
R 333.5059 or the procedure shall be prohibited.  
(4) When a patient is held in position for radiography, mechanical supporting or  
restraining devices shall be available and shall be used unless contraindicated. If the  
patient is held by an individual, this individual shall wear protective gloves and a  
protective apron of 0.5 millimeter minimum lead equivalence and shall be positioned so  
that no part of his or her body can be struck by the useful beam and that his or her body is  
as far as possible from the edge of the useful beam.  
(5) During each exposure, the operator shall stand at least 1.8 meters (6 feet) from the  
patient and the x-ray tube and outside the useful beam or behind a suitable barrier.  
(6) Only individuals whose presence is necessary shall be permitted in the  
radiographic room during an exposure. An individual, except the patient, shall be  
protected by 0.5 millimeter minimum lead equivalent aprons unless protected by an  
approved primary barrier.  
(7) Personnel monitoring shall be performed in controlled areas for each individual  
occupationally exposed to ionizing radiation from diagnostic x-ray equipment.  
Individual monitoring devices, such as film badge dosimeters or thermoluminescent  
dosimeters, shall be permanently assigned to each occupationally exposed individual.  
This monitoring shall be continuous during employment as a radiation worker.  
(8) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs.  
(9) Monitoring devices used to estimate whole body exposure shall normally be worn  
on the chest or abdomen. Monitoring of all body parts shall comply with R 333.5065.  
(10) Monitoring devices worn to estimate personnel occupational exposure shall not  
be worn by the individual when he or she is exposed as a patient for a medical or dental  
reason.  
(11) The gonads of children and individuals who have not passed the reproductive  
age shall be protected from the useful beam either by the use of shielding (0.5 mm lead  
equivalent), collimation, or special gonad shields. Special gonadal aprons (0.25 mm lead  
equivalent) are recommended, but not required, for patient protection from secondary  
radiation.  
(12) Intensifying screens shall be employed to reduce patient exposure except in cases  
where a noticeable decrease in image definition may reduce the clinical value of the  
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examination. Film and screen speed combinations shall be carefully selected to produce  
the necessary clinical information with the least exposure to the patient consistent with  
current clinical judgment.  
(13) Film processing materials and techniques shall be those recommended by the x-  
ray film and processing materials manufacturers unless otherwise tested to insure  
maximum information content of the developed film. Sight developing is not permitted  
except under extreme emergency conditions.  
development time shall be used.  
Correct temperature control and  
(14) A radiographic x-ray system shall not be left unattended without locking the  
apparatus, room, or building in some manner which prevents use of the apparatus by  
unauthorized persons.  
History: 2016 AACS.  
MOBILE OR PORTABLE RADIOGRAPHIC EQUIPMENT  
R 333.5368 General provisions.  
Rule 368. (1) Radiographic x-ray equipment shall meet the requirements of  
R 333.5362.  
(2) Mobile or portable radiographic x-ray equipment used routinely in 1 location shall  
be considered a fixed installation and enclosures shall meet the requirements of  
R 333.5365.  
(3) Operation shall comply with the requirements of R 333.5366.  
History: 2016 AACS.  
PART 9. DENTAL X-RAY INSTALLATIONS  
R 333.5371 Purpose and scope.  
Rule 371. (1) This part establishes requirements governing the use of x-radiation in  
dentistry.  
(2) This part applies to all registrants who use x-radiation in dentistry for the  
intentional exposure of humans.  
(3) In addition to the requirements of this part all registrants are subject to all  
applicable provisions of these rules.  
History: 2016 AACS.  
CONVENTIONAL (SINGLE TUBE) INSTALLATIONS  
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R 333.5372 Scope.  
Rule 372. R 333.5373 to R 333.5376 apply to installations consisting of a single x-ray  
source, its individual control unit, and protective enclosure used for the production of  
intraoral radiographs.  
History: 2016 AACS.  
R 333.5373 X-ray equipment.  
Rule 373. (1) The tube housing shall be of the diagnostic type.  
(2) The aluminum equivalent of the total filtration in the useful beam shall not be less  
than that shown in table 373-1.  
TABLE 373-1  
Operating Potential  
Minimum Total Filter  
(Inherent plus added)  
0.5 mm aluminum  
1.5 mm aluminum  
2.5 mm aluminum  
Below 50 kVp  
50 - 70 kVp  
Above 70 kVp  
(3) If the filter in the machine is not accessible for examination and the total filtration  
is not known, subrule (2) of this rule may be assumed to have been met if the half-value  
layer is not less than any of the following:  
(a) 0.6 mm aluminum at 49 kVp.  
(b) 1.6 mm aluminum at 70 kVp.  
(c) 2.6 mm aluminum at 90 kVp.  
(4) Under conditions of subrule (3) of this rule, for tube potentials above 90 kVp,  
subrule (2) of this rule may be assumed to have been met if the half-value layer is not less  
than that specified in table 373-2.  
(5) The half-value layer of the useful beam for a given x-ray tube potential shall not  
be less than the values shown in table 373-2.  
TABLE 373-2  
Design Operating  
Range  
Measured  
Potential  
Half-value  
Layer  
(kVp)  
(kVp)  
(mm aluminum)  
Below 50  
30  
40  
49  
50  
60  
70  
80  
90  
0.3  
0.4  
0.5  
1.2  
1.3  
1.5  
2.3  
2.5  
2.7  
50 to 70  
Above 70  
100  
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110  
120  
130  
140  
150  
3.0  
3.2  
3.5  
3.8  
4.1  
(6) To determine the half-value layer at an x-ray tube potential which is not listed in  
table 373-2, linear interpolation or extrapolation may be made. Positive means shall be  
provided to ensure that at least the minimum filtration needed to achieve these beam  
quality requirements is in the useful beam during each exposure.  
(7) Radiographic equipment designed for use with an intraoral image receptor shall be  
provided with means to limit the x-ray beam to either of the following:  
(a) If the minimum source-skin distance is 18 centimeters or more, the x-ray field at  
the minimum source-skin shall be containable in a circle having a diameter of not more  
than 7 centimeters.  
(b) If the minimum source-skin is less than 18 centimeters, the x-ray field at the  
minimum SSD shall be containable in a circle having a diameter of not more than 6  
centimeters.  
(8) For intraoral exposures, means shall be provided to limit the source-skin distance  
to not less than 18 centimeters with apparatus operable above 50 kVp, and not less than  
10 centimeters with apparatus not operable above 50 kVp. Open-ended cones are  
recommended to reduce scattered radiation.  
(9) Mechanical support of the tube head and pointer cone shall maintain the exposure  
position without drift or vibration of sufficient magnitude to cause the need for manually  
restraining the tube or retaking the x-ray.  
(10) A device shall be provided that terminates the exposure at a preset time interval  
or exposure limit. The operator shall be able to terminate the exposure at any time by  
discontinuing pressure upon the exposure switch except that during serial radiography  
means may be provided to permit completion of a single exposure of the series in  
progress.  
(11) If a recycling timer is employed, it shall not be possible to make a repeat  
exposure without release of the exposure switch to reset the timer.  
(12) The exposure control switch shall have a circuit-closing contact which can be  
maintained only by continuous pressure on the switch by the operator.  
(13) Unless protective shielding is provided for the operator, the length of the  
exposure control switch cord or remote control location shall be such that the operator  
shall be able to stand at least 1.8 meters (6 feet) away from the patient and the x-ray tube  
and out of the useful beam.  
(14) The control panel shall provide positive visual identification of the production of  
x-rays when the x-ray tube is energized. A milliammeter may meet the requirements of  
this subrule.  
(15) A signal audible to the operator shall indicate that the exposure has ended.  
(16) The technique factors to be used during an exposure shall be indicated before the  
exposure begins, except when automatic exposure controls are used, in which case the  
technique factors which are set before the exposure shall be indicated. On equipment  
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having fixed technique factors, this requirement may be met by permanent markings.  
Indication of technique factors shall be visible from the operator's position.  
History: 2016 AACS.  
R 333.5375 Shielding.  
Rule 375. Conventional building materials in partitions, floors, and ceilings may  
provide adequate radiation shielding for dental installations. When a conventional  
building structure does not provide adequate shielding, the shielding shall be increased by  
providing greater thickness of building materials or by adding lead, concrete, steel, or  
other suitable materials to the walls, floor, and ceiling of an existing room. Shielding  
shall be subject to approval by the department.  
History: 2016 AACS.  
R 333.5376 Conditions of operation.  
Rule 376. (1) Deliberate exposure of an individual to the useful beam for training or  
demonstration purposes shall not be permitted unless there is a diagnostic need for the  
exposure and the exposure is prescribed by a dentist or physician.  
(2) The operator or the assistant shall not hold the image receptor in place for the  
patient during the exposure.  
(3) During the exposure, the operator shall stand at least 1.8 meters (6 feet) from the  
patient and the x-ray tube and outside the useful beam or behind a suitable barrier.  
(4) Only an individual whose presence is necessary to conduct the radiographic  
examination shall be permitted in the radiographic room during exposure.  
(5) The operator shall direct the x-ray tube such that the useful beam strikes a primary  
barrier or unoccupied area after emerging from the patient.  
(6) Neither the tube housing nor the cone shall be hand-held during the exposure.  
(7) Fluoroscopy shall not be used in dental examinations.  
(8) The exposure to the patient shall be kept to the practical minimum consistent with  
clinical objectives.  
(9) The x-ray beam and the image receptor shall be aligned very carefully with the  
area to be radiographed.  
(10) Processing materials and techniques shall be those recommended by the x-ray  
film manufacturer unless otherwise tested to ensure maximum information content of the  
developed film. Sight developing is not permitted except under extreme emergency  
conditions. Correct temperature control and development time are necessary to minimize  
radiation dose to the patient.  
(11) A radiographic x-ray system shall not be left unattended without locking the  
apparatus, room, or building in some manner which prevents use of the apparatus by  
unauthorized persons.  
History: 2016 AACS.  
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MULTIPLE TUBE INSTALLATIONS  
R 333.5378 Scope.  
Rule 378. R 333.5379 to R 333.5381 apply to installations consisting of more than 1  
x-ray source in the same room, or of sources located in separate rooms. These  
installations may include 2 or more complete x-ray units (single tube units), or a  
combination of 2 or more x-ray tube heads operable from a single control panel (multiple  
tube units).  
History: 2016 AACS.  
R 333.5379 X-ray equipment.  
Rule 379. (1) X-ray equipment in multiple tube installations shall meet the  
requirements of R 333.5373 with regard to each tube housing assembly and each  
complete x-ray unit.  
(2) On multiple tube units, there shall be indication at the control panel showing  
which tube is connected and ready to be energized and means to prevent energizing more  
than 1 tube head at the same time.  
(3) For multiple tube units there shall be indication at the tube housing assembly  
when it is connected and ready to be energized.  
History: 2016 AACS.  
R 333.5380 Shielding.  
Rule 380. Conventional building materials in partitions, floors, and ceilings may  
provide adequate radiation shielding for dental installations. When a conventional  
building structure does not provide adequate shielding, the shielding shall be increased by  
providing greater thickness of building materials or by adding lead, concrete, steel, or  
other suitable materials to the walls, floor, and ceiling of an existing room. In multiple  
tube installations the possibility of exposure from multiple sources shall be considered.  
Shielding shall be subject to approval by the department.  
History: 2016 AACS.  
R 333.5381 Conditions of operation.  
Rule 381. Operation shall meet the requirements of R 333.5376.  
History: 2016 AACS.  
PANORAMIC INSTALLATIONS  
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R 333.5383 Scope.  
Rule 383. R 333.5384 to R 333.5386 apply to panoramic installations and protective  
enclosures.  
History: 2016 AACS.  
R 333.5384 X-ray equipment.  
Rule 384. (1) X-ray equipment in panoramic installations shall meet the requirements  
of R 333.5373 excluding subrules (7) to (11).  
(2) For purposes of this rule, "image receptor" means that portion of the x-ray film or  
digital receptor instantaneously exposed by the x-ray beam subtended by a beam-limiting  
diaphragm immediately adjacent to the front of the radiographic film or digital receptor,  
if the panoramic technique requires this diaphragm.  
(3) The x-ray tube housing shall be provided with a beam-limiting diaphragm which  
shall limit the field at the plane of the image receptor to dimensions not exceeding the  
dimensions of the image receptor and shall align the center of the x-ray field with the  
center of the image receptor to within 2% of the SID.  
(4) Mechanical support of the tube head and image receptor shall maintain beam  
alignment without drift or vibration of sufficient magnitude to cause the need for  
manually restraining the tube or retaking the x-ray.  
(5) A device shall be provided which terminates the exposure at a preset time interval  
or exposure limit. The operator shall be able to terminate the exposure at any time by  
discontinuing pressure upon the exposure switch.  
History: 2016 AACS.  
R 333.5385 Shielding.  
Rule 385. Conventional building materials in partitions, floors, and ceilings may  
provide adequate radiation shielding for panoramic installations. When a conventional  
building structure does not provide adequate shielding, the shielding shall be increased by  
providing greater thickness of building materials or by adding lead, concrete, steel, or  
other suitable materials to the walls, floor, and ceiling of an existing room. Shielding  
shall be subject to approval by the department.  
History: 2016 AACS.  
R 333.5386 Conditions of operation.  
Rule 386. Operation shall meet the requirements of R 333.5376.  
History: 2016 AACS.  
CEPHALOMETRIC INSTALLATIONS  
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R 333.5388 Scope.  
Rule 388. R 333.5389 to R 333.5391 apply to installations consisting of an x-ray  
source used for the production of radiographs of the skull or related extra-oral  
radiographs, its individual control unit, and protective enclosure.  
History: 2016 AACS.  
R 333.5389 X-ray equipment.  
Rule 389. (1) X-ray equipment in cephalometric installations shall meet the  
requirements of R 333.5373 excluding subrules (7), (8), (9), and (13).  
(2) Beam-limiting devices such as diaphragms, cones, or adjustable collimators,  
capable of restricting the useful beam to the area radiographically recorded shall be  
provided to define the beam and shall provide the same degree of attenuation as that  
required of the tube housing.  
(3) Beam-limiting devices shall be calibrated in terms of the size of the projected  
useful beam at specified source-image receptor distances. This calibration shall be  
clearly and permanently recorded on the beam-limiting device. Calibration of adjustable  
beam-limiting devices shall permit reproducible settings.  
(4) X-ray systems designed for only 1 image receptor size at a fixed SID shall be  
provided with means to limit the field at the plane of the image receptor to dimensions  
not exceeding those of the image receptor, and to align the center of the x-ray field with  
the center of the image receptor to within 2% of the SID.  
(5) The size of the x-ray beam projected by fixed aperture beam-limiting devices,  
except those used for stereoradiography, shall not exceed the dimensions of the image  
receptor by more than 2% of the SID when the axis of the x-ray beam is perpendicular to  
the plane of the image receptor.  
(6) The calibrated field size indicator on adjustable beam-limiting devices shall be  
accurate to within 2% of the SID. The light field shall be aligned with the x-ray field  
with the same degree of accuracy. The field size projected by automatic adjustable  
beam-limiting devices shall provide the same precision.  
(7) For radiographic procedures resulting in multiple views on a single image receptor  
the beam-limiting device shall limit the x-ray field size to the recorded radiographic  
image within 2% of the SID. Covering a portion of the image receptor with radio-opaque  
material is not a substitute for proper x-ray field limitation.  
History: 2016 AACS.  
R 333.5390 Shielding.  
Rule 390. (1) The degree of protection required shall be determined by the workload,  
use and occupancy factors, and the tube potential, tube current, mechanical movement,  
and distance. The design shall be subject to approval by the department.  
(2) In a radiographic room, wall and floor areas exposed to the useful beam plus an  
area extending at least 30 centimeters (1 foot) beyond shall be provided with a primary  
protective barrier where necessary as determined by workload, use and occupancy  
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factors, and distance. All vertical primary protective barriers specified in this rule shall  
extend continuously from the floor to a minimum height of 2.1 meters (7 feet).  
(3) Secondary protective barriers shall be provided in the radiographic room ceiling  
and in those walls not requiring primary barriers.  
(4) Control apparatus for the radiographic equipment shall be shielded by a non-  
removable primary protective barrier extending to a minimum height of 2.1 meters (7  
feet).  
(5) Exposure switch location and control shield shall be oriented such that, at arm's  
length from the exposure switch, the operator shall not be exposed to the useful beam,  
leakage radiation, or radiation that has been scattered only once.  
(6) The operator shall be able to see and communicate with the patient from a  
shielded position at the control panel. When an observation window is provided, it shall  
have a lead equivalence at least equal to that required of the control barrier and shall be  
installed such that the attenuation effectiveness of the barrier is not impaired.  
History: 2016 AACS.  
R 333.5391 Conditions of operation.  
Rule 391. Operation shall meet the requirements of R 333.5376 excluding subrule (3).  
History: 2016 AACS.  
MULTIPLE PURPOSE INSTALLATIONS  
R 333.5395 General provisions.  
Rule 395. (1) This rule applies to installations consisting of an x-ray source or sources  
used for 2 or more purposes described in R 333.5372 to R 333.5391.  
(2) X-ray equipment in multiple purpose installations shall meet the applicable  
requirements of R 333.5373, R 333.5379, R 333.5384, and R 333.5389 for each mode of  
operation permitted by the design of the equipment.  
(3) Shielding in multiple purpose installations shall meet the applicable requirements  
of R 333.5375, R 333.5380, R 333.5385, and R 333.5390 for each mode of operation  
permitted by the design of the equipment.  
(4) Operation in multiple purpose installations shall meet the applicable requirements  
of R 333.5376, R 333.5381, R 333.5386, and R 333.5391 for each mode of operation  
permitted by the design of the equipment.  
History: 2016 AACS.  
HAND-HELD PORTABLE DENTAL X-RAY SYSTEMS  
R 333.5396 Hand-held portable dental x-ray systems.  
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Rule 396. (1) As used in this section, “handheld dental X-ray system” or “system”  
means an X-ray system that is used to take radiographs, is designed to be handheld during  
its operation, and is portable.  
(2) A handheld dental X-ray system that meets the requirements described in this  
section may be used for routine dental radiography in a dental office or a situation in  
which it is impractical to transfer a patient to a radiation machine that is stationary.  
(3) X-ray equipment designed to be hand-held must meet the requirements of R  
333.5373, excluding subrules (9) and (13).  
(4)The x-ray tube housing for tubes designed to be hand-held must be constructed so  
that the leakage radiation measured in air at a distance 5 centimeters from a point on the  
external surface does not exceed 0.02 mGy (2 milliroentgens) in 1 hour when operated  
under conditions of maximum radiation output permitted by the design or operating  
characteristics of the radiation machine.  
(5) Operation of a hand-held portable x-ray system must meet the requirements of R  
333.5376, excluding subrules (3) and (6).  
(6) A person shall not use a handheld dental X-ray system to perform dental  
radiography unless the machine is registered with the department under department rules  
for registration of radiation machines and the system, the personnel operating the system,  
and the facility in which the system is used meet all of the following requirements:  
(a) The system has been approved for human use by the United States Food and  
Drug Administration and is used in a manner consistent with that approval.  
(b) The system has a backscatter shield that meets all of the following requirements:  
(i) The shield is composed of a leaded polymer or a lead-equivalent substance that  
has a substantially equivalent protective capacity.  
(ii) The shield has at least 0.5 millimeters of lead or lead-equivalent shielding, as  
determined by the department.  
(iii) The shield is permanently affixed to the system.  
(c) The system is calibrated by its manufacturer before its first use and is  
recalibrated at least every 24 months after the date of the last calibration.  
(d) When not in use, the system is stored in a manner that restricts access to the  
system, such as by storing the system in a locked area of the facility.  
(e) Each individual who operates the system is an individual who is authorized to  
operate a dental radiography machine pursuant to rules promulgated under part 166 of the  
act, MCL 333.16601 to 333.16659.  
(f) An individual operating the system is not required to wear a lead apron or other  
personal monitoring equipment while operating the system if it is determined that the use  
of the system is in compliance with part 381 of the Michigan occupational safety and  
health administration general industry safety and health standards, R 325.60601a to R  
325.60618, or equivalent federal occupational safety and health standards; part 33 of the  
Michigan occupational safety and health administration general industry safety and health  
standard, R 408.13301 to R 408.13395g, or equivalent federal occupational safety and  
health standards; R 333.5057; and R 333.5063 to R 333.5065. However, upon request, a  
registrant shall make a lead apron or other personal monitoring equipment available to an  
individual who operates the system.  
(g) The system is not used if the backscatter shield described in subdivision (b) of  
this subrule is broken, missing, or malfunctioning.  
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(7) An operator shall complete the training program supplied by the manufacturer  
and approved by the department before using the x-ray unit. Records of the training shall  
be maintained on file for examination by the department.  
History: 2016 AACS; 2020 MR 18, Eff Oct 5, 2020.  
OTHER TYPES OF INSTALLATIONS  
R 333.5397 General provisions.  
Rule 397. (1) This rule applies to dental x-ray producing equipment and devices not  
specifically covered elsewhere by this part.  
(2) Types of dental x-ray sources and uses not specifically covered by this part and  
not exempted under R 333.5033 shall meet the requirements of R 333.5001 to  
R 333.5101.  
History: 2016 AACS.  
PART 10. VETERINARY X-RAY INSTALLATIONS  
R 333.5401 Purpose and scope.  
Rule 401. (1) This part establishes requirements governing the use of x-radiation in  
veterinary medicine.  
(2) This part applies to all registrants who use x-radiation in veterinary medicine or  
research for the intentional exposure of animals.  
(3) In addition to the requirements of this part, all registrants are subject to  
R 333.5001 to R 333.5101 and all applicable provisions of the other parts.  
History: 2016 AACS.  
THERAPEUTIC MACHINES USED FOR VETERINARY X-RAY  
TREATMENT  
R 333.5402 X-ray equipment.  
Rule 402. The x-ray equipment shall meet the requirements of R 333.5312 and  
R 333.5321.  
History: 2016 AACS.  
R 333.5403 Enclosures.  
Rule 403. The enclosure shall meet the requirements of R 333.5315 and R 333.5322.  
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History: 2016 AACS.  
R 333.5404 Conditions of operation.  
Rule 404. (1) Operation shall meet the requirements of R 333.5317 excluding  
subrules (2), (5), (6), and (11).  
(2) The output of the x-ray generator should be calibrated initially before use for the  
treatment of animals. It should also be recalibrated after each tube replacement and after  
all changes or replacement in the generating apparatus which could affect a change in the  
x-ray output. Check calibrations should be made on an annual basis and records of all  
calibration maintained for not less than 5 years.  
(3) Patients shall not be hand-held in position for radiation therapy. Mechanical  
supporting or restraining devices shall be used if restraint is required.  
(4) An individual shall not be permitted in the treatment room when the tube is  
operated at any potential.  
(5) The x-ray tube of a contact therapy machine as defined in R 333.5321(3) shall not  
be hand-held during irradiation. When practical, a cap of at least 0.5 millimeter lead  
equivalence should cover the aperture window of the tube housing of the apparatus when  
the apparatus is not being used. Because the exposure rate at the surface of the window  
of contact therapy and beryllium window machines may be more than 10,000 roentgens  
per minute, extreme precautions are necessary to prevent accidental exposure to the  
useful beam.  
(6) Lead, lead rubber, lead foil, and similar materials used for limiting the field,  
should not transmit more than 5% of the useful beam under the conditions at which the  
machine is operated for therapy.  
History: 2016 AACS.  
FIXED RADIOGRAPHIC INSTALLATIONS  
R 333.5405 X-ray equipment.  
Rule 405. (1) All x-ray tube housings in fixed radiographic installations shall be of  
the diagnostic type.  
(2) The aluminum equivalent of the total filtration in the useful beam shall not be less  
than the values shown in table 405.  
TABLE 405  
Operating Potential  
Minimum Total Filter  
(Inherent plus added)  
0.5 mm aluminum  
1.5 mm aluminum  
2.5 mm aluminum  
Below 50 kVp  
50 - 70 kVp  
Above 70 kVp  
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(3) Beam-limiting devices, such as diaphragms, cones, or adjustable collimators,  
capable of restricting the useful beam to the area radiographically recorded shall be  
provided to define the beam and shall provide the same degree of attenuation as that  
required of the tube housing.  
(4) Beam-limiting devices shall be calibrated in terms of the size of the projected  
useful beam at specified source-image receptor distances (SID). This calibration shall be  
clearly and permanently recorded on the beam-limiting device. Calibration of adjustable  
beam-limiting devices shall permit reproducible settings.  
(5) X-ray systems designed for only 1 image receptor size at a fixed SID shall be  
provided with means to limit the field at the plane of the image receptor to dimensions  
not greater than those of the image receptor, and to align the center of the x-ray field with  
the center of the image receptor to within 2% of the SID.  
(6) General purpose radiographic x-ray systems should be equipped with adjustable  
beam-limiting devices containing light localizers that define the entire field.  
(7) The size of the x-ray beam projected by fixed aperture beam-limiting devices,  
except those used for stereoradiography, shall not exceed the dimensions of the image  
receptor by more than 2% of the SID when the axis of the x-ray beam is perpendicular to  
the plane of the image receptor.  
(8) The calibrated field size indicator on adjustable beam-limiting devices shall be  
accurate to within 2% of the SID. The light field shall be aligned with the x-ray field  
with the same degree of accuracy. The field size projected by automatic adjustable  
beam-limiting devices shall provide the same precision.  
(9) For radiographic procedures resulting in multiple views on a single image receptor  
the beam-limiting device shall limit the x-ray field size to the recorded radiographic  
image size within 2% of the SID. Covering a portion of the image receptor with radio-  
opaque material is not a substitute for proper x-ray field limitation.  
(10) A device shall be provided which terminates the exposure at a preset time  
interval or exposure limit. The operator shall be able to terminate the exposure at all  
times by discontinuing pressure upon the exposure switch except that during serial  
radiography means may be provided to permit completion of a single exposure of the  
series in progress.  
(11) A primary radiographic exposure switch shall be provided which shall be  
securely fixed so that the operator shall be behind a fixed shield which intercepts the  
useful beam and radiation which has been scattered only once.  
(12) An auxiliary foot switch may be provided to activate the radiographic tube in  
addition to, but not in substitution of, the requirement of subrule (11) of this rule. This  
auxiliary switch need not be fastened behind a fixed shield.  
(13) The control panel shall provide positive visual identification of the production of  
x-rays when the x-ray tube is energized. A milliammeter may meet the requirement of  
this subrule.  
(14) A signal audible to the operator shall indicate that the exposure has ended.  
(15) The technique factors to be used during an exposure shall be indicated before the  
exposure begins. When automatic exposure controls are used, only those technique  
factors which are set before the exposure shall be indicated. On equipment having fixed  
technique factors, this requirement may be met by permanent markings. Indication of  
technique factors shall be visible from the operator's position.  
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History: 2016 AACS.  
R 333.5407 Enclosures.  
Rule 407 (1) An enclosure shall be a permanent part of the building or equipment.  
Portable shields shall not be used for permanent installations.  
(2) The degree of protection required for an enclosure shall be determined by the  
workload, use and occupancy factors, and the tube potential, tube current, mechanical  
movement, and distance. The design shall be subject to approval by the department.  
(3) In a radiographic room, wall and floor areas exposed to the useful beam plus an  
additional area extending at least 30 centimeters (1 foot) beyond shall be provided with a  
primary protective barrier as determined by workload, use and occupancy factors, and  
distance. All vertical primary protective barriers specified in this rule shall extend  
continuously from the floor to a minimum height of 2.1 meters (7 feet).  
(4) Secondary protective barriers shall be provided in the radiographic room ceiling  
and in those walls not requiring primary barriers.  
(5) Control apparatus for the radiographic equipment shall be shielded by a primary  
protective barrier which cannot be removed from a protective position between the  
operator and the radiation source during machine operation.  
(6) Movable barriers with electrical interlocks shall not be approved in place of  
compliance with subrule (5) of this rule.  
(7) The primary exposure switch location and control shield shall be oriented so that,  
at arm's length from the exposure switch, the operator shall not be exposed to the useful  
beam, leakage radiation, or radiation which has been scattered only once.  
(8) The operator shall be able to see and communicate with personnel within the room  
from a shielded position at the control panel. When an observation window is provided,  
it shall have a lead equivalence at least equal to that required of the control barrier and  
shall be installed so that the attenuation effectiveness of the barrier is not impaired.  
(9) At times it may be necessary for personnel to remain within operating room or  
special procedure installations during radiographic exposures. A primary protective  
barrier shall be provided for personnel protection under these circumstances unless  
necessary technique prevents its use. This barrier may be movable if necessary.  
Movable barriers shall not be permitted in place of the provisions of subrules (3) and (5)  
of this rule.  
History: 2016 AACS.  
R 333.5409 Conditions of operation.  
Rule 409. (1) An operator shall properly utilize the beam-limiting devices provided to  
restrict the useful beam to the smallest area consistent with clinical requirements.  
Particular care shall be taken to align accurately the x-ray beam with the patient and film.  
(2) The operator shall ensure the presence of adequate filtration before a radiographic  
procedure pursuant to R 333.5405(2).  
(3) When a patient or film is held in position for radiography, mechanical supporting  
or restraining devices shall be available and shall be used unless contraindicated. Proper  
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use of these devices shall permit the operator to stand behind the primary control shield  
during most radiographic procedures.  
(4) If the patient or film is held by 1 or more individuals, each individual shall wear  
protective gloves and body aprons of 0.5 millimeter minimum lead equivalence. Each  
individual shall be so positioned that no part of his or her body is struck by the useful  
beam and that his or her body is as far as possible from the edge of the useful beam.  
(5) Only individuals whose presence is necessary shall be permitted in the  
radiographic room during an exposure. These individuals shall be protected as specified  
in subrule (4) of this rule unless protected by an approved primary barrier.  
(6) If an auxiliary foot switch is provided as specified in R 333.5405(12), it shall be  
used only by a licensed veterinarian and only at times when sufficient personnel are not  
available to permit use of the primary exposure switch specified in R 333.5405(11).  
(7) To protect the feet of the veterinarian or his or her assistant from the primary  
beam while restraining patients, the underside of the radiographic table shall be protected  
by at least 1.6 millimeter (1/16 inch) lead or equivalent protection approved by the  
department.  
(8) Personnel monitoring shall be performed in controlled areas for each individual  
occupationally exposed to ionizing radiation from diagnostic x-ray equipment.  
Individual monitoring devices, such as film badge dosimeters or thermoluminescent  
dosimeters, shall be permanently assigned to each occupationally exposed individual.  
This monitoring shall be continuous during employment as a radiation worker.  
(9) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs.  
(10) Monitoring devices used to estimate whole body exposure shall normally be  
worn on the chest or abdomen. Monitoring of all other body parts shall comply with  
R 333.5065.  
(11) Monitoring devices worn to estimate personnel occupational exposure shall not  
be worn by the individual when he or she is exposed as a patient for a medical or dental  
reason.  
(12) Medical x-ray screen type films and intensifying screens shall be employed to  
reduce patient exposure except in cases where a noticeable decrease in image definition  
resulting from increased sensitivity may reduce the clinical value of the examination.  
(13) Film processing materials and techniques shall be those recommended by the x-  
ray film and processing materials manufacturers unless otherwise tested to ensure  
maximum information content of the developed film. Sight developing is not permitted  
except under extreme emergency conditions.  
Correct temperature control and  
development time are necessary to minimize radiation dose to the patient.  
(14) A radiographic x-ray system shall not be left unattended without locking the  
apparatus, room, or building in some manner which prevents use of the apparatus by  
unauthorized persons.  
History: 2016 AACS.  
FIXED FLUOROSCOPIC INSTALLATIONS  
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R 333.5411 X-ray equipment.  
Rule 411. (1) All x-ray tube housings in fixed fluoroscopic installations shall be of  
the diagnostic type.  
(2) The aluminum equivalent of the total filtration permanently in the useful beam  
shall not be less than 2.5 millimeters aluminum.  
(3) The source-patient distance on fluoroscopic machines should not be less than 45  
centimeters (18 inches) and shall not be less than 30 centimeters (12 inches).  
(4) Provision shall be made to intercept the scattered x-rays from the undersurface of  
the table top and other structures under the fluoroscopic table if the tube is mounted  
under the table. A cone or shield shall provide the same degree of attenuation as is  
required of the tube housing.  
(5) A shielding device of at least 0.25 millimeter lead equivalence for covering the  
bucky slot during fluoroscopy shall be provided.  
(6) A shielding device of at least 0.25 millimeter lead equivalence, such as  
overlapping protective drapes or hinged or sliding panels, shall be used to intercept  
scattered radiation that would otherwise reach the fluoroscopist and others near the  
machine.  
(7) A fluoroscopic machine shall comply with both of the following:  
(a) The entire cross section of the useful beam shall be intercepted by the primary  
protective barrier of the fluoroscopic image assembly at any SID. The fluoroscopic tube  
shall not produce x-rays unless the barrier is in position to intercept the entire useful  
beam. The exposure rate due to transmission through the barrier with the attenuation  
block in the useful beam combined with radiation from the image intensifier, if provided,  
shall not exceed 2 milliroentgens per hour at 10 centimeters from an accessible surface of  
the fluoroscopic imaging assembly beyond the plane of the image receptor for each  
roentgen per minute of entrance exposure rate.  
(b) The entrance exposure rate shall be measured as described in subrule (15) of this  
rule. The exposure rate due to transmission through the primary barrier combined with  
radiation from the image intensifier shall be determined by measurements averaged over  
an area of 100 square centimeters with no linear dimension greater than 20 centimeters.  
If the source is below the tabletop, the measurement shall be made with the input surface  
of the fluoroscopic imaging assembly positioned 30 centimeters above the tabletop. If  
the source is above the tabletop and the SID is variable, the measurement shall be made  
with the end of the beam-limiting device or spacer as close to the tabletop as it can be  
placed, if it is not closer than 30 centimeters. Movable grids and compression devices  
shall be removed from the useful beam during the measurement. For all measurements,  
the attenuation block shall be positioned in the useful beam 10 centimeters from the point  
of measurement of the entrance exposure rate and between this point and the input  
surface of the fluoroscopic imaging assembly.  
(8) The lead equivalence of the barrier of conventional fluoroscopes shall be not less  
than 1.5 millimeters at 100 kVp, 1.8 millimeters at 125 kVp, and 2.0 millimeters at  
potentials greater than 125 kVp.  
(9) A beam-limiting device shall be provided to restrict the size of the useful beam to  
less than the area of the barrier. The x-ray tube and beam-limiting system shall be linked  
with the fluorescent screen assembly so that the useful beam at the fluorescent screen is  
confined within the barrier irrespective of the panel-screen distance. For image  
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intensifiers, the useful beam shall be centered on the input phosphor. It should not  
exceed the diameter of the input phosphor during fluoroscopy or cine-recording. For spot  
film radiography with image intensifier equipment, the shutters should automatically  
open to the required field size before the exposure.  
(10) Beam-limiting devices, such as collimators, adjustable diaphragms, or shutters,  
shall provide the same degree of attenuation as is required of the tube housing.  
(11) A fluoroscopic machine shall comply with either of the following:  
(a) The x-ray field produced by nonimage-intensified fluoroscopic equipment shall  
not extend beyond the entire visible area of the image receptor. Means shall be provided  
to permit further limitation of the field. The minimum field size at the greatest SID shall  
be equal to or less than 5 by 5 centimeters.  
(b) For image-intensified fluoroscopic equipment, the total misalignment of the edges  
of the x-ray field with the respective edges of the visible area of the image receptor along  
any dimension of the visually defined field in the plane of the image receptor shall not  
exceed 3% of the SID. The sum, without regard to sign, of the misalignment along any 2  
orthogonal dimensions intersecting at the center of the visible area of the image receptor  
shall not exceed 4% of the SID. For rectangular x-ray fields used with circular image  
receptors, the error in alignment shall be determined along the length and width  
dimensions of the x-ray field which pass through the center of the visible area of the  
image receptor. Means shall be provided to permit further limitation of the field. The  
minimum field size, at the greatest SID, shall be equal to or less than 5 by 5 centimeters.  
(12) X-ray production in the fluoroscopic mode shall be controlled by a device that  
requires continuous pressure by the operator for the entire time of an exposure. When  
recording serial fluoroscopic images, the operator shall be able to terminate the x-ray  
exposures at any time, but means may be provided to permit completion of any single  
exposure of the series in progress.  
(13) When the fluoroscope is operated at 80 kVp, the exposure rate at the position  
where the beam enters the patient shall not exceed 3.2 R/mA-min and should not exceed  
2.1 R/mA-min.  
(14) Entrance exposure rate limits for fluoroscopic machines shall be as follows:  
(a) Machines with automatic exposure rate control shall not be operable at a  
combination of tube potential and current which results in an exposure rate in excess of  
10 roentgens per minute at the point where the center of the useful beam enters the  
patient, except during recording of fluoroscopic images or when an optional high level  
control is provided. Special means of activation of high level controls, such as additional  
pressure applied continuously by the operator, shall be required to avoid accidental use.  
A continuous signal audible to the fluoroscopist shall indicate that the high level control  
is being employed.  
(b) Machines without automatic exposure rate control shall not be operable at a  
combination of tube potential and current which results in an exposure rate in excess of 5  
roentgens per minute at the point where the center of the useful beam enters the patient,  
except during recording of fluoroscopic images or when an optional high level control is  
activated. Special means of activation of high level controls, such as additional pressure  
applied continuously by the operator, shall be provided to avoid accidental use. A  
continuous signal audible to the fluoroscopist shall indicate that the high level control is  
being employed.  
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(15) Compliance with subrule (14) of this rule shall be determined as follows:  
(a) If the source is below the table, the exposure rate shall be measured 1 centimeter  
above the tabletop or cradle.  
(b) If the source is above the table, the exposure rate shall be measured at 30  
centimeters above the tabletop with the end of the beam-limiting device or spacer  
positioned as closely as possible to the point of measurement.  
(c) In a C-arm type of fluoroscope, the exposure rate shall be measured 30  
centimeters from the input surface of the fluoroscopic imaging assembly.  
(16) Means shall be provided to preset the cumulative on-time of the fluoroscopic  
tube. The maximum cumulative time of the timing device shall not exceed 5 minutes  
without resetting. A signal audible to the fluoroscopist shall indicate the completion of  
the preset cumulative on-time. This signal shall continue to sound while x-rays are  
produced until the timing device is reset.  
(17) Devices which indicate the x-ray tube potential and current shall be provided.  
On image intensified fluoroscopic equipment, these devices should be located in such a  
manner that the operator may monitor the tube potential and current during fluoroscopy.  
History: 2016 AACS.  
Editor's Note: An obvious error in R 325.5411 was corrected at the request of the promulgating  
agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL 24.256. The rule  
containing the error was published in Michigan Register, 2016 MR 10. The memorandum requesting the  
correction was published in Michigan Register, 2016 MR 16.  
R 333.5417 Enclosures.  
Rule 417. (1) An enclosure shall be a permanent part of the building or equipment.  
Portable shields shall not be used for permanent installations.  
(2) The degree of protection required for an enclosure shall be determined by the  
workload, the use and occupancy factors, and the tube potential, tube current, mechanical  
movement, and distance. The design shall be subject to approval by the department.  
(3) For conventional fluoroscopy extraneous light that interferes with the fluoroscopic  
examination shall be eliminated. Dark adaptation normally is not necessary when using  
image intensifiers.  
History: 2016 AACS.  
R 333.5418 Conditions of operation.  
Rule 418. (1) An individual present in a fluoroscopic room shall wear a protective  
apron of at least 0.5 millimeter lead equivalence.  
(2) Only individuals whose presence is needed to conduct the examination, to conduct  
radiation protection surveys, or to undergo specific training shall be permitted in the  
fluoroscopy room during x-ray exposures.  
(3) Personnel monitoring shall be performed in controlled areas for each individual  
occupationally exposed to ionizing radiation from diagnostic x-ray equipment.  
Individual monitoring devices, such as film badge dosimeters or thermoluminescent  
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dosimeters, shall be permanently assigned to each occupationally exposed individual.  
This monitoring shall be continuous during employment as a radiation worker.  
(4) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs.  
(5) Monitoring devices used to estimate whole body exposure shall normally be worn  
on the chest or abdomen. Monitoring of all other body parts shall meet the requirements  
of R 333.5065.  
(6) Monitoring devices worn to estimate personnel occupational exposure shall not be  
worn by the individual when he or she is exposed as a patient for a medical or dental  
reason.  
(7) The fluoroscopist's eyes should be sufficiently dark-adapted for the visual task  
required before commencing conventional fluoroscopy. Under no circumstances shall he  
or she attempt to compensate for inadequate adaptation by increasing exposure factors  
employed or by prolonging the fluoroscopic examination.  
(8) A fluoroscopic x-ray system shall not be left unattended without locking the  
apparatus, room, or building in some manner which prevents use of the apparatus by  
unauthorized persons.  
History: 2016 AACS.  
MOBILE OR PORTABLE DIAGNOSTIC X-RAY EQUIPMENT  
R 333.5421 X-ray equipment.  
Rule 421. (1) Radiographic x-ray equipment shall meet the requirements of  
R 333.5405 excluding subrules (5) and (11).  
(2) Fluoroscopic x-ray equipment shall meet the requirements of R 333.5411  
excluding subrules (3), (4), (5), and (7).  
(3) The radiographic exposure control switch shall be located on the machine where  
adequate personnel protection is provided to attenuate the direct and scatter radiation, or  
the length of switch cord shall be such that the operator shall be able to stand at least 1.8  
meters (6 feet) from the patient, the x-ray tube, and out of the useful beam. A coil type  
extension switch cord capable of providing more than 1.8 meters (6 feet) of distance  
protection is recommended.  
(4) Hand-held fluoroscopic screens and others not attached to a diagnostic source  
assembly with stable mounting shall not be used.  
(5) Image intensification shall always be provided on mobile fluoroscopic equipment.  
Mobile fluoroscopic equipment shall be impossible to operate unless the useful beam is  
intercepted by the image intensifier. Means shall be provided to limit the source-skin  
distance to not less than 30 centimeters (12 inches). For fluoroscopes intended for  
specific surgical application that would be prohibited at the source-skin distances  
specified in this subrule, provisions may be made for operation at shorter source-skin  
distances but in no case less than 20 centimeters.  
History: 2016 AACS.  
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R 333.5422 Shielding.  
Rule 422. (1) Portable shielding of at least 1.6 millimeter (1/16 inch) lead equivalent  
shall be used by the operator and other individuals nearby when possible.  
(2) Mobile or portable diagnostic x-ray equipment used routinely in 1 location shall  
be considered a fixed installation and shall meet the requirements of R 333.5405 and  
R 333.5407, or R 333.5411 and R 333.5417, or both.  
History: 2016 AACS.  
R 333.5423 Conditions of operation.  
Rule 423. (1) Operation shall meet the requirements of R 333.5409 and R 333.5418.  
(2) Individuals operating mobile or portable diagnostic x-ray equipment shall wear a  
protective apron of minimum 0.5 millimeter lead equivalence unless portable shielding is  
provided as specified in of R 333.5422(1).  
History: 2016 AACS.  
MISCELLANEOUS AND SPECIAL INSTALLATIONS  
R 333.5425 General provisions.  
Rule 425. (1) Types of x-ray sources and uses not specifically covered by this part  
and not exempted in R 333.5033, shall meet the requirements in R 333.5001 to  
R 333.5101.  
(2) For the purpose of registering and approving veterinary x-ray producing  
equipment and devices not specifically covered by this part the protective design, the  
workload, the use factor, and the occupancy factor shall be considered.  
History: 2016 AACS.  
PART 11. PARTICLE ACCELERATOR INSTALLATIONS  
R 333.5431 Purpose and scope.  
Rule 431. (1) This part establishes procedures for the registration of particle  
accelerators, a classification system for particle accelerator installations and use, and  
radiation safety requirements for persons utilizing all types of particle accelerators except  
those specifically exempted from this part.  
(2) This part applies to all registrants who use particle accelerators for a purpose other  
than those exempted under R 333.5432.  
(3) In addition to the requirements of this part, all registrants are subject to the  
applicable provisions of these rules.  
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History: 2016 AACS.  
R 333.5432 Definition.  
Rule 432. "Particle accelerator" or "accelerator", as used in this part, means a  
radiation machine designed for or capable of accelerating electrically charged particles,  
such as electrons, protons or deuterons, with an electrical potential in excess of 1 MeV.  
Radiation machines designed and used exclusively for the production of electron beams  
or x-radiation for any of the following purposes except those capable of producing  
radioactive material in excess of exempt quantities listed in schedule B of R 325.5147 are  
excluded from this definition:  
(a) The diagnosis or treatment of patients.  
(b) Industrial radiography.  
(c) Examination of the microscopic structure of materials.  
(d) Manufacturing process control.  
(e) Research and development.  
(f) Demonstration of scientific principles for educational purposes.  
History: 2016 AACS.  
LICENSE OR REGISTRATION  
R 333.5435 General provisions.  
Rule 435. A person having a particle accelerator subject to this part shall comply with  
the registration requirements of R 333.5031 to R 333.5049.  
History: 2016 AACS.  
CLASSIFICATION  
R 333.5437 Class enumeration.  
Rule 437. (1) For registration and approval purposes, particle accelerator installations  
shall be classified as class AA, class A, class B, or class C.  
(2) For the purpose of registering and approving mobile or portable particle  
accelerators intended for limited use at temporary job site locations, this use shall be  
classified as class D operation.  
History: 2016 AACS.  
R 333.5438 Class AA installations.  
Rule 438. (1) In class AA installations the accelerator and objects exposed thereto  
shall be contained within a permanent enclosure.  
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(2) The enclosure shall be constructed so that the dose equivalent rate as measured in  
air at a distance of 5 centimeters from an accessible point on the external surface shall not  
exceed 2 millirems per hour under conditions of maximum radiation output permitted by  
the design or operating characteristics of the accelerator.  
(3) Mechanical or electrical limiters shall limit movement or alignment of the  
accelerated beam within the enclosure if necessary to comply with subrule (2) of this  
rule.  
(4) A personnel barrier posted pursuant to R 333.5067 to R 333.5072 restricting  
access to the roof of the enclosure shall meet the requirement of subrule (2) of this rule.  
(5) Reliable interlocks shall be provided which prevent an individual from opening  
the enclosure while the accelerator is in operation or which terminate machine operation  
if an individual opens the enclosure. These interlocks shall meet the requirements of  
R 333.5448.  
(6) Enclosures of sufficient size to permit human occupancy shall be provided with  
visible or audible signals or both within the enclosure which are activated a minimum of  
5 seconds before accelerator operation. Individuals shall at all times be able to escape  
from within the enclosure.  
(7) An individual shall not be permitted to remain within the enclosure while the  
accelerator is in operation except as a human patient undergoing radiation treatment.  
(8) Protective enclosures and equipment shall be kept in good repair.  
(9) Electron beam welders shall meet class AA requirements.  
(10) Class AA approval permits unlimited use at maximum capacity.  
History: 2016 AACS.  
R 333.5439 Class A installations.  
Rule 439. (1) Class A installations shall comply with all requirements of R 333.5438  
except for a permissible dose equivalent rate of 7 millirems per hour at an accessible  
external point.  
(2) An individual monitoring device, such as a film badge dosimeter or  
thermoluminescent dosimeter, shall be permanently assigned to each occupationally  
exposed individual. This monitoring shall be continuous during employment as a  
radiation worker.  
(3) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs.  
(4) Class A approval permits unlimited use at maximum capacity.  
History: 2016 AACS.  
R 333.5440 Class B installations.  
Rule 440. (1) Class B installations shall comply with all requirements of R 333.5439.  
(2) Accelerator beam current and potential controls shall be mechanically or  
electrically limited so as not to exceed the normal operating conditions as specified in the  
application for specific license or registration.  
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(3) Class B approval permits unlimited use under normal operating conditions as  
specified by subrule (2) of this rule.  
History: 2016 AACS.  
R 333.5441 Class C installations.  
Rule 441. (1) Class C installations shall comply with all requirements of R 333.5439  
except for a permissible dose equivalent rate of 50 millirems per hour at an accessible  
external point.  
(2) The maximum weekly accelerator beam on time shall be established by the  
department under the conditions specified in the application for specific license or  
registration.  
(3) Warning signs shall be posted in those areas outside the enclosure in which the  
radiation exposure dose equivalent rate in air at an accessible external point exceeds 2  
millirems per hour under conditions of maximum radiation output permitted by the  
design or limited operating characteristics of the accelerator.  
(4) A daily usage log shall be maintained to record machine operation. The record  
shall be available at the accelerator site for examination by the department.  
History: 2016 AACS.  
R 333.5442 Class D operations.  
Rule 442. (1) Particle accelerator operations conducted under conditions not meeting  
the provisions and requirements of R 333.5438 to R 333.5441 shall be classified as class  
D operations and shall not be operated longer than 30 days unless written authorization is  
granted by the department.  
(2) Written authorization in the form of a registration condition may be granted by the  
department for class D operations longer than 30 days but not longer than 6 months at 1  
location when an undue and unnecessary hardship may result from the 30-day limitation.  
Written request by the applicant for this authorization is required and shall describe the  
hardship involved as well as provide written assurance of compliance with the  
requirements of these rules for class D operation. This assurance shall be in the form of  
satisfactory written procedures which shall be approved by the department before the  
issuance of a certificate of registration.  
History: 2016 AACS.  
SAFETY REQUIREMENTS FOR THE USE OF PARTICLE  
ACCELERATORS  
R 333.5445 General provisions.  
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Rule 445. (1) R 333.5445 to R 333.5452 establish radiation safety requirements for  
the use of particle accelerators. These requirements are in addition to, and not in  
substitution for, other applicable provisions of these rules.  
(2) A registrant shall be responsible for assuring that all requirements of this part are  
met.  
History: 2016 AACS.  
R 333.5446 Limitations.  
Rule 446. (1) A registrant shall not permit an individual to act as an accelerator  
operator until the individual has met all of the following:  
(a) Been instructed and demonstrated an understanding of radiation safety.  
(b) Received copies of, instruction in, and demonstrated an understanding of  
R 333.5431 to R 333.5452 and the applicable requirements of all of the following:  
(i) R 333.5051 to R 333.5089.  
(ii) Pertinent registration conditions.  
(iii) The registrant's operating and emergency procedures.  
(c) Demonstrated competence to use the particle accelerator, related equipment, and  
survey instruments employed in his or her assignment.  
(2) The radiation safety committee or the radiation protection supervisor shall have  
the authority to terminate the operations at an accelerator facility or of a class D operation  
if this action is necessary to protect and minimize danger to public health and safety or  
property.  
History: 2016 AACS.  
R 333.5447 Shielding.  
Rule 447. (1) The design and shielding specifications for an accelerator shall be  
submitted to and approved by the department before issuance of a certificate of  
registration. After construction, the radiation safety of the installation shall be  
established by a protection survey conducted pursuant to R 333.5063. A written report of  
the initial survey shall be submitted to the department and approved in writing before  
continued operation of the accelerator.  
(2) An accelerator installation shall be provided with primary or secondary barriers as  
are necessary to ensure compliance with R 333.5057 to R 333.5061.  
History: 2016 AACS.  
R 333.5448 Accelerator controls and interlock systems.  
Rule 448. (1) Instrumentation, readouts, and controls on the accelerator control  
console shall be clearly identified and easily discernible.  
(2) All entrances or openings into a target room or other high radiation area shall be  
provided with interlocks.  
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(3) When an interlock system has been tripped, operation of the accelerator shall only  
be resumed by first manually resetting controls at the position where the interlock has  
been tripped, and lastly at the main control console.  
(4) A safety interlock shall be on a circuit which will allow it to operate  
independently of all other safety interlocks.  
(5) A safety interlock shall be fail safe. A defect or component failure in the interlock  
system shall prevent operation of the accelerator.  
(6) A scram button or other emergency power cutoff switch shall be located and  
easily identifiable in all high radiation areas. This cutoff switch shall include a manual  
reset so that the accelerator cannot be restarted from the accelerator control console  
without resetting the cutoff switch.  
History: 2016 AACS.  
R 333.5449 Warning devices.  
Rule 449. (1) Locations designated as high radiation areas, and entrances to these  
locations, shall be equipped with easily observable warning lights that operate when, and  
only when, radiation is being produced.  
(2) Except in installations designed for human exposure, a high radiation area shall  
have an audible warning device which shall be activated for 15 seconds before the  
possible creation of a high radiation area. This warning device shall be clearly  
discernible in all high radiation areas and all radiation areas.  
(3) Barriers and pathways leading to high radiation areas shall be identified pursuant  
to R 333.5067 to R 333.5074.  
History: 2016 AACS.  
R 333.5450 Equipment control and operations.  
Rule 450. (1) A particle accelerator shall not be left unattended without locking the  
control panel in a manner which prevents its use by unauthorized individuals.  
(2) A mobile or portable particle accelerator shall not be left unattended without  
locking the room or building in which it is housed in a manner which prevents its  
removal by unauthorized persons.  
(3) Access to keys used to comply with the requirements of subrules (1) and (2) of  
this rule shall be limited to specific individuals authorized by the radiation protection  
supervisor.  
(4) Only a switch on the accelerator control console shall be routinely used to turn the  
accelerator beam on and off. The safety interlock system shall not be used to turn off the  
accelerator beam except in an emergency or during periodic testing of the interlock  
system.  
(5) All safety and warning devices, including interlocks, shall be checked for proper  
operability at least quarterly. Results of these tests shall be maintained for inspection by  
the department at the accelerator installation.  
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(6) Electrical circuit diagrams of the accelerator, and the associated interlock systems,  
shall be kept current and on file at each  
accelerator installation.  
(7) If it is necessary to intentionally bypass a safety interlock or interlocks, the action  
shall be in conformance with all of the following:  
(a) Authorized by the radiation protection supervisor pursuant to R 333.5075.  
(b) Recorded in a permanent log and a notice posted at the accelerator control  
console.  
(c) Terminated as soon as possible.  
(8) A copy of the operating and the emergency procedures shall be maintained at the  
accelerator control panel.  
History: 2016 AACS.  
R 333.5452 Radiation surveys.  
Rule 452. (1) A registrant shall maintain at each accelerator installation or class D  
operation appropriate calibrated and operable portable radiation monitoring instruments  
to make physical radiation surveys as required by this part and R 333.5051 to  
R 333.5089.  
(2) These instruments shall be capable by design, calibration, and operation of  
measuring the intensity of the various types and energies of radiation produced by the  
accelerator. These instruments shall be tested for proper operation at the beginning of  
each day they are to be used and calibrated at least quarterly.  
(3) During repair or calibration of a radiation monitoring instrument, a spare  
calibrated and operable instrument shall be provided or accelerator operations which  
require the instrument shall be terminated until required instrumentation is available.  
(4) A radiation protection survey shall be performed and documented pursuant to  
R 333.5063 when changes have been made in shielding, operation, equipment, or  
occupancy of adjacent areas.  
(5) Radiation levels in all accessible high radiation areas shall be continuously  
monitored except in installations designed for human exposure. The monitoring devices  
shall be independent and capable of providing a remote and local readout with visual or  
audible alarms, or both, at the control panel and at the monitoring stations.  
(6) All area monitors shall be calibrated at established periodic intervals approved by  
the department.  
(7) All area surveys shall be made as specified in the written procedures established  
by a health physics consultant or the radiation protection supervisor of the accelerator  
facility and approved by the department.  
(8) Records of all radiation protection surveys, calibration results, instrumentation  
tests, and smear results shall be kept current and on file at each accelerator facility.  
History: 2016 AACS.  
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PART 13. MISCELLANEOUS SOURCES  
R 333.5481 Purpose and scope.  
Rule 481. (1) This part establishes radiation safety requirements for miscellaneous  
radiation sources and for persons utilizing sources not exempted under R 333.5015 and  
not specifically covered elsewhere by these rules.  
(2) This part applies to all persons who use sources of radiation not specifically  
covered by the other parts.  
(3) In addition to the requirements of this part all persons and activities covered by  
this part are subject to the applicable provisions of R 333.5001 to R 333.5101.  
History: 2016 AACS.  
ANALYTICAL X-RAY SOURCES  
R 333.5482 X-ray equipment.  
Rule 482. (1) Tube housing leakage from analytical x-ray sources shall not exceed 0.5  
milliroentgen per hour at a 5 centimeter distance from the surface of the tube housing  
with the beam ports blocked and the tube operating at its leakage technique factors. Also,  
radiation originating from the high voltage power supplies shall not exceed this limit.  
(2) For instruments in which the primary x-ray beam is completely enclosed, the  
radiation shall be less than 2 milliroentgens per hour at a distance of 25 centimeters from  
the cabinet surface.  
(3) For enclosed equipment, interlocks shall be provided on all access panels which  
terminate exposure and prevent operation while the panel is removed.  
(4) Open beam analytical x-ray equipment shall meet all of the following:  
(a) X-ray diffraction cameras shall have the appropriate ports arranged so that the  
camera collimating system is in place before the x-ray tube can be energized or the  
shutter can be opened.  
(b) An adapter between the x-ray tube and the collimator of the diffractometer camera  
or other accessory shall provide protection equivalent to that required by subrule (1) of  
this rule.  
(c) Safety interlocks shall not be used as routine cut-off switches during normal  
operation. They shall be operated as safety devices only, and tested periodically. When  
the interlock system terminates the x-ray beam, it shall be necessary to reset the "on"  
switch at the control panel to resume operation.  
(d) Tube head ports which are not in use shall be secured in a closed position and  
interlocked to the x-ray generator or warning system.  
(e) The shutter indicator shall be conspicuously displayed to disclose the "open" or  
"closed" position of the shutter.  
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(f) The instrument shall display a conspicuous warning label such as "CAUTION  
RADIATION  
-
THIS EQUIPMENT PRODUCES X-RADIATION WHEN  
ENERGIZED."  
(g) A red warning light shall indicate "X-RAY ON" when the equipment is producing  
x-rays. Other signal lights or alarms shall operate only to indicate a malfunction which  
may produce a radiation, electrical, or other hazard.  
History: 2016 AACS.  
R 333.5484 Administrative procedures.  
Rule 484. A radiation protection supervisor shall be appointed to be responsible for  
radiation safety. This individual’s primary job duty shall not be operating the x-ray  
equipment. The radiation protection supervisor or designated representative shall do all  
of the following:  
(a) Ensure that operational and maintenance procedures are followed.  
(b) Provide instruction in safety practices for all individuals working with the x-ray  
equipment, and those working in the immediate area or periodically review the safety  
instruction provided for these individuals.  
(c) Maintain a personnel monitoring system, as required by R 333.5487.  
(d) Review, approve, and supervise modifications or replacement of parts for the x-  
ray apparatus.  
(e) Conduct surveys and tests as necessary to certify compliance with these rules,  
including specific registration conditions, and maintain records thereof for examination  
by the department.  
History: 2016 AACS.  
R 333.5485 Operators.  
Rule 485. (1) An individual shall not act as the operator of analytical x-ray equipment  
until he or she has received training in radiation safety and has been approved by the  
radiation protection supervisor or designated representative. The operator shall also  
demonstrate competence in the use of the machine and radiation survey instruments.  
(2) The operator shall be responsible for complying with all procedures associated  
with the x-ray equipment.  
History: 2016 AACS.  
R 333.5486 Operating procedures.  
Rule 486. A set of operating procedures, written in understandable and concise  
language, shall be posted on or adjacent to the machine,.  
History: 2016 AACS.  
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R 333.5487 Personnel monitoring.  
Rule 487. An operator of analytical x-ray equipment having an open-beam  
configuration shall be provided with finger or wrist radiation monitoring devices. An  
analytical x-ray system having an open-beam configuration is one in which an individual  
could accidentally place some part of his or her body in the primary beam path during  
normal operation. An individual coming in contact with equipment capable of exposing a  
major portion of the body shall be required to wear whole-body monitoring equipment at  
all times. Personnel coming in contact with this equipment shall be warned of the nature  
and type of physiological effects that may be expected when overexposed to radiation.  
History: 2016 AACS.  
COLD-CATHODE GAS DISCHARGE TUBES  
R 333.5491 Rules applicable.  
Rule 491. Cold-cathode gas discharge tubes designed to demonstrate the effects of a  
flow of electrons or the production of x-radiation are subject to the requirements of  
R 333.5492 to R 333.5495.  
History: 2016 AACS.  
R 333.5492 Exposure rate limit.  
Rule 492. (1) Radiation exposure rates produced by cold-cathode gas discharge tubes  
shall not exceed 10 mR/hr at a distance of 30 centimeters from a point on the external  
surface of the tube, as measured pursuant to R 333.5493.  
(2) The divergence of the exit beam from tubes designed primarily to demonstrate the  
effects of x-radiation, with the beam blocking device in the open position, shall not  
exceed π (Pi) steradians.  
History: 2016 AACS.  
R 333.5493 Measurements.  
Rule 493. (1) Compliance with the exposure rate limit specified in R 333.5492 (1)  
shall be determined by measurements averaged over an area of 100 square centimeters  
with no linear dimension exceeding 20 centimeters.  
(2) Measurements of exposure rates from tubes in enclosures from which the tubes  
cannot be removed without destroying the function of the tube may be made at a distance  
of 30 centimeters from a point on the external surface of the enclosure under either of the  
following conditions:  
(a) In the case of enclosures containing tubes designed primarily to demonstrate the  
production of x-radiation, measurements shall be made with a beam blocking device in  
the beam blocking position.  
(b) In the case of enclosures containing tubes designed primarily to demonstrate the  
effects of a flow of electrons, measurements shall be made with all movable or removable  
parts of the enclosure in the position which would maximize external exposure levels.  
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History: 2016 AACS.  
R 333.5494 Test conditions.  
Rule 494. (1) Measurements shall be made under the conditions of use specified in  
instructions provided by the manufacturer.  
(2) Measurements shall be made with the tube operated under forward and reverse  
polarity.  
History: 2016 AACS.  
R 333.5495 Instructions; labels and warnings.  
Rule 495. (1) For each tube to which R 333.5492 to R 333.5495 are applicable, the  
registrant shall ensure the availability of appropriate safety instructions and instructions  
for the use of the tube. These instructions shall include the specification of a power  
source for use with the tube.  
(2) An enclosure or tube shall have tags or labels inscribed on or permanently affixed  
, which identify the intended polarity of the terminals and shall include either of the  
following:  
(a) In the case of tubes designed primarily to demonstrate the heat effect, fluorescence  
effect, or magnetic effect, a warning that application of power in excess of that specified  
may result in the production of x-rays in excess of allowable limits.  
(b) In the case of tubes designed primarily to demonstrate the production of x-  
radiation, a warning that this device produces x-rays when energized.  
(3) The tag or label required by subrule (2) of this rule shall be located on the tube or  
enclosure so as to be readily visible and legible when the product is fully assembled for  
use.  
History: 2016 AACS.  
ELECTRON MICROSCOPES  
R 333.5505 Equipment.  
Rule 505. (1) During all phases of operation of an electron microscope at the  
maximum rated continuous tube current for the maximum rated peak tube potential the  
radiation exposure rate as measured in air at a distance of 5 centimeters from an  
accessible point on the external surface of the microscope shall not exceed 0.5  
milliroentgen per hour.  
(2) Interlocks shall be provided on all potential radiation hazard access panels which  
terminate exposure and prevent operation while the panel is removed.  
(3) The instrument shall display a conspicuous warning label such as “CAUTION  
RADIATION  
-
THIS EQUIPMENT PRODUCES X-RADIATION WHEN  
ENERGIZED.”  
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(4) Electron microscopes that are not capable of exceeding an operating potential of  
50 kilovolts are exempt from the requirements of R 333.5505 to R 333.5508.  
History: 2016 AACS.  
R 333.5506 Administrative procedures.  
Rule 506. A radiation protection supervisor shall be appointed to be responsible for  
radiation safety. This individual shall not normally operate the electron microscope. The  
radiation protection supervisor or a designated representative shall do all of the  
following:  
(a) Ensure that operational and maintenance procedures are followed.  
(b) Provide instruction in safety practices for all persons working with the electron  
microscope, and those working in the immediate area.  
(c) Maintain a personnel monitoring system, if provided.  
(d) Review, approve, and supervise modifications or replacement of parts for the  
electron microscope.  
(e) Conduct surveys and tests as necessary to certify compliance with these rules,  
including specific registration conditions.  
(f) Maintain records of surveys and tests for examination by the department.  
History: 2016 AACS.  
R 333.5507 Operators.  
Rule 507. (1) An individual shall not act as operator of an electron microscope unless  
he or she has demonstrated to the satisfaction of the radiation protection supervisor or  
designated representative both of the following:  
(a) Competence in the safe use of the instrument.  
(b) Awareness of the potential radiation hazard which could result from improper  
adjustment or misuse of the instrument.  
(2) The operator shall be responsible for complying with all procedures associated  
with the instrument.  
History: 2016 AACS.  
R 333.5508 Operating procedures.  
Rule 508. A set of operating procedures, written in understandable and concise  
language shall be posted on or adjacent to the electron microscope.  
History: 2016 AACS.  
OTHER MISCELLANEOUS SOURCES  
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R 333.5511 Registration conditions.  
Rule 511. Types of radiation sources and uses not specifically covered by these rules  
shall be subject to specific requirements designated by the department in the form of  
registration conditions for the protection of public health, safety, and property until these  
rules are amended to specifically cover these sources and uses.  
History: 2016 AACS.  
PART 14. MAMMOGRAPHY  
GENERAL PROVISIONS  
R 333.5601 Purpose and scope.  
Rule 601. (1) This part establishes requirements governing the use of x-radiation for  
mammography and applies to all persons who use x-radiation for mammography for the  
intentional exposure of humans. A person shall not use a radiation machine to perform  
mammography unless the radiation machine is registered with the department pursuant to  
R 333.5031 to R 333.5049 and is authorized pursuant to the act to perform  
mammography.  
(2) In addition to the requirements of this part, all persons are subject to all applicable  
provisions of these rules.  
(3) A facility shall not misrepresent to its employees, to the public, or to the  
department its status with respect to accreditation of the mammography equipment by the  
American college of radiology, department authorization to perform mammography, or  
compliance with department rules.  
History: 2016 AACS.  
R 333.5602 Adoption by reference.  
Rule 602. Some of these rules refer to all or parts of the following nationally  
recognized standards, which are adopted by reference and identified by date:  
(a) Standards of the United States department of health & human services,  
title 21 - food and drugs, part 900 - mammography. These standards are available for no  
cost from either of the following sources:  
(i) The website of the Michigan department of licensing and regulatory affairs,  
radiation safety section at http://www.michigan.gov/rss.  
(ii) The website of the United States department of health & human services,  
mammography quality standards act and program at http://www.fda.gov/Radiation-  
EmittingProducts/MammographyQualityStandardsActandProgram/default.htm.  
(b) The regulations in 21 C.F.R. 1020.30, “Diagnostic x-ray systems and their major  
components” (April 2007), and 21 C.F.R. 1020.31, “Radiographic equipment”  
(June 2005). These regulations are available for no cost from either of the following  
sources:  
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(i) The website of the Michigan department of licensing and regulatory affairs,  
radiation safety section at http://www.michigan.gov/rss.  
(ii) The website of the United States department of health & human services, U.S.  
food  
and  
drug  
administration  
at  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.  
(c) Criteria of the American college of radiology, “Mammography Accreditation  
Program Requirements” (January 2014), and “Stereotactic Breast Biopsy Accreditation  
Program Requirements” (July 2013). These criteria are available for no cost from either  
of the following sources:  
(i) The website of the Michigan department of licensing and regulatory affairs,  
radiation safety section at http://www.michigan.gov/rss.  
(ii) The website of the American college of radiology at http://www.acr.org.  
History: 2016 AACS.  
R 333.5603 Definitions.  
Rule 603. (1) As used in this part the definitions in 21 C.F.R. 900.2, “Definitions”  
(2002), are adopted by reference with the exception of the definition of “mammography.”  
(2) As used in this part the following definitions apply:  
(a) “Interpreting physician” means a physician who interprets mammograms and who  
meets the requirements of R 333.5627 to R 333.5629.  
(b) "Mammography" means radiography of the breast for the purpose of enabling a  
physician to determine the presence, size, location, and extent of cancerous or potentially  
cancerous tissue in the breast. Mammography includes interventional mammography.  
(c) “Stereotactic breast biopsy” means the imaging of a breast performed in at least 2  
planes to localize a target lesion during invasive interventions for biopsy procedures.  
(d) “Stereotactic breast biopsy physician” means a physician who conducts  
stereotactic breast biopsy.  
History: 2016 AACS.  
R 333.5604 Department inspections.  
Rule 604. (1) The department shall inspect a mammography machine and system not  
later than 60 days after initial mammography authorization is issued. After that initial  
inspection, the department shall annually inspect the mammography machine and system.  
The department may inspect more frequently than annually.  
(2) After a satisfactory inspection by the department, the department shall issue a  
certificate of radiation machine inspection which identifies the facility and the machine  
inspected and which provides a record of the date that the machine was inspected. The  
facility shall conspicuously post the certificate on or near the inspected machine and in a  
location that is observable by patients.  
(3) The department may issue a notice of violations certificate if violations found  
during an inspection are not corrected within the specified time limit or if the department  
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has not received written verification of corrections within the specified time limit. The  
notice of violations certificate shall be conspicuously posted on or near the inspected  
machine and in a location observable by patients.  
(4) A facility shall remove the certificate of radiation machine inspection if directed  
by the department due to subsequent failure to comply with these rules as determined by  
follow-up inspections by the department.  
(5) In conducting inspections, the department shall have access to all equipment,  
materials, records, personnel, and information that the department considers necessary to  
determine compliance with these rules. The department may copy, or require the facility  
to submit to the department, any of the materials, records, or information considered  
necessary to determine compliance with these rules.  
(6) The department shall designate department employees to conduct regulatory  
inspections.  
(7) The department may conduct tests and evaluations as the department considers  
appropriate to determine compliance with all of the provisions of these rules.  
History: 2016 AACS.  
MAMMOGRAPHY AUTHORIZATION  
R 333.5605 Standards for authorization.  
Rule 605. The department shall issue a 3-year mammography authorization if the  
mammography facility is in compliance with all of the following standards:  
(a) The radiation machine meets any of the following requirements:  
(i) The machine and the facility in which the machine is used meet the criteria for the  
American college of radiology mammography accreditation program dated January 2014,  
and the facility submits an evaluation report issued by the American college of radiology  
as evidence that the criteria are met. The criteria are adopted by reference in these rules  
for the purpose of applying this paragraph only.  
(ii) A machine used for stereotactic breast biopsy and the facility in which the  
machine is used meet the criteria of the American college of radiology stereotactic breast  
biopsy accreditation program dated July 2013, and the facility submits an evaluation  
report issued by the American college of radiology as evidence that the criteria are met.  
The criteria are adopted by reference in these rules for the purpose of applying this  
paragraph only. A mammography machine that uses a specially designed add-on device  
for breast biopsy shall be authorized for both mammography and stereotactic breast  
biopsy.  
(iii) The machine is used in a facility that has successfully completed the department's  
evaluation of the items described in R 333.5610.  
(b) The radiation machine, the film or other image receptor used with the machine,  
and the facility where the machine is used meet the requirements of this part and  
applicable provisions of these rules.  
(c) The radiation machine is specifically designed to perform mammography.  
(d) The radiation machine is used exclusively to perform mammography.  
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(e) The radiation machine is used in a facility that, before the machine is used on  
patients and at least annually thereafter, has a qualified medical physicist provide on-site  
consultation to the facility as described in these rules.  
(f) The radiation machine is used according to R 333.5667 or R 333.5690 for  
stereotactic breast biopsy.  
(g) The radiation machine is operated only by an individual who can demonstrate to  
the department that he or she meets the standards described in this part.  
History: 2016 AACS.  
R 333.5606 Temporary mammography authorization.  
Rule 606. (1) The department may issue a nonrenewable temporary mammography  
authorization. A temporary authorization may only be issued if additional time is needed  
to allow the submission of evidence that is satisfactory to the department to demonstrate  
compliance with the provisions of R 333.5605.  
(2) The department may withdraw a temporary authorization before its expiration if  
the radiation machine does not meet 1 or more of the criteria specified in R 333.5605.  
History: 2016 AACS.  
R 333.5607 Application.  
Rule 607. (1) An applicant who seeks mammography authorization shall apply to the  
department using an application form that is supplied by the department. If  
mammography is performed at more than 1 address, a separate application shall be used  
for each address. An applicant shall accurately provide all information that is requested  
on the form. The information submitted as part of the application shall be sufficient, as  
determined by the department, to address all of the standards for authorization.  
Applications that do not provide sufficient information shall be returned to the applicant  
for completion and resubmission. Applications shall include all of the following  
information:  
(a) Information about the facility, including all of the following:  
(i) Mammography facility name, address, and telephone number.  
(ii) Type of practice.  
(iii) The facility registration number, if currently registered.  
(iv) A contact person’s name and telephone number.  
(b) Personnel information, including the education, training, experience, and  
certification of the lead interpreting physician, any qualified medical physicist who  
provides on-site consultation, and any radiologic technologist who performs  
mammography.  
(c) Mammography machine technical information, including all of the following:  
(i) Machine registration number, if currently registered.  
(ii) Manufacturer.  
(iii) Model.  
(iv) Target material.  
(v) Filter material.  
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(d) Imaging system information, including all of the following:  
(i) The type of imaging system being used.  
(ii) Review workstation monitor information, if the machine uses digital imaging.  
(iii) Laser printer information, as applicable, for machines using digital imaging.  
(iv) Film and screen information, if the machine uses screen-film imaging.  
(v) Film processor information, if the machine uses screen-film imaging.  
(e) The date of the most recent medical physicist survey.  
(2) The department shall respond to an application within 30 days after the date of  
receipt of the application.  
History: 2016 AACS.  
R 333.5608 Application fee schedule; waiver.  
Rule 608. (1) An application form for mammography authorization shall be  
accompanied by a nonrefundable payment, in full, by the applicant, for department  
evaluation of compliance with the provisions of R 333.5605(a). The fee schedule is on  
the website of the department.  
(2) If an applicant for mammography authorization submits an evaluation report  
which is issued by the American college of radiology and which demonstrates  
compliance with the provisions of R 333.5605(a), then the fee for department evaluation  
of compliance with the provisions of R 333.5605(a) shall be waived.  
History: 2016 AACS.  
R 333.5609 Application expiration.  
Rule 609. An application for mammography authorization submitted to the  
department shall expire 6 months from the date of the department's receipt of the  
completed application unless the time limit is extended by the department.  
History: 2016 AACS.  
R 333.5610 Supplemental machine information; effect of failure to submit  
information.  
Rule 610. (1) Upon notice from the department that an application for mammography  
authorization is complete and complies with these rules and at the specific request of the  
department, the applicant shall, within 45 days of the department's request, provide all of  
the following information for each radiation machine for which mammography  
authorization is being sought:  
(a) Confirmation that a department-approved mammography phantom is on-site when  
mammography is performed and is used in the facility's ongoing quality control program.  
(b) Processor or laser film printer quality control data and corrective actions, if any,  
taken as a result of that data for a 30-day period beginning after the date the application  
was sent to the department.  
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(c) An x-ray image of a department-approved mammography phantom which is taken  
during the 30-day period for which processor quality control data is required under  
subdivision (b) of this subrule. The phantom image shall be taken using routine machine  
settings being used by the facility for that mammography machine for a 4.2-centimeter  
compressed breast of average density. The phantom image shall be accompanied by  
documentation of the date that the image was taken and the machine settings that were  
used.  
(d) Determinations of the half-value layer, radiation exposure at skin entrance, and  
mean glandular dose. These determinations shall be made with the use of a department-  
approved dosimetry device exposed on the phantom during the same exposure that is  
used to produce an x-ray image to be submitted under subdivision (c) of this subrule, or  
that are made by other methods as specified or approved by the department.  
(e) A set of clinical images produced on or after the date that the application was sent  
to the department. Mammography images shall be without pathology for each of 2  
representative patients, 1 with dense breasts and 1 with fatty breasts. Stereotactic breast  
biopsy images shall be from 1 calcification biopsy case that demonstrates accurate needle  
location and includes the case’s corresponding mammograms. The submitted images  
shall meet all of the following:  
(i) The cases are examples of the facility’s best work.  
(ii) The images are from actual patients.  
(iii) Both screen-film and digital images are labeled with the identification  
information required in R 333.5657 for mammography images or R 333.5683 for  
stereotactic breast biopsy images.  
(iv) The lead interpreting physician reviews and approves the clinical images.  
(f) A copy of the medical physicist’s most recent equipment survey report.  
(2) The department may waive the requirements of subrule (1) of this rule if the  
mammography machine is accredited, or is in the process of becoming accredited, by the  
American college of radiology. To have the requirements of subrule (1) of this rule  
waived, an applicant shall provide, to the department, within 45 days of the department's  
request, copies of the applicant's current accreditation application, current accreditation-  
related correspondence to and from the American college of radiology, or current  
accreditation certificate that is issued by the American college of radiology.  
(3) Failure of an applicant to submit the information required by the provisions of  
either subrule (1) or (2) of this rule within 45 days of the department's request may be  
considered a basis for withdrawal or denial of the mammography authorization, unless  
the time limit is extended by the department for cause.  
History: 2016 AACS.  
R 333.5611 Contracts for technical evaluation.  
Rule 611. (1) In evaluating clinical image quality and acceptability for mammography  
authorization, upon receipt of the information required in R 333.5610(1)(e), the  
department may enter into any necessary contracts with mammography experts, submit  
the images to those experts for technical evaluation, and rely upon their expert evaluation  
in arriving at a department conclusion regarding image quality and acceptability in terms  
of granting or not granting mammography authorization.  
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(2) Technical parameters that are used in evaluating clinical image quality and  
acceptability pursuant to subrule (1) of this rule shall include judgments of all of the  
following:  
(a) Positioning.  
(b) Compression.  
(c) Radiation exposure and dose level.  
(d) Sharpness.  
(e) Contrast.  
(f) Noise.  
(g) Exam identification.  
(h) Artifacts.  
History: 2016 AACS.  
R 333.5612 Notice of change in application information; authorization not  
transferable.  
Rule 612. (1) A facility that is authorized to perform mammography shall notify the  
department, in writing, of any change in the information contained in the application or  
supporting material upon which authorization was granted or any change that affects the  
accuracy of information which is provided or obtained during the application and  
evaluation process for authorization. Changes that shall be reported include changes in  
any of the following:  
(a) Facility ownership.  
(b) Facility location.  
(c) Mammography machine.  
(d) Image modality.  
(e) American college of radiology accreditation status.  
(2) Upon receipt of a notice of change, the department shall advise the facility if  
reapplication for mammography authorization, resubmittal of phantom or clinical images,  
or other actions are considered by the department to be necessary to establish that the  
facility, machine, system, and personnel remain in compliance with the requirements of  
these rules. Upon department request, a facility shall provide any requested information  
or materials within 45 days after the request is made.  
(3) If changes in information are considered to require reapplication for  
mammography authorization, the application shall be filed and processed in the same  
manner as set forth in R 333.5607 and R 333.5608.  
(4) Mammography authorization that is issued by the department is not transferable  
between machines or between persons who own or lease a radiation machine.  
History: 2016 AACS.  
R 333.5613 Authorization withdrawal; reinstatement.  
Rule 613. (1) Three-year mammography authorization is subject to continued  
compliance with this part and the provisions of these rules. Authorization may be  
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withdrawn based on evidence of noncompliance with this part and the provisions of these  
rules pursuant to 1969 PA 306, MCL 24.201 to 24.328.  
(2) If the department withdraws the mammography authorization of a machine, the  
machine shall not be used for mammography. An application for reinstatement of a  
mammography authorization shall be filed and processed in the same manner as an  
application for mammography authorization under R 333.5607 and R 333.5608.  
(3) The department shall not issue a reinstated mammography authorization until the  
department receives the reinspection fee, inspects the machine, and determines that the  
facility meets the standards in R 333.5605.  
History: 2016 AACS.  
PERSONNEL  
R 333.5626 Scope of personnel requirements.  
Rule 626. The requirements of R 333.5627 to R 333.5634 apply to all personnel  
involved in any aspect of mammography, including but not limited to, the production,  
processing, and interpretation of mammograms and related quality assurance activities.  
History: 2016 AACS.  
R 333.5627 Interpreting physician initial qualifications.  
Rule 627. Before beginning to interpret mammograms independently, an interpreting  
physician shall meet all of the following requirements:  
(a) Be licensed as a physician or osteopathic physician under article 15 of the act to  
practice medicine.  
(b) Meet either of the following requirements:  
(i) Be certified in radiology or diagnostic radiology by the American board of  
radiology, the American osteopathic board of radiology, or the royal college of  
physicians and surgeons of Canada; have been eligible for certification in radiology or  
diagnostic radiology for not more than 2 years; or, be certified or determined to be  
qualified in radiology or diagnostic radiology by another professional organization  
determined by the department to have procedures and requirements adequate to ensure  
that physicians certified by the body are competent to interpret radiological procedures,  
including mammography.  
(ii) If the physician has been eligible for certification in radiology or diagnostic  
radiology for less than 2 years, he or she shall have had at least 3 months of documented  
formal training in the interpretation of mammograms and in topics related to  
mammography. The training shall include instruction in radiation physics, including  
radiation physics specific to mammography, radiation effects, and radiation protection.  
The mammographic interpretation component of the training shall be under the direct  
supervision of a physician who meets the requirements of this rule.  
(c) Have a minimum of 60 hours of documented medical education in mammography,  
including instruction in the interpretation of mammograms and education in basic breast  
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anatomy, pathology, physiology, technical aspects of mammography, and quality  
assurance and quality control in mammography. All 60 of these hours shall be category 1  
and at least 15 of the category 1 hours shall have been acquired within the 3 years  
immediately before the date that the physician qualifies as an interpreting physician.  
Hours spent in residency specifically devoted to mammography are considered as  
equivalent to category 1 credits and shall be accepted if documented in writing by the  
appropriate representative of the training institution. A physician who meets the board  
certification requirements of subdivision (b)(i) of this rule is deemed to have met this  
requirement.  
(d) Have interpreted or multi-read at least 240 mammographic examinations within  
the 6-month period immediately before the date that the physician qualified as an  
interpreting physician. The interpretation or multi-reading shall be under the direct  
supervision of an interpreting physician. A physician who becomes appropriately board  
certified at the first allowable time, as defined by an eligible certifying body, shall have  
interpreted or multi-read at least 240 mammographic examinations under the direct  
supervision of an interpreting physician in any 6-month period during the last 2 years of a  
diagnostic radiology residency.  
A physician who was qualified to interpret  
mammograms before the effective date of this rule is considered to have met the  
requirements of this subdivision.  
History: 2016 AACS.  
R 333.5628 Interpreting physician continuing experience and education.  
Rule 628. An interpreting physician shall maintain his or her qualifications by  
meeting the continuing experience and education requirements of 21 C.F.R.  
900.12(a)(1)(ii), “Personnel – Interpreting physicians – Continuing experience and  
education” (2000).  
History: 2016 AACS.  
R 333.5629 Interpreting physician reestablishment of qualifications.  
Rule 629. An interpreting physician who failed to maintain the required continuing  
experience or continuing education requirements of R 333.5628 shall reestablish his or  
her qualifications before resuming the independent interpretation of mammograms by  
meeting the reestablishing qualifications requirements of 21 C.F.R. 900.12(a)(1)(iv),  
“Personnel – Interpreting physicians – Reestablishing qualifications” (2000).  
History: 2016 AACS.  
R 333.5630 Radiologic technologists.  
Rule 630. All mammographic examinations shall be performed by a radiologic  
technologist who meets the general requirements, mammography requirements,  
continuing education requirements, and continuing experience requirements of 21 C.F.R.  
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900.12(a)(2), “Radiologic technologists” (2000), with the exception of 21 C.F.R.  
900.12(a)(2)(i)(A).  
History: 2016 AACS.  
R 333.5634 Medical physicists.  
Rule 634. A medical physicist who conducts surveys of mammography facilities and  
provides oversight of a facility’s quality assurance program shall meet the initial  
qualifications, continuing qualifications, and reestablishing qualification requirements of  
21 C.F.R. 900.12(a)(3), “Medical physicists” (2000).  
History: 2016 AACS.  
R 333.5635 Retention of personnel records.  
Rule 635. A mammography facility shall maintain records to document the  
qualifications of all personnel who work at the facility as interpreting physicians,  
radiologic technologists, or medical physicists. These records shall be made available for  
review during department inspections. Records of personnel no longer employed by the  
mammography facility shall be kept on file until the next inspection following the  
employee’s termination has been completed, and the department determines that the  
facility complies with the personnel requirements.  
History: 2016 AACS.  
X-RAY EQUIPMENT  
R 333.5637 X-ray equipment; requirements.  
Rule 637. (1) The mammographic x-ray equipment shall be maintained in  
compliance with the applicable regulations in 21 C.F.R. 1020.30, “Diagnostic x-ray  
systems and their major components” (2007), and 21 C.F.R. 1020.31, “Radiographic  
equipment” (2005).  
(2) The mammography machine, x-ray film, intensifying screens, film processing  
solutions, film illumination, and film masking devices shall meet the requirements of 21  
C.F.R. 900.12(b), “Equipment” (2000).  
History: 2016 AACS.  
R 333.5655 Enclosure requirements; use of mobile equipment.  
Rule 655. (1) A fixed x-ray equipment enclosure shall meet the requirements of  
R 333.5331.  
(2) For mammography, the operator's barrier shall provide radiation protection that is  
equivalent to not less than 0.5 millimeter of lead when the maximum tube potential is less  
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than or equal to 35 kilovolts and 0.8 millimeter of lead when the maximum tube potential  
is greater than 35 kilovolts.  
(3) An individual operating a mobile or portable mammography machine shall wear a  
protective apron of a minimum 0.5 millimeter lead equivalence unless shielding is  
provided as specified in subrule (2) of this rule.  
(4) Mobile or portable mammography equipment used routinely in 1 location shall be  
considered a fixed installation and shall meet the requirements of R 333.5331.  
(5) Mobile or portable mammography equipment shall not be used for routine  
mammography in hospitals or private offices of practitioners of the healing arts. This  
equipment shall be used only when it is medically inadvisable to move a patient to a fixed  
mammographic installation.  
History: 2016 AACS.  
R 333.5656 Conditions of operation.  
Rule 656. The operation of a mammography x-ray machine shall meet the  
requirements of R 333.5333.  
History: 2016 AACS.  
MEDICAL RECORDS AND MAMMOGRAPHY REPORTS  
R 333.5657 Medical records and mammography reports.  
Rule 657. A mammography facility shall comply with 21 C.F.R. 900.12(c), “Medical  
records and mammography reports” (2000), except that the reference to retention of  
records in 21 C.F.R. 900.12(c)(4)(i) is changed from “not less than 5 years” to “not less  
than 7 years” pursuant to MCL 333.20175.  
History: 2016 AACS.  
QUALITY ASSURANCE  
R 333.5658 Quality assurance - general.  
Rule 658. A mammography facility shall comply with 21 C.F.R. 900.12(d), “Quality  
assurance general” (2000).  
History: 2016 AACS.  
R 333.5667 Quality assurance – equipment.  
Rule 667. A mammography facility shall comply with 21 C.F.R. 900.12(e), “Quality  
assurance – equipment” (2000).  
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History: 2016 AACS.  
R 333.5668 Quality assurance - mammography medical outcomes audit;  
mammographic procedure and techniques for mammography of patients with  
breast implants; consumer complaint mechanism; clinical image quality.  
Rule 668. A mammography facility shall comply with 21 C.F.R. 900.12(f), “Quality  
assurance – mammography medical outcomes audit” (2000); 21 C.F.R. 900.12(g),  
“Mammographic procedure and techniques for mammography of patients with breast  
implants” (2000); 21 C.F.R. 900.12(h), “Consumer complaint mechanism” (2000) and  
21 C.F.R. 900.12(i), “Clinical image quality” (2000).  
History: 2016 AACS.  
R 333.5669 Alternative requirements for personnel, x-ray equipment, medical  
records and mammography reports, and quality assurance.  
Rule 669. The department may accept alternatives to a quality standard under  
21 C.F.R. 900.12 that have been approved by the U.S. food and drug administration  
under 21 C.F.R. 900.18, “Alternative requirements for § 900.12 quality standards”  
(2000).  
History: 2016 AACS.  
STEREOTACTIC BREAST BIOPSY  
PERSONNEL  
R 333.5674 Radiologic technologists.  
Rule 674. All stereotactic breast biopsy procedures shall be performed by a  
radiologic technologist who meets all of the following requirements:  
(a) Initial qualifications. Before beginning to perform stereotactic breast biopsy  
procedures independently, a technologist shall do all of the following:  
(i) Meet the requirements of R 333.5630.  
(ii) Have 3 hours of category A continuing education units in stereotactic breast  
biopsy.  
(iii) Have performed 5 stereotactic breast biopsy procedures under supervision of a  
stereotactic breast biopsy physician or a qualified stereotactic breast biopsy technologist.  
(b) Continuing experience. Following the second anniversary date of the end of the  
calendar quarter in which the initial qualifications of subdivision (a) of this rule were  
completed, the stereotactic breast biopsy technologist shall have performed at least 24  
stereotactic breast biopsy procedures during the 24 months immediately preceding the  
date of the facility's annual inspection or the last day of the calendar quarter preceding the  
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inspection or any date in between the 2. The facility shall choose 1 of these dates to  
determine the 24-month period.  
(c) Continuing education. A technologist shall comply with the requirements of the  
American registry of radiologic technologists for continuing education for the imaging  
modality in which he or she performs services. The continuing education shall include  
credits pertinent to stereotactic breast biopsy.  
History: 2016 AACS.  
R 333.5675 Medical physicists.  
Rule 675. A stereotactic breast biopsy medical physicist shall meet all of the  
following requirements:  
(a) Initial qualifications. Before independently performing surveys of stereotactic  
breast biopsy facilities a medical physicist shall have complied with all of the following:  
(i) Met the requirements of R 333.5634.  
(ii) Have performed 1 hands-on stereotactic breast biopsy physics survey under a  
qualified stereotactic breast biopsy medical physicist or 3 independent stereotactic breast  
biopsy surveys before April 17, 2013.  
(b) Continuing experience. Following the second anniversary date of the end of the  
calendar quarter in which the initial qualifications of subdivision (a) of this rule were  
completed, the stereotactic breast biopsy medical physicist shall have performed at least 2  
stereotactic breast biopsy physics surveys during the 24 months immediately preceding  
the date of the facility's annual inspection or the last day of the calendar quarter preceding  
the inspection or any date in between the 2. The facility shall choose 1 of these dates to  
determine the 24-month period.  
(c) Continuing education. Following the third anniversary date of the end of the  
calendar quarter in which the initial qualifications of subdivision (a) of this rule were  
completed, the stereotactic breast biopsy medical physicist shall have completed at least 3  
continuing medical education credits in stereotactic breast biopsy during the 36 months  
immediately preceding the date of the facility's annual inspection or the last day of the  
calendar quarter preceding the inspection or any date in between the 2. The facility shall  
choose 1 of these dates to determine the 36-month period.  
History: 2016 AACS.  
X-RAY EQUIPMENT  
R 333.5676 Equipment requirements.  
Rule 676. (1) The mammographic x-ray equipment shall be maintained in  
compliance with the applicable regulations in 21 C.F.R. 1020.30, “Diagnostic x-ray  
systems and their major components” (2007), and 21 C.F.R. 1020.31, “Radiographic  
equipment” (2005).  
(2) A machine that is used for stereotactic breast biopsy shall be 1 of the following:  
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(a) A radiation machine that is specifically designed to perform stereotactic breast  
biopsy.  
(b) A mammography machine with a specially designed add-on device for breast  
biopsy.  
(c) A mammography machine that exclusively uses lateral arm devices if the needle  
can be seen in 2 ways in relation to the target lesion.  
History: 2016 AACS.  
R 333.5677 Enclosures; use of mobile equipment.  
Rule 677. (1) A fixed x-ray equipment enclosure shall comply with R 333.5331.  
(2) For stereotactic breast biopsy, the operator's barrier shall provide radiation  
protection that is equivalent to not less than 0.5 millimeter of lead when the maximum  
tube potential is less than or equal to 35 kilovolts and 0.8 millimeter of lead when the  
maximum tube potential is greater than 35 kilovolts.  
(3) An individual operating mobile or portable stereotactic breast biopsy equipment  
shall wear a protective apron of a minimum 0.5 millimeter lead equivalence unless  
shielding is provided as specified in subrule (2) of this rule.  
(4) Mobile or portable stereotactic breast biopsy equipment used routinely in 1  
location shall be considered a fixed installation and shall comply with the requirements of  
R 333.5331.  
(5) Mobile or portable stereotactic breast biopsy equipment shall not be used for  
routine mammography in hospitals or private offices of physicians or osteopathic  
physicians. This equipment shall be used only when it is medically inadvisable to move a  
patient to a fixed mammographic installation.  
History: 2016 AACS.  
R 333.5678 Conditions of operation.  
Rule 678. The operation of a mammography x-ray machine shall comply with  
R 333.5333.  
History: 2016 AACS.  
MEDICAL RECORDS AND STEREOTACTIC BREAST BIOPSY REPORTS  
R 333.5679 Report contents.  
Rule 679. A stereotactic breast biopsy facility shall prepare a written report of the  
results of each stereotactic breast biopsy procedure. The stereotactic breast biopsy report  
shall include all of the following information:  
(a) The name of the patient and an additional unique patient identifier.  
(b) The date of the procedure.  
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(c) The name of the stereotactic breast biopsy physician who conducted the  
procedure.  
(d) The procedure performed.  
(e) Designation of the left or right breast.  
(f) Description and location of the lesion.  
History: 2016 AACS.  
R 333.5681 Communication of stereotactic breast biopsy results to health care  
providers.  
Rule 681. When a patient has a referring health care provider or a patient has named  
a health care provider, the stereotactic breast biopsy facility shall provide a written report  
of the stereotactic breast biopsy procedure, including the items listed in R 333.5679, to  
that health care provider not later than 30 days after the date that the stereotactic breast  
biopsy procedure was performed.  
History: 2016 AACS.  
R 333.5682 Record keeping.  
Rule 682. (1) A facility that performs stereotactic breast biopsy procedures shall  
comply with both of the following:  
(a) Maintain stereotactic breast biopsy images and reports in a permanent medical  
record of the patient for a period of not less than 7 years, or not less than 10 years if no  
additional stereotactic breast biopsy procedures of the patient are performed at the  
facility.  
(b) Upon request by, or on behalf of, a patient, permanently or temporarily transfer  
the original stereotactic breast biopsy images and copies of the patient's reports to any of  
the following:  
(i) A medical institution.  
(ii) A patient’s physician.  
(iii) The patient directly.  
(2) Any fee a facility charges a patient for providing the services specified in subrule  
(1)(b) of this rule shall not exceed the documented costs associated with this service.  
History: 2016 AACS.  
R 333.5683 Stereotactic breast biopsy image identification.  
Rule 683. A stereotactic breast biopsy image shall have the following information  
indicated on it in a permanent, legible, and unambiguous manner and placed so as not to  
obscure anatomic structures:  
(a) Name of patient and an additional unique patient identifier.  
(b) Date of the procedure.  
(c) Designation of left or right breast.  
(d) Cassette identification, if applicable.  
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(e) Stereotactic breast biopsy unit identification if there is more than 1 unit in the  
facility.  
History: 2016 AACS.  
QUALITY ASSURANCE  
R 333.5684 Quality assurance – general.  
Rule 684. A stereotactic breast biopsy facility shall establish and maintain a quality  
assurance program to ensure the safety, reliability, clarity, and accuracy of stereotactic  
breast biopsy services performed at the facility.  
History: 2016 AACS.  
R 333.5685 Responsible individuals.  
Rule 685. Responsibility for the quality assurance program and for each of its  
elements shall be assigned to the following individuals who are qualified for their  
assignments:  
(a) Lead stereotactic breast biopsy physician. The facility shall identify a lead  
stereotactic breast biopsy physician who shall be responsible for ensuring that the quality  
assurance program meets all requirements of R 333.5684 to R 333.5697. No other  
individual shall be assigned or shall retain responsibility for quality assurance tasks  
unless the lead stereotactic breast biopsy physician has determined that the individual is  
qualified to perform the assignment.  
(b) Stereotactic breast biopsy physicians. All stereotactic breast biopsy physicians  
conducting stereotactic breast biopsy procedures for the facility shall follow the facility’s  
procedures for corrective action when the images they are asked to interpret are of poor  
quality.  
(c) Medical physicist. The facility shall have the services of a medical physicist  
available to survey stereotactic breast biopsy equipment and oversee the equipment-  
related quality assurance practices of the facility. The medical physicist shall be  
responsible for performing the surveys and stereotactic breast biopsy equipment  
evaluations and providing the facility with the reports described in R 333.5693 and  
R 333.5694.  
(d) Quality control technologist. Responsibility for tasks within the quality assurance  
program not assigned to the lead stereotactic breast biopsy physician or the medical  
physicist shall be assigned to a quality control technologist. The tasks are to be performed  
by the quality control technologist, but may be delegated to other qualified personnel by  
the quality control technologist. When other personnel are utilized for these tasks, the  
quality control technologist shall ensure that they were completed in compliance with  
R 333.5687.  
History: 2016 AACS.  
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Editor's Note: An obvious error in R 325.5685 was corrected at the request of the promulgating  
agency, pursuant to Section 56 of 1969 PA 306, as amended by 2000 PA 262, MCL 24.256. The rule  
containing the error was published in Michigan Register, 2016 MR 10. The memorandum requesting the  
correction was published in Michigan Register, 2016 MR 16.  
R 333.5686 Quality assurance records.  
Rule 686. (1) The lead stereotactic breast biopsy physician, quality control  
technologist, and medical physicist shall ensure that records concerning the following  
items are properly maintained and updated:  
(a) Stereotactic breast biopsy techniques and procedures.  
(b) Quality control, including monitoring data and corrective actions taken.  
(c) Safety.  
(d) Employee qualifications to meet assigned quality assurance tasks.  
(2) The quality assurance records specified in subrule (1) of this rule shall be kept for  
each test specified in R 333.5684 to R 333.5697 until the next annual inspection has been  
completed and the department has determined that the facility is in compliance with the  
quality assurance requirements, or until the test has been performed 2 additional times at  
the required frequency, whichever is longer.  
History: 2016 AACS.  
R 333.5687 Radiologic technologist quality control tests.  
Rule 687. A stereotactic breast biopsy facility shall have a radiologic technologist  
perform the following quality control tests at the intervals specified in this rule:  
(a) A localization accuracy test shall be performed daily before the equipment is used  
on patients. Each of the indicated needle tip coordinates shall be within 1 millimeter of  
the actual preset needle tip location.  
(b) A phantom image evaluation shall be performed at least weekly. The phantom  
image shall achieve at least the minimum score established in R 333.5689.  
(c) A hard copy output quality test shall be performed at least monthly, if hard copies  
are produced from digital data.  
(d) A compression test shall be performed at least semiannually. The maximum  
compression force for the power drive mode shall be between 25 pounds and 45 pounds.  
(e) A repeat analysis shall be performed at least semiannually. If the overall repeat or  
reject rate exceeds 20% based on an image volume of not less than 150 patients, the  
reason for the change shall be determined. A repeat analysis shall be assessed  
semiannually even if fewer than 150 patients are examined during that period.  
(f) If stereotactic breast biopsy is performed using a screen-film system, the  
following tests shall be required:  
(i) A processor quality control test shall be performed at least daily. Film processors  
used to develop stereotactic breast biopsy films shall be adjusted and maintained to meet  
the technical development specifications for the mammography film in use. A processor  
performance test shall be performed at the beginning of each operational day before  
processing any clinical images. The test shall use the mammography film used clinically  
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at the facility and shall include an assessment of base plus fog density, mid-density, and  
density difference as follows:  
(A) The base plus fog density shall be within 0.03 of the established operating level.  
(B) The mid-density shall be within plus or minus 0.15 of the established operating  
level.  
(C) The density difference shall be within plus or minus 0.15 of the established  
operating level.  
(ii) An analysis of fixer retention in film assessed at least quarterly. The residual  
fixer shall be not more than 5 micrograms per square centimeter.  
(iii) A screen-film contact test shall be performed at least semiannually. Testing for  
screen-film contact shall be conducted using 40 mesh copper screen. All cassettes used  
in the facility for stereotactic breast biopsy shall be tested.  
(iv) A test of darkroom fog shall be performed at least semiannually. The optical  
density attributable to darkroom fog shall not exceed 0.05 when a mammography film of  
the type used in the facility, which has a mid-density of not less than 1.2 optical density,  
is exposed to typical darkroom conditions for 2 minutes while the film is placed on the  
counter top emulsion side up.  
History: 2016 AACS.  
R 333.5688 Annual medical physicist’s quality control tests.  
Rule 688. Before the radiation machine is used on patients and at least annually  
thereafter, a stereotactic breast biopsy facility shall have the medical physicist perform  
all of the following quality control tests:  
(a) Collimation assessment that meets either of the following:  
(i) For screen-film systems, the x-ray field shall be contained within the image  
receptor on all 3 sides except the chest wall edge. The x-ray field shall not extend  
beyond the chest wall edge of the image receptor by more than 2% of the source-image  
receptor distance.  
(ii) For digital image receptors, the x-ray field may extend beyond the edge of the  
image receptor on all 4 sides, but no edge of the x-ray field shall extend beyond the  
image receptor by more than 5 millimeters on any side. Distances shall be measured in,  
or referred to, the plane of the digital image receptor.  
(b) Focal spot performance and system limiting spatial resolution. Assess consistency  
of system-limiting resolution over time and in comparison to acceptance testing results  
using a line pair test pattern.  
(c) Peak tube potential (kVp) accuracy and reproducibility. The tube potential shall  
be accurate to within 5% of the indicated or selected potential. The coefficient of  
variation of reproducibility of the potential shall be less than or equal to 0.02 at the most  
commonly used clinical settings.  
(d) Beam quality assessment. The half-value layer shall be greater than or equal to  
the value kVp/100 in units of millimeter of aluminum.  
(e) Automatic exposure control system or manual exposure performance assessment  
that meets either of the following:  
(i) For screen-film systems, the image optical density shall be within 0.15 of the mean  
optical density when thicknesses of a homogeneous material is varied over a range of 4 to  
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8 centimeters using the clinical techniques for each thickness. If the optical densities do  
not meet this criterion, the medical physicist shall develop a technique chart which meets  
this criterion.  
(ii) For digital systems, the signal value at the center of the digital field of view shall  
remain within 20% of the signal obtained for the 4 centimeter phantom when thicknesses  
of a homogeneous material is varied over a range of 4 to 8 centimeters using the clinical  
techniques for each thickness. If the signal values do not meet this criterion, the medical  
physicist shall develop a technique chart which meets this criterion.  
(f) Image receptor speed uniformity that meets 1 of the following:  
(i) For screen-film systems, the difference between the maximum and minimum  
optical densities of all the cassettes in the facility shall not exceed 0.30.  
(ii) For digital systems, the signal-to-noise ratios (SNR) measured in each corner of  
the image shall be within 15% of the SNR measured at the center of the field of view.  
(iii) For digital systems that are not equipped with region of interest signal  
measurements, the machine shall meet the receptor uniformity requirements specified by  
the manufacturer.  
(g) Breast entrance exposure, average glandular dose, and exposure reproducibility.  
The coefficient of variation for both air kerma and current-time product (mAs) shall not  
exceed 0.05. The average glandular dose delivered during a single exposure of a  
department-approved phantom simulating a standard breast shall not exceed 3.0  
milligrays (300 millirads) per exposure. The dose shall be determined with technique  
factors and conditions used clinically for a standard breast.  
(h) Image quality evaluation. An image of a department-approved phantom shall  
achieve at least the minimum score established in R 333.5689.  
(i) Artifact evaluation. System artifacts shall be evaluated with a high-grade, defect-  
free sheet of homogeneous material large enough to cover the full area of the exposed  
image receptor on the breast support assembly.  
(j) Localization accuracy test. Using a phantom made of gelatin or similar material,  
the biopsy needle shall capture the intended object in the phantom.  
History: 2016 AACS.  
R 333.5689 Phantom image scores.  
Rule 689. A stereotactic breast biopsy phantom image score for the tests required in  
R 333.5687(b) and R 333.5688(h) shall be not less than the values specified in table 689:  
TABLE 689  
Image  
Standard Mammography Phantom  
Mini Stereotactic Phantom  
System  
Fibers  
Speck  
Groups  
3.0  
Masses  
Fibers  
Speck  
Groups  
2.0  
Masses  
Screen-film  
Digital  
4.0  
5.0  
3.0  
3.5  
2.0  
3.0  
2.0  
2.5  
4.0  
3.0  
History: 2016 AACS.  
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R 333.5690 Dosimetry.  
Rule 690. The average glandular dose delivered during a single exposure of a  
department-approved phantom simulating a standard breast shall not exceed 3.0  
milligrays (300 millirads) per exposure. The dose shall be determined with technique  
factors and conditions used clinically for a standard breast.  
History: 2016 AACS.  
R 333.5691 Quality assurance for mobile units.  
Rule 691. A stereotactic breast biopsy facility shall verify that mammography units  
used to produce interventional mammograms at more than 1 location meet the  
requirements in R 333.5687 to R 333.5690. At each examination location and before any  
examinations are conducted, the facility shall verify satisfactory performance of these  
units by using a test method that establishes the adequacy of the image quality produced  
by the unit.  
History: 2016 AACS.  
R 333.5692 Use of quality assurance test results.  
Rule 692. (1) After completion of tests specified in R 333.5687 to R 333.5691, the  
facility shall compare the test results to the corresponding specified action limits or the  
limits established by the facility to verify the image quality of mobile units following a  
move.  
(2) If the test results fall outside of the action limits, the source of the problem shall  
be identified and corrective actions shall be taken within the following time frames:  
(a) Before any further examinations are performed or any films are processed using a  
component of the mammography system that failed any of the tests described in  
R 333.5687(a),(b),(d),(f)(i), (f)(iii), (f)(iv); R 333.5688(g) and (h); or R 333.5691.  
(b) Within 30 days of the test date for all other tests described in R 333.5687 to  
R 333.5691.  
History: 2016 AACS.  
R 333.5693 Medical physicist surveys.  
Rule 693. (1) A stereotactic breast biopsy facility shall annually undergo a survey by  
a medical physicist or by an individual under the direct supervision of a medical  
physicist. The survey shall include, at a minimum, the performance of tests to ensure that  
the facility meets the quality assurance requirements of the annual tests described in  
R 333.5688 and the weekly phantom image quality test as provided in R 333.5687(b).  
(2) The results of all tests conducted by the facility pursuant to R 333.5687 to  
R 333.5691 and written documentation of any corrective actions taken and their results  
shall be evaluated for adequacy by the medical physicist performing the survey.  
(3) The medical physicist shall prepare a survey report that includes a summary of  
this review and recommendations for necessary improvements.  
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(4) The survey report shall be provided to the facility within 30 days of the date of the  
survey.  
(5) The survey report shall be dated and signed by the medical physicist who  
performed or supervised the survey. If the survey was performed entirely or in part by an  
individual under the direct supervision of the medical physicist, that individual and the  
part of the survey that individual performed shall be identified in the survey report.  
History: 2016 AACS.  
R 333.5694 Mammography equipment evaluations.  
Rule 694. (1) Additional evaluations of stereotactic breast biopsy units or image  
processors shall be conducted when a new unit or processor is installed, a unit or  
processor is disassembled and reassembled at the same or a new location, or major  
components of a stereotactic breast biopsy unit or processor equipment are changed or  
repaired. These evaluations shall be used to determine whether the new or changed  
equipment meets the requirements of R 333.5676 to R 333.5678 and R 333.5687 to  
R 333.5691, as applicable. Problems revealed by the evaluation shall be corrected before  
the new or changed equipment is put into service for procedures or film processing.  
(2) The equipment evaluations specified in subrule (1) of this rule shall be performed  
by a medical physicist or by an individual under the direct supervision of a medical  
physicist.  
History: 2016 AACS.  
R 333.5695 Cleanliness in facilities using screen-film systems.  
Rule 695. (1) A stereotactic breast biopsy facility shall establish and implement  
protocols for maintaining darkroom, screen, and view box cleanliness.  
(2) The facility shall document that all cleaning procedures are performed at the  
frequencies specified in the protocols.  
History: 2016 AACS.  
R 333.5696 Calibration of air kerma measuring instruments.  
Rule 696. Instruments used by a medical physicist in his or her annual survey to  
measure the air kerma or air kerma rate from a stereotactic breast biopsy unit shall be  
calibrated once every 2 years and each time the instrument is repaired. The instrument  
calibration shall be traceable to a national standard and calibrated with an accuracy of  
plus or minus 6% (95% confidence level) in the mammography energy range.  
History: 2016 AACS.  
R 333.5697 Infection control.  
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Rule 697. A stereotactic breast biopsy facility shall establish and comply with  
procedures to be followed for cleaning and disinfecting stereotactic breast biopsy  
equipment after contact with blood or other potentially infectious materials. The  
procedures shall include methods for documenting facility compliance with the infection  
control procedures.  
History: 2016 AACS.  
PART 15. COMPUTED TOMOGRAPHY INSTALLATIONS  
R 333.5701 Purpose and scope.  
Rule 701. (1) This part establishes requirements governing the use of computed  
tomography (CT) scanners by, or on behalf of, a health practitioner licensed under article  
15 of the act.  
(2) This part applies to all registrants who use a CT scanner for the intentional  
exposure of humans for diagnostic imaging.  
(3) A CT scanner is exempt from this part if the scanner meets 1 of the following:  
(a) Generates a peak power of 5 kilowatts or less as certified by the manufacturer.  
(b) Is used only for attenuation corrections and anatomical markers as part of a  
positron emission tomography (PET/CT) or single photon emission computed  
tomography (SPECT/CT) study.  
(c) Is used as a simulator solely for treatment planning purposes in conjunction with a  
megavoltage radiation therapy unit.  
(d) Is used solely for intra-operative guidance tomography.  
(4) In addition to the requirements of this part, all registrants are subject to applicable  
parts of these rules and the certificate of need review standards for computed tomography  
scanner services.  
History: 2016 AACS.  
R 333.5703 Definitions.  
Rule 703. (1) As used in this part the definitions in 21 C.F.R. 1020.33, “Computed  
tomography (CT) equipment” (June 10, 2005), are adopted by reference. Copies of these  
regulations are available for no cost from either of the following sources:  
(a) The website of the Michigan department of licensing and regulatory affairs,  
radiation safety section at http://www.michigan.gov/rss.  
(b) The website of the United States department of health & human services, U.S.  
food and drug administration at  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.  
(2) As used in this part the following definitions apply:  
(a) "Computed tomography (CT)" means the production of a tomogram by the  
acquisition and computer processing of x-ray transmission data. Computed tomography  
includes the capability of producing axial tomograms.  
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(b) "CT medical event" means an unintended event where a physician determines that  
actual damage has occurred to an organ or a physiological system of an individual due to  
or suspected to be due to exposure to diagnostic radiation from a CT scanner.  
(c) "CT scanner" means a CT machine capable of performing CT scans of the head,  
other body parts, or full body patient procedures including PET/CT and SPECT/CT  
scanner hybrids if used for CT only procedures.  
(d) "Medical physicist" means an individual trained in evaluating the performance of  
CT scanners, related equipment, and facility quality assurance programs and who meets  
the requirements in R 333.5707.  
(e) "Positron emission tomography (PET)" means an imaging technique that uses  
positron-emitting radionuclides to produce 3-dimensional images of functional processes  
in the body.  
(f) "Radiologic technologist" means an individual specifically trained in the use of  
radiographic equipment and the positioning of patients for radiographic examinations and  
who meets the requirements in R 333.5705.  
(g) "Single photon emission computed tomography (SPECT)" means an imaging  
technique that uses radionuclides to produce 3-dimentional images of functional  
processes in the body.  
(h) "Tomogram" means the depiction of the attenuation properties of a section  
through a body.  
History: 2016 AACS.  
R 333.5705 CT operators.  
Rule 705. All CT examinations shall be performed by a radiologic technologist who  
meets all of the following requirements or by a physician or osteopathic physician  
licensed under article 15 of the act.  
(a) Initial qualifications.  
Before beginning to perform CT examinations  
independently, a technologist shall meet both of the following:  
(i) Be currently registered by the American registry of radiologic technologists  
(ARRT), the Canadian association of medical radiation technologists (CAMRT), or the  
Nuclear Medicine Technology Certification Board (NMTCB).  
(ii) Document at least 20 hours of training and experience in operating CT equipment,  
radiation physics, and radiation protection or have the advanced certification in computed  
tomography from the ARRT.  
(b) Continuing education. A technologist shall be in compliance with the ARRT  
requirements for continuing education for the imaging modality in which he or she  
performs services. The continuing education shall include credits pertinent to CT.  
History: 2016 AACS.  
R 333.5707 Medical physicist.  
Rule 707. A registrant with 1 or more CT scanners shall employ or contract with a  
medical physicist to review the quality and safety of the operation of the CT scanner.  
The medical physicist shall meet all of the following:  
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(a) Initial qualifications. Before beginning to independently provide consultation to a  
CT facility, a medical physicist shall meet 1 of the following:  
(i) Be certified in diagnostic radiological physics or radiological physics by the  
American board of radiology, or in diagnostic imaging physics by the American board of  
medical physics, or in diagnostic radiology physics by the Canadian college of physicists  
in medicine.  
(ii) Have a graduate degree in medical physics, radiological physics, physics, or other  
relevant physical science or engineering discipline from an accredited institution and  
have formal coursework in the biological sciences with at least 1 course in biology or  
radiation biology and 1 course in anatomy, physiology, or similar topics related to the  
practice of medical physics, and have 3 years of documented experience in a clinical CT  
environment. An accredited institution is a college or university accredited by a regional  
accrediting organization that has been recognized either by the U.S. department of  
education (USDE) or by the council for higher education accreditation (CHEA) or both.  
Individuals with non-U.S. degrees shall provide documentation that their foreign degrees  
are equivalent to those granted from an approved institution in the U.S. and that the  
granting institution is equivalent to a regionally accredited institution in the U.S.  
(b) Continuing experience. Within 24 months following the date when the  
requirements of subdivision (a) of this rule were completed, the medical physicist shall  
have evaluated at least 2 CT scanners in the prior 24-month period.  
(c) Continuing education. Within 36 months following the date when the  
requirements of subdivision (a) of this rule were completed, the medical physicist shall  
have earned at least 15 continuing medical education units, at least half shall be category  
1, in the prior 36-month period. The continuing education shall include credits pertinent  
to CT.  
(d) Reestablishing qualifications. A medical physicist who fails to maintain the  
required continuing experience or continuing education requirements shall reestablish his  
or her qualifications before resuming the independent evaluation of CT scanners and  
facilities, as follows:  
(i) A medical physicist who fails to meet the continuing experience requirements of  
subdivision (b) of this rule shall evaluate a sufficient number of CT scanners, under the  
supervision of a medical physicist, to meet the requirements of subdivision (b) of this  
rule.  
(ii) A medical physicist who fails to meet the continuing education requirements of  
subdivision (c) of this rule shall obtain a sufficient number of additional continuing  
education credits to meet the requirements of subdivision (c) of this rule.  
History: 2016 AACS.  
R 333.5709 Equipment requirements.  
Rule 709. (1) The regulations in 21 C.F.R. 1020.33(c), (d), (f), (g), (h), (i), and (j),  
“Computed tomography (CT) equipment” (June 10, 2005), are adopted by reference.  
Copies of these regulations are available for no cost from either of the following  
sources:  
(a) The website of the Michigan department of licensing and regulatory affairs,  
radiation safety section at http://www.michigan.gov/rss.  
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(b) The website of the United States department of health & human services, U.S.  
food and drug administration at  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm.  
(2) CT equipment shall be maintained in compliance with the requirements of  
subrule (1) of this rule.  
History: 2016 AACS.  
R 333.5711 Enclosures.  
Rule 711. (1) A fixed CT scanner enclosure shall be a permanent part of the building  
or equipment. Portable shields shall not be used for permanent installations.  
(2) The degree of protection required for a CT scanner enclosure shall be determined  
by the workload, use and occupancy factors, and the tube potential, tube current,  
mechanical movement, and distance. The design shall be subject to approval by the  
department.  
(3) Protective barriers shall be provided in the ceiling, floor, and walls of a fixed CT  
scanner enclosure.  
(4) The control panel for a fixed CT scanner shall be shielded by a protective barrier  
which cannot be removed from a protective position between the operator and the  
radiation source during machine operation.  
(5) Movable barriers with electrical interlocks shall not be approved in place of  
compliance with subrule (4) of this rule.  
(6) The operator of a fixed CT scanner shall be able to see and communicate with the  
patient from a shielded position at the control panel. When an observation window is  
provided, it shall have a lead equivalence at least equal to that required of the control  
barrier in which it is installed.  
(7) Mobile or portable CT scanners used routinely in 1 location shall be considered a  
fixed installation and shall meet the requirements of subrules (1) to (6) of this rule.  
History: 2016 AACS.  
R 333.5713 Conditions of operation.  
Rule 713. (1) The CT facility shall establish scanning protocols in consultation with  
the medical physicist.  
(2) The CT operator shall check the display panel before and after performing each  
scan to make sure the amount of radiation delivered is appropriate for the technique and  
individual patient. This may be accomplished by reviewing dose indicator devices, if  
available, or dose indices such as the technique factors. Dose indicators or indices  
outside of expected values shall be documented and reviewed by an interpreting  
physician or medical physicist.  
(3) A fixed CT scanner shall be operated from a shielded position behind a protective  
barrier pursuant to R 333.5711(4).  
(4) Staff personnel routinely working with or around radiation sources shall not be  
required by the registrant to restrain patients during CT examinations. If the procedure is  
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permitted personnel exposure shall not exceed the limits in R 333.5057 to R 333.5059 or  
the procedure is prohibited.  
(5) When a patient must be held in position for CT, mechanical supporting or  
restraining devices shall be used unless contraindicated. If the patient is held by an  
individual, this individual shall wear protective gloves and a protective apron of 0.5  
millimeter minimum lead equivalence and be so positioned that no part of his or her body  
is struck by the useful beam and that his or her body is as far as possible from the edge of  
the useful beam.  
(6) Only individuals whose presence is necessary are allowed in a fixed CT scanner  
room during exposure. Each individual, except the patient, shall be protected by at least  
0.5 millimeter lead equivalent aprons or a whole body protective barrier.  
(7) Personnel monitoring is required in controlled areas for each individual  
occupationally exposed to ionizing radiation from CT scanner equipment. Individual  
monitoring devices shall be permanently assigned to each occupationally exposed  
individual. Monitoring shall be continuous during employment as a radiation worker.  
(8) Personnel exposure records shall be kept on permanent available file at the facility  
where the exposure occurs.  
(9) Monitoring devices used to estimate whole body exposure shall normally be worn  
on the chest or abdomen. Monitoring of all other body parts shall meet the requirements  
of R 333.5065.  
(10) Monitoring devices worn to estimate personnel occupational exposure shall not  
be worn by the individual when he or she is exposed as a patient for a medical or dental  
reason.  
(11) A CT scanner shall not be left unattended without locking the apparatus, room,  
or building in some manner which prevents use of the apparatus by unauthorized persons.  
History: 2016 AACS.  
R 333.5715 Report and notification of CT medical event.  
Rule 715. (1) A CT facility shall report all CT medical events.  
(2) The registrant shall submit a written report to the department within 15 days after  
a physician of the CT facility discovers the CT medical event or within 15 days after the  
CT facility is notified of the CT medical event by another physician, whichever comes  
first.  
(3) The written report shall include all of the following:  
(a) The registrant’s name, address, facility registration number, and machine  
registration tag number as they appear on the registration certificate.  
(b) The name of the physician who determined a CT medical event occurred.  
(c) The dates of occurrence and discovery of the CT medical event.  
(d) A narrative description of the CT medical event.  
(e) The cause of the CT medical event.  
(f) The effect on the individual who received the exposure.  
(g) A narrative detailing corrective action taken or planned to prevent a recurrence.  
(h) Certification that the registrant notified the individual or the individual’s  
responsible relative or guardian and, if not, why not.  
(i) The name and signature of the person preparing the report.  
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(4) The report shall not contain the name of the individual who is the subject of the  
CT medical event or any other information that could lead to identification of the  
individual.  
(5) The registrant shall provide notification of the CT medical event to the referring  
physician and shall notify the individual who is the subject of the CT medical event not  
later than 1 week after its discovery, unless the referring physician personally informs the  
registrant that he or she will inform the individual or that, based on medical judgment,  
telling the individual would be harmful. The notification of the individual who is the  
subject of the CT medical event may be made instead to that individual’s responsible  
relative or guardian. The registrant is not required to notify the individual without first  
consulting the referring physician. If the referring physician or the affected individual  
cannot be reached within 1 week, the registrant shall notify the individual as soon as  
possible thereafter. The registrant shall not delay appropriate medical care for the  
individual, including all necessary remedial care as a result of the CT medical event,  
because of a delay in notification. If a verbal notification is made, the registrant shall  
inform the individual or appropriate responsible relative or guardian that a written  
description of the CT medical event can be obtained from the registrant upon request.  
The registrant shall provide a written description if requested.  
History: 2016 AACS.  
R 333.5717 Quality control program.  
Rule 717. (1) A CT facility shall establish and implement a quality control program  
under the supervision of the medical physicist. The documented program shall include  
evaluation of all of the following:  
(a) Image quality.  
(b) Patient radiation dose.  
(c) Personnel radiation protection.  
(d) Compliance with the provisions of this part.  
(e) Ongoing quality control.  
(2) Evaluations and tests shall be performed following written procedures and  
methods. Corrective action shall be taken and documented according to instructions  
provided by the medical physicist if the results of an evaluation or test fall outside the  
control limits.  
(3) The medical physicist shall determine the frequency of each test and who may  
perform the test. An on-site CT radiologic technologist shall be identified to be  
responsible for the ongoing quality control testing. The tests shall be performed by this  
technologist or by other personnel qualified by training and experience following written  
procedures and methods under subrule (2) of this rule.  
History: 2016 AACS.  
R 333.5719 Initial and annual medical physicist performance evaluations.  
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Rule 719. (1) A medical physicist shall complete an initial performance evaluation of  
the CT scanner before use on human patients and annually thereafter.  
(2) A calibrated dosimetry system shall be used to measure the radiation output of a  
CT scanner. Calibration of the dosimetry system shall be within the preceding 24 months  
and shall be traceable to a national standard as specified in R 333.5012(1).  
(3) A performance evaluation should include the following:  
(a) Alignment light accuracy.  
(b) Alignment of table to gantry.  
(c) Table and gantry tilt.  
(d) Slice localization from scanned projection radiograph.  
(e) Table increment accuracy.  
(f) Slice thickness.  
(g) Image quality, including the following:  
(i) High-contrast resolution.  
(ii) Low-contrast resolution.  
(iii) Image uniformity.  
(iv) Noise.  
(v) Artifact evaluation.  
(h) CT number accuracy and linearity.  
(i) Dosimetry, including the following:  
(i) Dose indicator such as computed tomography dose index (CTDI).  
(ii) Patient radiation dose for representative examinations.  
(j) Safety evaluation, including the following:  
(i) Visual inspection.  
(ii) Audible and visual signals.  
(iii) Posting requirements.  
(iv) Scattered radiation measurements.  
(k) Review of the ongoing quality control program, including test results and  
corrective action.  
(4) The medical physicist shall prepare a report that includes all of the following:  
(a) A summary of the performance evaluation required under subrule (1) of this rule.  
(b) Recommendations for necessary improvements.  
(c) Type of dosimetry system used, including the date of the last calibration.  
(5) The report required under subrule (4) of this rule shall be provided to the CT  
facility within 30 days after completion of the evaluation.  
History: 2016 AACS.  
R 333.5721 Records and report retention.  
Rule 721. A CT facility shall maintain records and reports on file and shall make the  
records and reports available for review by the department as follows:  
(a) Records of personnel no longer employed by the CT facility shall be kept on file  
until the next inspection following the employee’s termination has been completed and  
the department has determined that the facility is in compliance with the CT personnel  
requirements.  
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(b) A report of a CT medical event required under R 333.5715 shall be maintained on  
file for at least 7 years.  
(c) Initial and annual medical physicist performance evaluation reports required under  
R 333.5719(4) shall be maintained on file for at least 5 years.  
(d) Records of the results from the ongoing quality control evaluation required under  
R 333.5717 shall be maintained on file for at least 2 years.  
History: 2016 AACS.  
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