DEPARTMENT OF LABOR AND ECONOMIC OPPORTUNITY  
DIRECTOR’S OFFICE  
IONIZING RADIATION RULES GOVERNING THE USE OF RADIATION  
MACHINES  
Filed with the secretary of state on September 28, 2020  
These rules take effect immediately upon filing with the secretary of state unless adopted  
under section 33, 44, or 45a(6) of the administrative procedures act of 1969, 1969 PA  
306, MCL 24.233, 24.244, or 24.245a. Rules adopted under these sections become  
effective 7 days after filing with the secretary of state.  
(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)  
R 333.5396 of the Michigan Administrative Code is amended, as follows:  
HAND-HELD PORTABLE DENTAL X-RAY SYSTEMS  
R 333.5396 Hand-held portable dental x-ray systems.  
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.  
July 27, 2020  
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(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.  
(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.  
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