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