Michigan Administrative Code › Department - Labor and Economic Opportunity › MIOSHA › X-Ray Machine Registration › Ionizing Radiation Rules Governing the Use of Radiation Machines › Part 9 - DENTAL X-RAY INSTALLATIONS › HAND-HELD PORTABLE DENTAL X-RAY SYSTEMS › Section R. 333.5396 - Hand-held portable dental x-ray systems

Current through Vol. 24-12, July 15, 2024
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.