Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 7 - DEPARTMENT OF HEALTH SERVICES - RADIATION CONTROL › Article 3 - RADIOACTIVE MATERIAL LICENSING › Section R9-7-311 - Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute Commodities, Products, or Devices that Contain Radioactive Material

Current through Register Vol. 30, No. 28, July 12, 2024
A.
				Licensing the manufacture and distribution of devices to persons generally
				licensed under
				R9-7-306(A).
1. The Department shall grant a specific
				license to manufacture or distribute each device that contains radioactive
				material, excluding special nuclear material, to persons generally licensed
				under R9-7-306(A) or
				equivalent regulations of the U.S. NRC, an Agreement State, or the Licensing
				State if:
a. The applicant satisfies the
				requirements of R9-7-309;
b. The
				applicant submits sufficient information relating to the design, manufacture,
				prototype testing, quality control, labels, proposed uses, installation,
				servicing, leak testing, operating and safety instructions, and potential
				hazards of the device to provide reasonable assurance that:
i. The device can be safely operated by
				persons not having training in radiological protection;
ii. Under ordinary conditions of handling,
				storage, and use of the device, the radioactive material contained in the
				device will not be released or inadvertently removed from the device, and it is
				unlikely that any person will receive a dose in excess of 10 percent of the
				limits specified in
				R9-7-408; and
iii. Under accident conditions (such as fire
				and explosion) associated with handling, storage, and use of the device, it is
				unlikely that any person would receive an external radiation dose or dose
				commitment in excess of the following organ doses:
(1) Whole body; head and trunk; active
				blood-forming organs; gonads; or lens of eye: 150 mSv (15 rem)
(2) Hands and forearms; feet and ankles;
				localized areas of skin averaged over areas no larger than 1 square centimeter;
				2 Sv (200 rem)
(3) Other organs:
				500 mSv (50 rem)
c. Each device bears a durable, legible,
				clearly visible label or labels that contain in a clearly identified and
				separate statement:
i. Instructions and
				precautions necessary to assure safe installation, operating, and servicing of
				the device (documents such as operating and service manuals may be identified
				in the label and used to provide this information);
ii. The requirement, or lack of requirement,
				for leak testing, or for testing any on-off mechanism and indicator, including
				the maximum time interval for the testing, and the identification of
				radioactive material by isotope, quantity of radioactivity, and date of
				determination of the quantity; and
iii. The information called for in one of the
				following statements in the same or substantially similar form: The receipt,
				possession, use, and transfer of this device, Model _____ , Serial No. _____ ,
				are subject to a general license or the equivalent and the regulations of the
				U.S. Nuclear Regulatory Commission or a state with which the Nuclear Regulatory
				Commission has entered into an agreement for the exercise of regulatory
				authority. This label shall be maintained on the device in a legible condition.
				Removal of this label is prohibited. CAUTION - RADIOACTIVE MATERIAL
_____________________________________
(name of manufacturer or distributor) The receipt,
				  possession, use and transfer of this device, Model _____ , Serial No. _____ ,
				  are subject to a general license or the equivalent, and the regulations of a
				  Licensing State. This label shall be maintained on the device in a legible
				  condition. Removal of this label is prohibited. CAUTION - RADIOACTIVE
				  MATERIAL
_____________________________________
(name of manufacturer or distributor)
d. The model, serial number, and
				name of manufacturer or distributor may be omitted from the label if the
				information location is specified in labeling affixed to the device;
e. Each device with a separable source
				housing that provides the primary shielding for the source also bears, on the
				source housing, a durable label that provides the device model number and
				serial number, the isotope and quantity, the words, "Caution-Radioactive
				Material," the radiation symbol described in R9-7-428, and the name of the
				manufacturer or initial distributor; and
f. Each device meets the criteria in
				10 CFR
				31.5(c)(13)(i) (revised
				January 1, 2013, incorporated by reference, and available under
				R9-7-101. This incorporated
				material contains no future editions or amendments) and bears a permanent
				(e.g., embossed, etched, stamped, or engraved) label affixed to the source
				housing, if separable, or the device if the source housing is not separable,
				that includes the words, "Caution-Radioactive Material," and, if practicable,
				the radiation symbol described in R9-7-428.
g. The device has been registered in the
				Sealed Source and Device Registry.