459.282 - Specific licenses: Manufacture or distribution of devices

459.282. Specific licenses: Manufacture or distribution of devices

An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under NAC 459.216 or equivalent regulations of the Nuclear Regulatory Commission or an agreement state will be approved if:

1. The applicant satisfies the general requirements of NAC 459.238.

2. 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:

(a) The device can be safely operated by persons not having training in radiological protection;

(b) 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 in any period of 1 year a dose in excess of 10 percent of the limits specified in NAC 459.325; and

(c) In an accident such as fire or 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 .............................................................................................................................. 15 rems

(2) Hands and forearms, feet and ankles, localized areas of skin averaged over areas not larger than 1 square centimeter .......................................................................200 rems

(3) Other organs ...............................................................................................................50 rems

3. Each device bears a durable, legible, clearly visible label or labels approved by the Division which contain in a clearly identified and separate statement:

(a) Instructions and precautions necessary to assure safe installation, operation and maintenance of the device. Documents such as operating and service manuals may be identified in the label and used to provide this information.

(b) The requirement, or lack of requirement, for leak testing, or for testing any on-and-off mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity and date of determination of the quantity.

(c) The information called for in the following statement, in the same or substantially similar form:

The receipt, possession, use and transfer of this device model, serial number, are subject to a general license or the equivalent and the regulations of the Nuclear Regulatory Commission or a state with which the Nuclear Regulatory Commission has entered into an agreement for the exercises of regulatory authority. This label must 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 the manufacturer or distributor may be omitted from the label required by this subsection if the information is specified elsewhere and labeling is affixed to the device.

4. Each device that has a separable source housing that provides primary shielding for the source also bears, on the source housing, a durable label listing the model number and serial number of the device, the isotope and quantity, the radiation symbol described in NAC 459.355, the words "CAUTION - RADIOACTIVE MATERIAL" and the name of the manufacturer or initial distributor of the device.

5. Each device described in paragraph (a) of subsection 13 of NAC 459.218 bears a permanent label, including, without limitation, an embossed, etched, engraved or a stamped label, affixed to the source housing if separable or to the device if the source housing is not separable, which contains the words "CAUTION - RADIOACTIVE MATERIAL" and the radiation symbol described in NAC 459.355, if practicable.

6. The device has been registered in the Sealed Source and Device Registry maintained by the Nuclear Regulatory Commission.

Bd. of Health, Radiation Control Reg. ยงยง 3.5.5.4-3.5.5.4.1.3.3.1, eff. 2-28-80-NAC A 1-18-94; R085-06, 11-13-2006; R185-08, 5-7-2010; A by R144-13A, eff. 10-13-2016

NRS 459.201

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