459.306 - Specific licenses: Manufacture and distribution of sources and devices for medical use

459.306. Specific licenses: Manufacture and distribution of sources and devices for medical use

An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to 10 C.F.R. Part 35 or equivalent regulations of an agreement state, for use as a calibration, transmission or reference source or for the uses listed in 10 C.F.R. §§ 35.400, 35.500, 35.600 and 35.1000 or equivalent regulations of an agreement state, will be approved if:

1. The applicant satisfies the general requirements in NAC 459.238;

2. The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including:

(a) The radioactive material contained, its chemical and physical form, and amount;

(b) Details of design and construction of the source or device;

(c) Procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and in accidents;

(d) For devices containing radioactive material, the radiation profile of a prototype device;

(e) Details of quality control procedures to ensure that production sources and devices meet the standards of the design and prototype tests;

(f) Procedures and standards for calibrating sources and devices;

(g) Legends and methods for labeling sources and devices as to their radioactive content; and

(h) Instructions for handling and storing the source or device from the radiation safety standpoint, which instructions must be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device, provided that instructions which are too lengthy for the label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

3. The label affixed to the source, device or permanent storage container for the source or device contains information on the radionuclide, quantity and date of assay, and a statement that the source or device is approved by the Division for distribution to persons licensed to use radioactive material identified in 10 C.F.R. §§ 35.65, 35.400, 35.500 and 35.600 or to persons who hold equivalent licenses of the Nuclear Regulatory Commission or an agreement state ; and

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

Bd. of Health, Radiation Control Reg. §§ 3.5.5.12-3.5.5.12.1.3, eff. 2-28-80-NAC A 9-6-88; 11-1-95; R085-06, 11-13-2006; R149-07, 1-30-2008; R185-08, 5-7-2010; A by R144-13A, eff. 10-13-2016

NRS 459.201

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