Manufacture and distribution of sources or devices containing byproduct material for medical use.

CFR · 2024-01-01 · US · Title 10

(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed under part 35 of this chapter for use as a calibration, transmission, or reference source or for the uses listed in §§ 35.400, 35.500, 35.600, and 35.1000 of this chapter will be approved if: (1) The applicant satisfies the general requirements in § 30.33 of this chapter; (2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including: (i) The byproduct material contained, its chemical and physical form, and amount; (ii) Details of design and construction of the source or device; (iii) 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 accidents; (iv) For devices containing byproduct material, the radiation profile of a prototype device; (v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests; (vi) Procedures and standards for calibrating sources and devices; (vii) Legend and methods for labeling sources and devices as to their radioactive content; (viii) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or atta

official document · source cfr-2024 · id 10:§ 32.74