Byproduct material contained in devices for use under § 31.5; requirements for license to manufacture, or initially transfer.

CFR · 2024-01-01 · US · Title 10

(a) An application for a specific license to manufacture, or initially transfer devices containing byproduct material to persons generally licensed under § 31.5 of this chapter or equivalent regulations of an Agreement State will be approved if: (1) The applicant satisfies the general requirements of § 30.33 of this chapter; (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: (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 byproduct 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 1 year a dose in excess of 10 percent of the annual limits specified in § 20.1201(a) of this chapter; 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 dose to the appropriate organ as specified in Column IV of the table in § 32.24. (3) Each device bears a durable, legible, clearly visible label or labels approved by the Commission which contain in a clearly ident

official document · source cfr-2024 · id 10:§ 32.51