Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer.

CFR · 2024-01-01 · US · Title 10

(a) An application for a specific license to manufacture, process, or produce self-luminous products containing tritium, krypton-85, or promethium-147, or to initially transfer such products for use pursuant to § 30.19 of this chapter or equivalent regulations of an Agreement State, will be approved if: (1) The applicant satisfies the general requirements specified in § 30.33 of this chapter: (2) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the self-luminous product to demonstrate that the product will meet the safety criteria set forth in § 32.23. The information should include: (i) A description of the product and its intended use or uses. (ii) The type and quantity of byproduct material in each unit. (iii) Chemical and physical form of the byproduct material in the product and changes in chemical and physical form that may occur during the useful life of the product. (iv) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (a)(2) (iii) and (xii) of this section. (v) Details of construction and design of the product as related to containment and shielding of the byproduct material and other safety features under normal and severe conditions of handling, storage, use, and disposal of the product. (vi) Maximum external radiation levels at 5 and 25 centimeters from any

official document · source cfr-2024 · id 10:§ 32.22