Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer.

CFR · 2024-01-01 · US · Title 10

An application for a specific license to manufacture, process, or produce gas and aerosol detectors containing byproduct material and designed to protect health, safety, or property, or to initially transfer such products for use under § 30.20 of this chapter or equivalent regulations of an Agreement State, will be approved if: (a) The applicant satisfies the general requirements specified in § 30.33 of this chapter: (b) The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, (1) A description of the product and its intended use or uses; (2) The type and quantity of byproduct material in each unit; (3) 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; (4) Solubility in water and body fluids of the forms of the byproduct material identified in paragraphs (b) (3) and (12) of this section; (5) 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; (6) Maximum external radiation levels at 5 and 25 centimeters from any external surface of the product, averaged over an area not to exceed 10 square centimeters, and the method of measurement; (7) Degree of access of human being

official document · source cfr-2024 · id 10:§ 32.26