Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer.

CFR · 2024-01-01 · US · Title 10

An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241 or radium-226, for distribution to persons generally licensed under § 31.8 of this chapter, will be approved if: (a) The applicant satisfies the general requirements of § 30.33 of this chapter; (b) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including: (1) Chemical and physical form and maximum quantity of americium 241 or radium-226 in the source; (2) Details of construction and design; (3) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source; (4) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use; (5) Details of quality control procedures to be followed in manufacture of the source; (6) Description of labeling to be affixed to the source or the storage container for the source; (7) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source. (c) Each source will contain no more than 5 microcuries of americium-241 or radium-226. (d) The C

official document · source cfr-2024 · id 10:§ 32.57