Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer.
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 Commission determines, with respect to any type of source containing more than 0.005 microcurie of americium-241 or radium-226, that:
(1) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 or radium-226 will not be released or be removed from the source under normal conditions of use and handling of the source; and
(2) The source has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.102, Schedule C, of this part.
[30 FR 8192, June 26, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 72 FR 55928, Oct. 1, 2007; 73 FR 42674, July 23, 2008]
Title 10 published on 2013-01-01
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