Same: Quality assurance, prohibition of transfer.

CFR · 2024-01-01 · US · Title 10

(a) Each person licensed under § 32.53 shall visually inspect each device and shall reject any that has an observable physical defect that could adversely affect containment of the tritium or promethium-147. (b) Each person licensed under § 32.53 shall: (1) Maintain quality assurance systems in the manufacture of the luminous safety device in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed devices are capable of performing their intended functions; and (2) Subject inspection lots to acceptance sampling procedures, by procedures specified in paragraph (c) of this section and in the license issued under § 32.53, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded. (c) The licensee shall subject each inspection lot to: (1) Tests that adequately take into account the individual, aggregate, and cumulative effects of environmental conditions expected in service that could adversely affect the effective containment of tritium or promethium-147, such as absolute pressure and water immersion. (2) Inspection for evidence of physical damage, containment failure, or for loss of tritium or promethium-147 after each stage of testing, using methods of inspection adequate for applying the following criteria for defective: (i) A leak resulting in a loss of 0.1 percent or more of the original amount of tritium or promethium-147 from the device; (ii) Levels of radiation i

official document · source cfr-2024 · id 10:§ 32.55