{"data":{"id":"us/10-cfr-32.55","jurisdiction":"us","citation":"10 CFR 32.55","heading":"Same: Quality assurance, prohibition of transfer.","body":"(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.\n(b) Each person licensed under § 32.53 shall:\n(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\n(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.\n(c) The licensee shall subject each inspection lot to:\n(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.\n(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:\n(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;\n(ii) Levels of radiation in excess of 5 microgray (0.5 millirad) per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, if the device contains promethium-147; and\n(iii) Any other criteria specified in the license issued under § 32.53.\n(d) No person licensed under § 32.53 shall transfer to persons generally licensed under § 31.7 of this chapter, or under an equivalent general license of an Agreement State:\n(1) Any luminous safety device tested and found defective under any condition of a license issued under § 32.53, or paragraph (b) of this section, unless the defective luminous safety device has been repaired or reworked, retested, and determined by an independent inspector to meet the applicable acceptance criteria; or\n(2) Any luminous safety device contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (b)(2) of this section, unless:\n(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.53; and\n(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs (b)(2) and (d)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under § 32.53.","path":["Title 10—Energy","CHAPTER I—NUCLEAR REGULATORY COMMISSION","PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL","Subpart B—Generally Licensed Items"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-10.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:09Z","sha256":"2dfaac59d5c530c6ec9db3287026841823ebbe4afce4fc842a863d2d38d967ce","source_id":"us-cfr","stale":true,"prev":"us/10-cfr-32.54","next":"us/10-cfr-32.56"},"notice":"GroundRules: Original legal text. Not legal advice."}