10 CFR 32.55 - Same: Quality assurance, prohibition of transfer.

§ 32.55 Same: Quality assurance, prohibition of transfer.
(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 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
(iii) Any other criteria specified in the license issued under § 32.53.
(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:
(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
(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:
(i) A procedure for defining sub-lot size, independence, and additional testing procedures is contained in the license issued under § 32.53; and
(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.
[77 FR 43693, July 25, 2012]

Title 10 published on 2014-01-01

no entries appear in the Federal Register after this date.

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United States Code

Title 10 published on 2014-01-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 10 CFR 32 after this date.

  • 2014-09-22; vol. 79 # 183 - Monday, September 22, 2014
    1. 79 FR 56524 - Medical Use of Byproduct Material—Medical Event Definitions, Training and Experience, and Clarifying Amendments; Correction
      GPO FDSys XML | Text
      NUCLEAR REGULATORY COMMISSION
      Proposed rule; correction.
      This correction is effective on September 22, 2014. Submit comments on the information collection aspects of the proposed rule by October 22, 2014.
      10 CFR Parts 30, 32 and 35