(a) Each person licensed under § 32.14 for products for which quality control procedures are required shall:
(1) Maintain quality assurance systems in the manufacture of the part or product, or the installation of the part into the product, in a manner sufficient to provide reasonable assurance that the safety-related components of the distributed products are capable of performing their intended functions;
(2) Subject inspection lots to acceptance sampling procedures, by procedures specified in the license issued under § 32.14, to provide at least 95 percent confidence that the Lot Tolerance Percent Defective of 5.0 percent will not be exceeded; and
(3) Visually inspect each unit in inspection lots. Any unit which has an observable physical defect that could adversely affect containment of the byproduct material must be considered a defective unit.
(b) No person licensed under § 32.14 shall transfer to other persons for use under § 30.15 of this chapter or equivalent regulations of an Agreement State:
(1) Any part or product tested and found defective under the criteria and procedures specified in the license issued under § 32.14, unless the defective part or product has been repaired or reworked, retested, and found by an independent inspector to meet the applicable acceptance criteria; or
(2) Any part or product contained within any lot that has been sampled and rejected as a result of the procedures in paragraph (a)(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 § 32.14; and
(ii) Each individual sub-lot is sampled, tested, and accepted in accordance with the procedures specified in paragraphs (a)(2) and (b)(2)(i) of this section and any other criteria that may be required as a condition of the license issued under § 32.14.
(c) [Reserved]
(d) Each person licensed under § 32.14 for products for which quality control procedures are required shall:
(1) Label or mark each unit, except timepieces or hands or dials containing tritium or promethium-147, and its container so that the manufacturer or initial transferor of the product and the byproduct material in the product can be identified.
(2) For ionization chamber smoke detectors, label or mark each detector and its point-of-sale package so that:
(i) Each detector has a durable, legible, readily visible label or marking on the external surface of the detector containing:
(A) The following statement: “CONTAINS RADIOACTIVE MATERIAL”;
(B) The name of the radionuclide (“americium-241” or “Am-241”) and the quantity of activity; and
(C) An identification of the person licensed under § 32.14 to transfer the detector for use under § 30.15(a)(7) of this chapter or equivalent regulations of an Agreement State.
(ii) The labeling or marking specified in paragraph (d)(2)(i) of this section is located where it will be readily visible when the detector is removed from its mounting.
(iii) The external surface of the point-of-sale package has a legible, readily visible label or marking containing:
(A) The name of the radionuclide and quantity of activity;
(B) An identification of the person licensed under § 32.14 to transfer the detector for use under § 30.15(a)(7) or equivalent regulations of an Agreement State; and
(C) The following or a substantially similar statement: “THIS DETECTOR CONTAINS RADIOACTIVE MATERIAL. THE PURCHASER IS EXEMPT FROM ANY REGULATORY REQUIREMENTS.”
(iv) Each detector and point-of-sale package is provided with such other information as may be required by the Commission.
[31 FR 5317, Apr. 2, 1966, as amended at 34 FR 6652, Apr. 18, 1969; 39 FR 22129, June 20, 1974; 43 FR 6922, Feb. 17, 1978; 72 FR 58487, Oct. 16, 2007; 73 FR 42673, July 23, 2008; 77 FR 43691, July 25, 2012; 86 FR 43402, Aug. 9, 2021]