Editorial Note on Part 32
Editorial Note: Nomenclature changes to part 32 appear at 79 FR 75739, Dec. 19, 2014.

§ 32.15 Same: Quality assurance, prohibition of transfer, and labeling. ( 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]