10 CFR 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.
- (d)(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.