---
kind: "section"
citation: "10 C.F.R. § 32.15"
title: "10"
number: "32.15"
heading: "Same: Quality assurance, prohibition of transfer, and labeling."
url: "https://uscodex.org/cfr/10/32.15"
---

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

- (a) Each person licensed under [§ 32.14](/cfr/10/32.14.md) 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](/cfr/10/32.14.md), 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](/cfr/10/32.14.md) shall transfer to other persons for use under [§ 30.15](/cfr/10/30.15.md) 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](/cfr/10/32.14.md), 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)](#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](/cfr/10/32.14.md); and
    - (ii) Each individual sub-lot is sampled, tested, and accepted in accordance with the procedures specified in paragraphs [(a)(2)](#a-2) and [(b)(2)(i)](#b-2-i) of this section and any other criteria that may be required as a condition of the license issued under [§ 32.14](/cfr/10/32.14.md).
- (c) [Reserved]
- (d) Each person licensed under [§ 32.14](/cfr/10/32.14.md) 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](/cfr/10/32.14.md) to transfer the detector for use under [§ 30.15(a)(7)](/cfr/10/30.15.md?p=a-7) of this chapter or equivalent regulations of an Agreement State.
    - (ii) The labeling or marking specified in [paragraph (d)(2)(i)](#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](/cfr/10/32.14.md) to transfer the detector for use under [§ 30.15(a)(7)](/cfr/10/30.15.md?p=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.

## Notes

### Amendments

[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]

### Authority

Authority: Atomic Energy Act of 1954, secs. 81, 161, 170H, 181, 182, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2210h, 2231, 2232, 2233, 2273, 2282, 2021); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note.

### Amendments

[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]