---
kind: "section"
citation: "10 C.F.R. § 32.55"
title: "10"
number: "32.55"
heading: "Same: Quality assurance, prohibition of transfer."
url: "https://uscodex.org/cfr/10/32.55"
---

# §32.55. Same: Quality assurance, prohibition of transfer.

- (a) Each person licensed under [§ 32.53](/cfr/10/32.53.md) 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](/cfr/10/32.53.md) 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)](#c) of this section and in the license issued under [§ 32.53](/cfr/10/32.53.md), 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](/cfr/10/32.53.md).
- (d) No person licensed under [§ 32.53](/cfr/10/32.53.md) shall transfer to persons generally licensed under [§ 31.7](/cfr/10/31.7.md) 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](/cfr/10/32.53.md), or [paragraph (b)](#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)](#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](/cfr/10/32.53.md); and
    - (ii) Each individual sub-lot is sampled, tested, and accepted in accordance with paragraphs [(b)(2)](#b-2) and [(d)(2)(i)](#d-2-i) of this section and any other criteria that may be required as a condition of the license issued under [§ 32.53](/cfr/10/32.53.md).

## Notes

### Amendments

[77 FR 43693, July 25, 2012]

### 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

[77 FR 43693, July 25, 2012]