32.55—Same: Quality assurance; prohibition of transfer.
(a)
Each person licensed under § 32.53 shall visually inspect each device and shall reject any which has an observable physical defect that could affect containment of the tritium or promethium-147.
(b)
Each person licensed under § 32.53 shall take a random sample of the size required by the table in § 32.110 for Lot Tolerance Percent Defective of 5.0 percent from each inspection lot, and shall subject each unit in the sample to the following tests:
(1)
Each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of water entry. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks as evidenced by bubbles emanating from within the device, or water entering the device, shall be considered as a defective unit.
(2)
The immersion test water from the preceding test in paragraph (b)(1) of this section shall be measured for tritium or promethium-147 content by an apparatus that has been calibrated to measure tritium or promethium-147, as appropriate. If more than 0.1 percent of the original amount of tritium or promethium-147 in any device is found to have leaked into the immersion test water, the leaking device shall be considered as a defective unit.
(3)
The levels of radiation from each device containing promethium-147 shall be measured. Any device which has a radiation level in excess of 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber, shall be considered as a defective unit.
(c)
An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (b) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that:
(1)
They will consider defective any sampled device which has a leakage rate exceeding 0.1 percent of the original quantity of tritium or promethium 147 in any 24-hour period; and
(2)
The operating characteristic curve or confidence interval estimate for the alternative procedures provides a Lot Tolerance Percent Defective of 5.0 percent at the consumer's risk of 0.10.
(d)
No person licensed under § 32.53 shall transfer to persons generally licensed under § 31.7 of this chapter :
(1)
Any luminous safety device which has been tested and found defective under the criteria and procedures specified in this section, unless the defective units have been repaired or reworked and have then met the tests set out in paragraph (b) of this section; or
(2)
Any inspection lot which has been rejected as a result of the procedures in § 32.110 or alternative procedures in paragraph (c) of this section, unless the defective units have been sorted and removed or have been repaired or reworked and have then met the tests set out in paragraph (b) of this section.