An application for a specific license to manufacture, assemble, repair or initially transfer luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under § 31.7 of this chapter, will be approved if:
(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;
(b) The applicant submits sufficient information regarding each device pertinent to evaluation of the potential radiation exposure, including:
(1) Chemical and physical form and maximum quantity of tritium or promethium-147 in each device;
(2) Details of construction and design;
(3) Details of the method of binding or containing the tritium or promethium-147;
(4) Procedures for and results of prototype testing to demonstrate that the tritium or promethium-147 will not be released to the environment under the most severe conditions likely to be encountered in normal use;
(5) Quality assurance procedures to be followed that are sufficient to ensure compliance with § 32.55;
(6) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device.
(c) Each device will contain no more than 10 curies of tritium or 300 millicuries of promethium-147. The levels of radiation from each device containing promethium-147 will not exceed 0.5 millirad per hour at 10 centimeters from any surface when measured through 50 milligrams per square centimeter of absorber.
(d) The Commission determines that:
(1) The method of incorporation and binding of the tritium or promethium-147 in the device is such that the tritium or promethium-147 will not be released under the most severe conditions which are likely to be encountered in normal use and handling of the device;
(2) The tritium or promethium-147 is incorporated or enclosed so as to preclude direct physical contact by any person with it;
(3) The device is so designed that it cannot easily be disassembled; and
(4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (e) of this section.
(e) The applicant shall subject at least five prototypes of the device to tests as follows:
(1) The devices are subjected to 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 temperature, moisture, absolute pressure, water immersion, vibration, shock, and weathering.
(2) The devices are inspected for evidence of physical damage and for loss of tritium or promethium-147, after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (e)(3) of this section.
(3) Device designs are rejected for which the following has been detected for any unit:
(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; or
(ii) Surface contamination of tritium or promethium-147 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or
(iii) Any other evidence of physical damage.
(f) The device has been registered in the Sealed Source and Device Registry.
[30 FR 8192, June 26, 1965, as amended at 33 FR 6463, Apr. 27, 1968; 43 FR 6923, Feb. 17, 1978; 77 FR 43693, July 25, 2012]