10 CFR 32.61 - Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.
An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under § 31.10 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 type of device pertinent to evaluation of the potential radiation exposure, including:
(4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use;
(8) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the device;
(d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by § 20.1901(a) of this chapter, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;
(1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;
(2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use;
(4) Prototypes of the device have been subjected to and have satisfactorily passed the tests required by paragraph (f) of this section.
(5) Quality control procedures have been established to satisfy the requirements of § 32.62.
(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 strontium-90, 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 strontium-90 after each stage of testing, using methods of inspection adequate for determining compliance with the criteria in paragraph (f)(3) of this section.
(i) A leak resulting in a loss of 0.1 percent or more of the original amount of strontium-90 from the device; or
(ii) Surface contamination of strontium-90 on the device of more than 2,200 disintegrations per minute per 100 square centimeters of surface area; or
[30 FR 9905, Aug. 10, 1965, as amended at 43 FR 6923, Feb. 17, 1978; 56 FR 23472, May 21, 1991; 58 FR 67660, Dec. 22, 1993; 77 FR 43694, July 25, 2012]
Title 10 published on 2014-01-01
no entries appear in the Federal Register after this date.