Each person licensed under § 32.57 shall perform a dry wipe test upon each source containing more than 0.1 microcurie of americium 241 prior to transferring the source to a general licensee under § 31.8 of this chapter. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the paper shall be measured by using radiation detection instrumentation capable of detecting 0.005 microcurie of americium 241. If any such test discloses more than 0.005 microcurie of radioactive material, the source shall be deemed to be leaking or losing americium 241 and shall not be transferred to a general licensee under § 31.8 of this chapter.

§ 32.60 Same: material transfer reports.

Each person licensed under § 32.57 shall file an annual report with the Director, Division of Materials Licensing, U.S. Atomic Energy Commission, Washington, D.C., 20545, which shall state the total quantity of americium 241 transferred to persons generally licensed under § 31.8 of this chapter. The report shall identify each general licensee by name and address, state the kinds and numbers of sources transferred, and specify the quantity (in microcuries) of americium 241 in each kind of source. Each report shall cover the calendar year and shall be filed within thirty (30) days after the end of each calendar year. § 32.61 Ice detection devices containing strontium 90: requirements for license to manufacture or import. An application for a specific license to manufacture or import ice detection devices containing strontium 90 for distribution to persons generally licensed

(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:

(1) Chemical and physical form and maximum quantity of strontium 90 in the device;

(2) Details of construction and design of the source of radiation and its shielding;

(3) Radiation profile of a prototype device;

(4) Precedures 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;

(5) Details of quality control procedures to be followed in manufacture of the device;

(6) Description of labeling to be affixed to the device;

(7) Instructions for handling and installation of the device;

(8) 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 50 microcuries of strontium 90 in an insoluble form.

(d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by § 20.203 (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.

(e) The Commission determines that: (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 conduct 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;

(3) The device is so designed that it cannot be easily disassembled;

(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.103; and

(5) Quality control procedures have been established to satisfy the requirements of § 32.62.

[30 F.R. 9905, Aug. 10, 1965]

§ 32.62 Same; quality control procedures.

Ice detection devices containing strontium 90 which are manufactured or imported under a license pursuant to § 32.61 shall be subjected to the following quality control procedures:

(a) Each person licensed under § 32.61 shall visually inspect each device and shall reject any which has an observable physical defect that could effect containment of the strontium 90.

(b) Each person licensed under § 32.61 shall test each device for possible loss of strontium 90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

(c) Each person licensed under § 32.61 shall subject a number of devices from each production lot, sampled in accordance with the procedures in § 32.110, to the following quality control procedures, and shall accept or reject production lots in accordance with the directions of § 32.110.

(1) Each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of physical contact between the water and the strontium 90. 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 atmos

pheric pressure. Any device which leaks, as evidenced by physical contact between the water and the strontium 90, shall be rejected.

(2) The immersion test water from the preceding test (1) of this paragraph shall be measured for radioactive material. If the amount of radioactive material in the immersion test water is greater than 0.1 percent of the original amount of strontium 90 in any device, the device shall be rejected.

(d) An application for a license or for amendment of a license may include a description of quality control procedures proposed as alternatives to those prescribed by paragraph (c) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed alternative procedures if the applicant demonstrates that they will assure the rejection of any device which has a leakage rate exceeding 0.1 percent of the original quantity of strontium 90 in any 24-hour period.

(e) No person licensed under § 32.61 shall transfer to persons generally licensed under § 31.10 of this chapter any device which has been tested and rejected under the criteria and procedures specified in this § 32.62.

[30 F.R. 9905, Aug. 10, 1965] § 32.63

Same; material transfer reports.

Each person licensed under § 32.61 shall file an annual report with the Director, Division of Materials Licensing, U.S. Atomic Energy Commission, Washington, D.C., 20545, which shall state the total quantity of strontium 90 transferred to persons generally licensed under § 31.10 of this chapter. The report shall identify each general licensee by name and address, state the kinds and numbers of devices transferred, and specify the quantity (in microcuries) of strontium 90 in each kind of device. Each report shall cover the calendar year and shall be filed within thirty (30) days after the end of each calendar year. [30 F.R. 9905, Aug. 10, 1965]

§ 32.70 Manufacture and distribution of byproduct materials for medical use under general license.

An application for a specific license to distribute byproduct material for use by physicians under the general license of § 35.31 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 evidence that the byproduct material is to be manufactured, labeled, and packaged in accordance with a new drug application which the Commissioner of Food and Drugs, Food and Drug Administration. has approved, or in accordance with a license for a biologic product issued by the Secretary, Department of Health, Education, and Welfare;

(c) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package:

This radioactive drug may be received, possessed and used only by physicians licensed to dispense drugs in the practice of medicine. Its receipt, possession, use and transfer are subject to the regulations and a general license of the United States Atomic Energy Commission or of a State with which the Commission has entered into an agreement for the exercise of regulatory authority.

(Name of manufacturer) § 32.101 Schedule B-Prototype tests for luminous safety devices for use in aircraft.

An applicant for a license pursuant to § 32.53 shall conduct prototype tests on each of five prototype luminous safety devices for use in aircraft as follows:

(a) Temperature-altitude test. The device shall be placed in a test chamber as it would be used in service. A temperature-altitude condition schedule shall be followed as outlined in the following steps:

Step 1. The internal temperature of the test chamber shall be reduced to -62° C. (-80° F.) and the device shall be maintained for at least 1 hour at this temperature at atmospheric pressure.

Step 2. The internal temperature of the test chamber shall be raised to 54° C.

(-65°F.) and maintained until the temperature of the device has stabilized at -54° C. at atmospheric pressure.

Step 3. The atmospheric pressure of the chamber shall be reduced to 83 millimeters of mercury absolute pressure while the chamber temperature is maintained at -54° C. Step 4. The internal temperature of the chamber shall be raised to -10° C. (+14°F.) and maintained until the temperature of the device has stabilized at -10° C., and the internal pressure of the chamber shall then be adjusted to atmospheric pressure. The test chamber door shall then be opened in order that frost will form on the device, and shall remain open until the frost has melted but not long enough to allow the

moisture to evaporate. The door shall then be closed.

Step 5. The internal temperature of the chamber shall be raised to +85° C. (185° F.) at atmospheric pressure. The temperature of the device shall be stabilized at +85° C. and maintained for 2 hours. The device shall then be visually inspected to determine the extent of any deterioration.

Step 6. The chamber temperature shall be reduced to +71° C. (160° F.) at atmospheric pressure. The temperature of the device shall be stabilized at+71° C. for a period of 30 minutes.

Step 7. The chamber temperature shall be reduced to +55° C. (130° F.) at atmospheric pressure. The temperature of the device shall be stabilized at this temperature for a period of 4 hours.

Step 8. The internal temperature of the chamber shall be reduced to +30° C. (86° F.) and the pressure to 138 millimeters of merThe cury absolute pressure and stabilized. device shall be maintained under these conditions for a period of 4 hours.

Step 9. The temperature of the test chamber shall be raised to +35° C. (95° F.) and the pressure reduced to 83 millimeters of mercury absolute pressure and stabilized. The device shall be maintained under these conditions for a period of 30 minutes.

Step 10. The internal pressure of the chamber shall be maintained at 83 millimeters of mercury absolute pressure and the temperature reduced to +20° C. (68° F.) and stabilized. The device shall be maintained under these conditions for a period of 4 hours.

(b) Vibration tests. This procedure applies to items of equipment (including vibration isolating assemblies) intended to be mounted directly on the structure of aircraft powered by reciprocating, turbojet, or turbo-propeller engines or to be mounted directly on gas-turbine engines. The device shall be mounted on an apparatus dynamically similar to the most severe conditions likely to be encountered in normal use. At the end of the test period, the device shall be inspected thoroughly for possible damage. Vibration tests shall be conducted under both resonant and cycling conditions according to the following Vibration Test Schedule (Table I):

VIBRATION TEST SCHEDULE
TABLE I

[Times shown refer to one axis of vibration]

When resonant frequencies are not apparent within the specified frequency range, the specimen shall be vibrated for periods twice as long as those shown for resonance in Table I at a frequency of 55 cycles per second and an applied double amplitude of 0.060 inch.

(3) Cycling. Devices to be mounted only on vibration isolators shall be tested by applying vibration along each of three mutually perpendicular axes of the device with an applied double amplitude of 0.060 inch and the frequency cycling between 10 and 55 cycles per second in 1-minute cycles for the periods and temperature conditions shown in Table I. Devices to be installed in aircraft without vibration isolators shall be tested by applying vibration along each of three mutually perpendicular axes of the device with an applied double amplitude of 0.036 inch or an applied acceleration of 10G, whichever is the limiting value, and the frequency cycling between 10 and 500 cycles per second in 15-minute cycles for the periods and temperature conditions shown in Table I.

(c) Accelerated weathering tests. The device shall be subjected to 100 hours of accelerated weathering in a suitable weathering machine. Panels of Corex D glass shall surround the arc to cut off the ultraviolet radiation below a wavelength of 2,700 angstroms. The light of the carbon arcs shall fall directly on the face of the device. The temperature at the sample shall be maintained at 50° C. plus or minus 3° C. Temperature measurements shall be made with a black panel thermometer.

(d) Shock test. The device shall be dropped upon a concrete or iron surface in a 3-foot free gravitational fall, or shall be subjected to equivalent treatment in a test device simulating such a free fall. The drop test shall be repeated 100 times from random orientations.

(e) Hermetic seal and waterproof test. On completion of all other tests prescribed by this section, the 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 evidence of bubbles emanating from within the

device, or water entering the device, shall be considered leakage.

(f) Observations. After each of the tests prescribed by this section, each device shall be examined for evidence of physical damage and for loss of tritium or promethium 147. Any evidence of damage to or failure of any device which could affect containment of the tritium or promethium 147 shall be cause for rejection of the design if the damage or failure is attributable to a design defect. Loss of tritium or promethium 147 from each tested device shall be measured by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The amount of tritium or promethium 147 in the water used in the hermetic seal and waterproof test prescribed by test paragraph (e) of this section shall also be measured. Measurements shall be made in an apparatus calibrated to measure tritium or promethium 147, as appropriate. The detection on the filter paper of more than 2,200 disintegrations per minute of tritium or promethium 147 per 100 square centimeters of surface wiped or in the water of more than 0.1 percent of the original amount of tritium or promethium 147 in any device shall be cause for rejection of the tested device. § 32.102 Schedule C-Prototype tests for calibration or reference sources containing americium 241.

An applicant for a license pursuant to § 32.57 shall, for any type of source which is designed to contain more than 0.005 microcurie of americium 241, conduct prototype tests, in the order listed, on each of five prototypes of such source, which contains more than 0.005 microcurie of americium 241, as follows:

(a) Initial measurement. The quantity of radioactive material deposited on the source shall be measured by direct counting of the source.

(b) Dry wipe test. The entire radioactive surface of the source shall be wiped with filter paper with the application of moderate finger pressure. Removal of radioactive material from the source shall be determined by measuring the radioactivity on the filter paper or by direct measurement of the radioactivity on the source following the dry wipe.

(c) Wet wipe test. The entire radioactive surface of the source shall be