(v) Details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests; (vi) Procedures and standards for calibrating sources and devices;

(vii) Legend and methods for labeling sources and devices as to their radioactive content;

(viii) Instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device: Provided, That instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label;

(3) The label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the (name of source or device) is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to §§ 35.14 and 35.100 Group VI of 10 CFR Part 35 or under equivalent licenses of Agreement States or that a pending application for such license has been filed with the Atomic Energy Commission on or before October 15, 1974: Provided, That such labeling for sources which do not require long term storage (e.g., gold 198 seeds) may be on a leaflet or brochure which accompanies the sources.

(b)(1) In the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he shall include in his application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source.

(2) In determining the acceptable interval for test of leakage of radioactive material, the Commission will consider

information that includes, but is not limited to:

(i) Primary containment (source capsule);

(ii) Protection of primary containment;

(iii) Method of sealing containment; (iv) Containment construction materials;

(v) Form of contained radioactive material;

(vi) Maximum temperature withstood during prototype tests;

(vii) Maximum pressure withstood during prototype tests;

(viii) Maximum quantity of contained radioactive material;

(ix) Radiotoxicity of contained radioactive material;

(x) Operating experience with identical sources or devices or similarly designed and constructed sources or devices.

(c) If an application is filed pursuant to paragraph (a) of this section on or before October 15, 1974, for a license to manufacture and distribute a source or device that was distributed commercially on or before August 16, 1974, the applicant may continue the distribution of such source or device to group licensees until the Commission issues the license or notifies the applicant otherwise.

[39 FR 26149, July 17, 1974]

§ 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 tempera

ture 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 mercury absolute pressure and stabilized. The 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

(1) Determination of resonance frequency. Individual resonance frequency surveys shall be conducted by applying vibration to each device along each of any set of three mutually perpendicular axes and varying the frequency of applied vibration slowly through a range of frequencies from 5 cycles per second to 500 cycles per second with the double amplitude of the vibration not exceeding that shown in Figure 1 for the related frequency.

(2) Resonance tests. The device shall be vibrated at the determined resonance frequency for each axis of vibration for the periods and temperature conditions shown in Table I and with the applied double amplitude specified in Figure 1 for that resonance frequency. When more than one resonant frequency is encountered with vibration applied along any one axis, the test period may be accomplished at the most severe resonance or the period may be divided among the resonant frequencies, whichever is considered most likely to produce failure. 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

(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 wave-length 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

§ 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 americium241, conduct prototype tests, in the order listed, on each of five prototypes of such source, which contains more than 0.005 microcurie of americium241, 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 wiped with filter paper, moistened with water, 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 after it has dried or by direct measurement of the radioactivity on the source following the wet wipe.

(d) Water soak test. The source shall be immersed in water at room temperature for a period of 24 consecutive hours. The source shall then be removed from the water. Removal of radioactive material from the source shall be determined by direct measurement of the radioactivity on the

source after it has dried or by measuring the radioactivity in the residue obtained by evaporation of the water in which the source was immersed.

(e) Dry wipe test. On completion of the preceding test in this section, the dry wipe test described in paragraph (b) of this section shall be repeated.

(f) Observations. Removal of more than 0.005 microcurie of radioactivity in any test prescribed by this section shall be cause for rejection of the source design. Results of prototype tests submitted to the Commission shall be given in terms of radioactivity in microcuries and percent of removal from the total amount of radioactive material deposited on the source.

[30 FR 8192, June 26, 1965, as amended at 31 FR 15145, Dec. 2, 1966]

§ 32.103 Schedule D-Prototype tests for ice detection devices containing strontium-90.

An applicant for a license pursuant to § 32.61 shall conduct prototype tests on each of five prototype ice detection devices 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 Step 1 through Step 10 of § 32.101(a).

(b) Vibration tests. The device shall be subjected to vibration tests as set forth in § 32.101(b).

(c) Shock test. The device shall be subjected to shock test as set forth in § 32.101(d).

(d) 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 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 atmospheric pressure. Any visible evidence of physical contact between the water and the strontium-90 shall be considered leakage.

(e) Observations. After each of the tests prescribed by this section, each device shall be examined for evidence of physical damage and for loss of strontium-90. Any evidence of leakage or damage to or failure of any device which could affect containment of the strontium-90 shall be cause for rejection of the design if the damage or failure is attributable to a design defect. Loss of strontium-90 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 strontium-90 in the water used in the hermetic seal and waterproof test prescribed in paragraph (d) of this section shall also be measured. The detection on the filter paper of more than 2,200 disintegrations per minute of strontium-90 per 100 square centimeters of surface wiped or in the water of more than 0.1 percent of the original amount of strontium-90 in any device, shall be cause for rejection of the tested device.

[30 FR 9906, Aug. 10, 1965]

Subpart C-Quality Control Sampling

Procedures

§ 32.110 Acceptance sampling procedures under certain specific licenses.

(a) A random sample shall be taken from each inspection lot of devices licensed under §§ 32.14, 32.53, or 32.61 of this part for which testing is required pursuant to §§ 32.15, 32.55, or 32.62 in accordance with the appropriate Sampling Table in this section determined by the designated Lot Tolerance Percent Defective. If the number of defectives in the sample does not exceed the acceptance number in the appropriate Sampling Table in this section, the lot shall be accepted. If the number of defectives in the sample exceeds the acceptance number in the appropriate Sampling Table in this section, the entire inspection lot shall be rejected.

(b) Single sampling tables for Lot Tolerance Percent Defective: