A-A-51267A
Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics.
Sampling for tests. Sampling for tests shall be conducted in accordance with MIL-STD-105 and as specified herein. The unit of product for test purposes shall be one (1) pack. Unless otherwise specified, sampling for examination shall be conducted at Inspection Level II, AQL 2.5, and sampling for tests shall be conducted at Inspection Level S-1, acceptance number is zero.
Sterility test. The surgical pack shall be tested for sterility in accordance with the method specified in the U.S. Pharmacopeial Convention Publication: Pharmacopoeia of the United States, Mack Publishing Co., Easton, PA 18042 (USP), for purified cotton, gauze, surgical dressings and related material using inoculated product, inoculated simulated product, or paper spore strip (carrier). The incubation temperature shall be as listed below. Product containing a biological indicator shall be marked or labeled, so that it clearly differentiates from product intended for product intended for distribution. The incubation medium and minimum time in each case shall be soybean casein digest for 7 days for inoculated product. The minimum number of test units, regardless of lot size, shall be 10, except for inoculated carrier which shall be 20. For sterilization, the organism used shall be as listed below:
|
Type of Sterilization |
Organism |
Incubation Temperature Degrees C |
|
Steam |
B.stearothermophilus |
55-65 |
|
Dry Heat |
B.stearothermophilus B.subtilis var. niger (or globigil) |
55-65 |
|
Gas |
B.subtilis var. niger (or globigil) |
30-35 |
|
Radiation |
B. pumilus |
30-35 |
The number of viable cells shall be sufficient to provide assurance that the product has been sterilized.
Inoculated carriers (paper spore strips) if used shall be in accordance with MIL-S-36586. Other paper carriers shall be inoculated to be of equivalent resistance. The method, incubation and number of test units shall be as indicated herein for inoculated product or simulated product. The method of sterilization will control the organism in the spore strip to be tested for as shown above.
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