A-A-51410 Suture, Nonabsorbable, Surgical Polypropylene, Monofilament, Single Armed

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COMMERCIAL ITEM DESCRIPTION A-A-51410

A. Sterility Test. The polypropylene suture shall be tested for sterility in accordance with the method in the USP using inoculated product, inoculated simulated product, or paper spore strip (carrier). Product containing a biological indicator shall be marked or labeled so that it clearly differentiates it from the product intended for distribution. The incubation medium for the paper spore strip (carrier) shall be soybean-casein digest. The incubation media for the inoculated product, or inoculated simulated product shall be fluid thioglycollate or alternative thioglycollate at 30^o or 25^oC for one half of specimens and soybean-casein digest at 20^oC for the remaining half of the specimen. The minimum incubation time shall be ten days. Sampling shall be as follows:

*Use a minimum of 20 specimens. Acceptance number is zero.

A.1 Inoculated product or simulate product. For each type of sterilization, the organism used shall be as listed below:

The number of variable spores shall be sufficient to provide assurance that the product has been sterilized.

A.2 Inoculated carrier. Inoculated carriers (paper spore strips) if used, shall be in accordance with MIL-S-36586A. Sterilization Test Strip Set, Bacterial Spore. Other paper carriers shall be inoculated to be equivalent resistance. The method of incubation and number of test units shall be as indicated in A. Sterility test and A.1 Inoculated product or simulated product. The method of sterilization will control the organism in the spore strip to be tested for as shown in A.1.

NOTE: When an inoculated carrier is chosen, product samples must also be tested as required by the USP and paragraphs A and A.1.