COMMERCIAL ITEM DESCRIPTION A-A-53010
C. 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 B. Inoculated product or simulated product. The method of sterilization will control the organism in the spore strip to be tested for as shown in B. NOTE: When an inoculated carrier is chosen, product samples must also be tested as required by the USP and paragraphs A and B.
D. Alternate method. Suppliers conducting sterility tests for designating lots in a manner other than that indicated herein shall submit proof that the alternate method provides equal assurance concerning the sterility of the product. However, all sterility tests shall be conducted using biological indicators. Requests for approval of any alternate method of testing for sterility shall be made to the contracting officer, and approval obtained before employment of the alternate method on a government contract.
E. Product testing. Testing for sterility of the product after receipt by the government shall be without a biological indicator and in accordance with the USP. The inspection level shall be as stated in paragraph A above.
Sampling for examination shall be conducted in accordance with MIL-STD-105. The inspection level and acceptable quality level shall be as shown in Table I.
Sampling for tests.
|
Characteristics |
Inspection level |
AQL (% defective) |
|
Pressure test |
S-1 |
* |
|
Sterility |
(See clauses shown above) |
|
|
USP Class IV |
S-1 |
* |
* Acceptance number shall be zero for all sample sizes.
Instructions. Detailed instructions shall be present in the container for each catheter and needle unit.
Workmanship. The catheter and needle unit shall be free from defects which detract from its appearance or impair its serviceability.
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