COMMERCIAL ITEM DESCRIPTION A-A-51886
The number of viable spores shall be sufficient to provide assurance that the product has been sterilized.
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 of 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 or designating lots in a manner other than 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 USP. The inspection level shall be as stated in paragraph A above.
Workmanship. The set shall be free from defects which detract from their appearance or impair its serviceability.
Unit. Package (PG). One package containing 50 intravenous injection sets, each set individually packaged, sterile or with sterile fluid path in a sealed peel-open container, constitutes one unit.
Quality Assurance Provisions.
Responsibility for inspection. Unless otherwise specified in the contract or purchase order, the contractor is responsible for the performance of all inspection requirements as specified herein. Except as otherwise specified in the contact or purchase order, the contractor may use his own or any facilities suitable for the performance of the inspection requirements specified herein, unless disapproved by the Government. The Government reserves the right to perform any of the inspections set forth in the specification where such inspections are deemed necessary to assure supplies and services conform to prescribed requirements.
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