A-A-51766 Catheter And Needle Unit, Intravenous, (18 Gage Catheter)This commercial item description covers a catheter placement unit.

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COMMERCIAL ITEM DESCRIPTION A-A-51766

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 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.

Hydraulic – 20 psig water pressure, 2 minutes

Pneumatic – 10 psig air pressure, 1 minute

Inspection levels and AQL’s shall be as shown in the following table:

* Each lot need not be tested if certification is provided to show identical materials and processing have been used on present contract as for material previously submitted, inspected and approved.