A-A-0051960 Intravenous Injection Set (Non-Vented, With Metering Chamber)This interim commercial item description covers an intravenous injection set which is non-vented and includes a metering chamber with automatic shut off.

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A-A-0051960(DM)

B. Inoculated product or simulated product. For each type of sterilization, the organism used shall be as listed below:

Type of Sterilization	Organism
Steam	B. stearothermophilus
Dry Heat	B. stearothermophilus B. subtilis
Ethylene oxide	B. subtilus
Gamma radiation	B. pumilus

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 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.

Contractor certification. The contractor shall certify that the product offered meets the salient characteristics of this description and conforms to the producers� own drawings, specifications, standards, and quality assurance practices. The Government reserves the right to require proof of such conformance prior to first delivery and thereafter as may be otherwise provided for under the provisions of the contract.