A-A-0051837 Drape, Surgical

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A-A-0051837(DM)

The minimum number of test units, regardless of lot size, shall be 10 except for inoculated carrier which shall be 20. For Sterilization the organism used shall be as listed below:

Type of Sterilization	Organism	Incubation Temperature Degrees C
Steam	B. stearothermophilus	55-65
Dry Heat	B. stearothermophilus, or B. subtilis var. niger (or globigii)	55-65 30-35
Gas	B. subtilis var. niger (or globigii)	30-35
Radiation	B. pumilus	30-35

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

Inoculated carriers (paper short strips) if used shall be in accordance with MIL-S-36586. Other paper carriers shall be inoculated to be of equivalent resistance. The method, incubation and number of test units shall be as indicated herein for inoculated product or simulated product. The method of sterilization will control the organism in the spore strip to be tested for as shown above.

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

Alternate method. Suppliers conducting sterility tests in a manner other than that indicated herein shall submit proof that the alternate method provides equal assurance concerning the sterility of the product. 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.

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.

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.