COMMERCIAL ITEM DESCRIPTION A-A-51410
A.3 Alternate method. Suppliers conducting sterility tests of designating lots in 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. Request 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.
A.4 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.3 above.
Workmanship. The suture shall be free from defects which detract from their appearance or impair their serviceability.
Unit. Package (PG). One package containing thirty-six individually packaged suture as specified, 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 otherwise specified in the contract or purchase order, the contractor may use his own or any facilities suitable for the performance for 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.
Records. Records of examinations and tests performed by or for the contractor shall be maintained by the contractor and made available to the Government upon request, at any time, or from time to time, during the performance of the contract and for a period of three years after delivery of the supplies to which such records relate.
Inspection. Inspection, as used herein, is defined as both examination (such as visual or auditory investigation without the use of special laboratory appliances and procedures) and testing (determination by technical means and chemical properties) of the item.
Tests. Tests shall be conducted to determine compliance with specification requirements. Where feasible, the same sample shall be used for the determination of two or more test characteristics.
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