COMMERCIAL ITEM DESCRIPTION A-A-51273
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 of 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.
Workmanship. The catheter and needle unit shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing 50 individually packaged catheter and needle units, as specified, constitutes one unit. The individual package shall be a sealed, peel-open type container capable of maintaining sterility of contents unless the tray is damaged or opened.
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.
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 the Government’s 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 or procedures) and testing (determination by technical means of physical and chemical properties) of the item.
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