A-A-53423
Sterility, pyrogenicity and toxicity. The internal surfaces of the bag, connected tubing, and fitting shall be sterile, non-pyrogenic and non-toxic when tested in accordance with the USP for transfusion and infusion assemblies.
Workmanship. The blood warming bag shall be free from defects which detract from its appearance or impair its serviceability. The blood warming bag shall be free from cuts, tears, holes, weak sections, inclusions, and bubbles. The blood warming bag shall be free from grease, dirt and foreign material.
Unit. Package (PG). One package containing twenty-four individually packaged blood warming bags, 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 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.
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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