A-A-51630A
Sterility. The sterile components shall meet the sterility requirements when tested in accordance with the USP or AAMI guidelines. Sterility assurance level shall be 0.0001.
Pull test. The needle cannula shall not pull out of, or loosen from, the needle hub wshen subjected to an axial force of ten pounds for a period of 3 minutes. Both needles shall meet this test requirements.
Workmanship. The set components shall be free from defects which detract from their appearance or impair its serviceability. Plastic components shall be free from dents, kinks, pits, blisters, flash, cuts, holes and scratches. Metal components shall be free from dents, pits, burrs, slivers, scale and corrosion. Needles shall not be bent, shall be sharp and shall be free from feathered edges.
Unit. Package (PG). One package containing one hundred collecting sets, each set contained in a snap-open polybag 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.
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