A-A-54528
The packs shall be sterile and individually wrapped in a suitable tear-resistant, waterproof, heat sealed package which shall allow aseptic handling and maintain sterility of the contents until opened or damaged. Items shall be packed in sequence of use.
Sterility of the packs shall be in accordance with the USP or AAMI requirements. Sterility assurance level shall be 0.000001.
All pack components shall be clearly listed on the exterior wrapper which shall also serve as a dust cover.
Workmanship. The surgical pack shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing four individual packaged sterile laparotomy packs, as specified, constitutes unit. The individual package shall be a suitable container capable of maintaining sterility of contents unless package damaged or opened. Items shall be packed in sequence of use.
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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