A-A-53499
Sterility. The surgical packs shall be sterilized in accordance with the requirements of the food and drug administration (FDA).
Workmanship. The surgical pack shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing three or four individually sterile surgical packs, disposable as specified, constitutes one unit. Each surgical pack shall be individually wrapped in a suitable tear resistant heat sealed package. The individual package shall be capable of maintaining sterility of contents unless the package is damaged or opened. Each pack shall also be wrapped in a heat sealed exterior dust cover. All pack components shall be clearly listed on the exterior wrapper.
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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