A-A-54241
The graduate shall be fully graduated in at least 25 cc increments. The individual package shall be a sealed peel-open type container capable of maintaining sterility of contents unless the package is damaged or opened.
Sterility. The components and internal surfaces of the kit shall be sterile in accordance with USP or AAMI guidelines. Sterility assurance level shall be 0.000001.
Workmanship. The irrigation kits shall be free from defects which detract from their appearance or impair their serviceability. Kits shall be free from sharp edges, burrs, flash, distortions, and foreign material.
Unit. Package (PG). One package containing twenty (20) individually packaged sterile irrigation kits, 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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