Breaking strength. Catheters shall be tested for breaking strength and ultimate elongation before and after accelerated aging Paragraphs 1 thru 4 of Methods 4111 and 4121 of Federal Test Method Standard 601 shall be used for breaking strength and ultimate elongation, respectively. Two specimens shall be cut from each catheter sampled. One specimen shall be tested aged and the other specimen shall be tested unaged. Aging shall be performed using Method 7221 or 7231 of Federal Test Method Standard 601. The average of the breaking strengths recorded for each unaged specimen shall be at least 155 pounds. The breaking strength and ultimate elongation shall be at least 75 percent of the value obtained from the unaged specimen cut from the same catheter.
Workmanship. The catheter shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing twelve individually packaged sterile catheters, as specified constitutes one unit. The individual package shall be a sealed, peel-open type container capable of maintaining the sterility of the contents unless the package is damaged or opened.
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.
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