A-A-51513B
Sizes. Catheters shall be provided in the following sizes, as specified:
6, 8, 10, 14, 18 French
The minimum length of 6 and 8 French catheters, exclusive of the connector, shall be 15.5 inches. The minimum length of 10, 14, and 18 French catheters, exclusive of the connector, shall be 18.5 inches. The style and design of the catheter ad connector shall be as in Figure 1.
The catheter and connector shall meet the requirements of the USP for Sterility, pyrogenocity, and safety.
Workmanship. The finished catheter and connector shall be free from loose flash, cracks, burrs, or sharp edges.
Unit. Package (PG). One package containing 50 individually packaged catheters constitutes one unit. Each catheter shall be packaged catheters constitutes one unit. Each catheter shall be packaged straight (not coiled) in a sealed peel-open type container capable of maintaining sterility of contents unless the container 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.
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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