A-A-54154
Toxicity, pyrogenocity, sterility. The finished catheter and needle unit shall be nontoxic and nonpyrogenic in accordance with the USP for Transfusion and Infusion assemblies (the rabbit pyrogen test) or the Bacterial Endotoxins test (LAL) with the rabbit pyrogen test used for LAL test failure. The catheter and needle unit shall be sterile with a Sterility Assurance Level of 1 x 10-6 in accordance with AAMI guidelines.
Sterility lot and traceability. A sterility lot is that quantity of product sterilized in the same sterilizing chamber at the same time. Each quantity of product shall be traceable to a given manufacturing operation or lot. Each unit package shall be traceable to a given sterility or manufacturing lot (See Note 4).
Instructions. Each catheter and needle unit package shall contain instructions for use. These instructions shall include a caution note stating in effect “Do not attempt to retract catheter while needle is the vein”.
Workmanship. The catheter and needle unit shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Package (PG). One package containing 50 individually packaged catheter and needle units of the size only with “Instructions for Use” as specified, constitutes one unit. The individual package shall be a sealed, peel-open type container or other suitable sealed container capable of maintaining sterility of contents unless 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.
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