A-A-54232
Material. The catheter shall be fabricated of polyvinylchloride which meets the requirements of the USP for Class IV plastics. The stylet and suture tie sleeve shall be fabricated of Type 304 stainless steel in accordance with ASTM Designation F899. The inflatable balloon shall be fabricated from latex rubber.
Sterility, pyrogenocity and toxicity. The catheter shall be non-pyrogenic and nontoxic in accordance with the USP. The catheter shall be sterile in accordance with USP or AAMI guidelines at a Sterility Assurance Level of 0.000001.
Radiopacity. Except for the insertion depth markings and the latex balloon, the catheter shall radiopaque in accordance with commercial practice.
Saline resistance. The catheter and balloon shall be tested for intravenous fluid compatibility by submersion in 5% USP saline solution at 37 +/- °C for 72 hours. Afterward, the balloon shall be fully inflated and deflated once every 20 minutes for 8 hours.
Shelf life. The shelf life date shall be printed on the package label and at least 24 months shelf life shall remain at the time of delivery to the Government.
Markings. The catheter shall be marked with product model number and balloon inflation capacity. The catheter shall be legibly marked every 10 centimeters to indicate depth of penetration.
Workmanship. The catheter shall be free from defects which affect life, utility or appearance.
PRODUCT QUALITY LEVEL.
Visual and dimensional examination. Shall be examined to verify that the design, construction and workmanship are in accordance with applicable requirements.
Materials. The supplier shall be responsible for performing tests to assure that materials are in accordance with requirements specified.
Unit. Each (EA). Each catheter packaged in a rigid plastic tray or tube, as specified, constitutes one unit. The balloon shall be provided with a protector. The tray shall be packaged in a sealed, peel-open type container capable of maintaining sterility of the content unless the container is damaged or opened. The container shall be constructed of tyvek having clear plastic backing.
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