COMMERCIAL ITEM DESCRIPTION A-A-51463
Solution tray. The tray shall be a disposable, collapsible container. The tray shall be a disposable, collapsible container. The tray shall be capable of holding fluids for one hour without becoming saturated with liquid or leaking. The tray shall hold a minimum of 240 millimeters of solution.
Glove. The glove shall be pre-cuffed. The glove shall be size medium or large and shall meet the requirements of American Society for Testing and Materials (ASTM) Standard D3578.
Materials. The catheter tubing shall be manufactured from flexible polyvinyl chloride (PVC). The catheter tubing adapter shall be manufactured from a rigid plastic. The glove shall be manufactured from vinyl or latex.
Physical characteristics.PVC material shall be tested for tensile strength and ultimate elongation in accordance with ASTM Standard D638. The catheter tubing material shall have a minimum tensile strength of 1500 pounds per square inch (psi) and a minimum ultimate elongation of 200 percent. The tubing material shall be tested for hardness in accordance with ASTM D2240, and shall have a Shore Durometer hardness of A77-A80. A sufficient amount of material shall be tested as to be representative of the lot. Any test failure shall be cause for rejection.
Sterility. The components of the set shall be sterile when tested in accordance with the United States Pharmacopeia (USP).
Toxicity. PVC used in the catheter tubing shall meet the requirements of the USP for Class IV plastic.
Workmanship. The finished catheter shall be free from loose flash cracks, burrs, or sharp edges. There shall be no defects which affect the life, appearance, or serviceability.
Product Quality Level.
Visual and dimensional examination. Shall be examined to verify that 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. Package (PG). Each catheter set shall be individually packaged in a peel-open type container capable of maintaining sterility of contents unless package is damaged or opened. One packaged containing 100 catheter sets of one size only, as specified, constitutes unit.
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