A-A-54154
Catheter. The catheter shall be fabricated from clear polyvinylchloride (PVC), polytetrafluroethylene (PTFE) or polyurethane which meets the requirements of the United States Pharmacopeia (USP) for Class IV plastics (See Notes 2). The catheter hub shall be fabricated from rigid or semi-rigid plastic which meets the requirements of USP for class II plastics.
Needle and needle collar. The needle shall be fabricated from Class 3 austenitic stainless steel in accordance with ASTM Designation F899. The needle collar shall be fabricated from rigid plastic.
Wire stylet. The wire shall be fabricated from Class 3 austenitic stainless steel in accordance with ASTM Designation F899.
Protective sleeve. The protective sleeve shall be fabricated from transparent or translucent flexible polyethylene.
Needle cover, needle guard, and flow control plug. The needle cover, needle guard, and flow control plug shall be fabricated from rigid plastic.
Style and design. The catheter shall consist of a needle, the lumen through which an indwelling catheter shall pass. The needle shall have a lumen 2 + 1/8 inches long and be of short bevel design. The needle point tip shall be ground to maximum keenness and the needle point heel shall be dull to prevent coring. The needle hub shall make a secure fit when pushed through the needle collar, which is permanently secured to the protective sleeve. The unit shall be supplied with a needle guard for safety prior to use and a folding needle cover for covering the needle after being withdrawn, following venipuncture.
Following venipuncture and needle withdrawal, the needle cover shall enclose and lock the entire needle cannula, preventing the needle bevel from shearing the catheter.
The catheter shall be permanently secured to the Luer-lock catheter hub if of two-piece construction. If of one piece construction, the proximal end shall incorporate a Luer-lock hub. The distal edges of the catheter shall be free from burrs and cuts. the wire stylet shall move freely within the catheter and have a flow control plug permanently secured to its proximal end.
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