A-A-50997
4 September 1985
COMMERCIAL ITEM DESCRIPTION
CATHETER AND NEEDLE UNIT, INTRAVENOUS, Sterile
The General Services Administration has authorized the use of this commercial item description.
This commercial item description covers sterile, non-toxic, disposable, radiopaque, pyrogen-free, intravenous catheter placement units, suitable for extended intravenous therapy for a single venipuncture.
Salient characteristics:
Materials. The indwelling catheter shall be fabricated from clear or translucent, pliant plastic suitable in all respects for the purpose intended. The catheter shall be radiopaque throughout its length. The catheter, and all plastic components coming in contact with intravenous medication and patient’s blood shall contain no more than 5 parts per million of lead. The finished catheter shall be sterile, pryogen-free, and meet the requirements of the USP for class IV plastics. The needle cannula shall be fabricated austenitic corrosion-resistant steel. The needle hub shall be fabricated from a suitable corrosion-resistant alloy or from a suitable plastic meeting the requirements of the USP for class II plastics. The catheter Luer hub and flow control plug shall be fabricated from suitable plastics.
Construction. The unit shall permit aseptic insertion by a surgeon without assistance and without the necessity of hand scrubbing or wearing of sterile gloves. The unit shall consist of an outer metal needle securely fastened to a needle hub. The needle cannula length shall be 2 ± 1/8 inches. Each unit shall be provided with components necessary to protect needle before use and the catheter from the needle after venipuncture. The needle hub shall possess a groove or other feature that shall provide for good gripping technique during catheter insertion.
The radiopaque catheter proper shall make a free, sliding fit within the needle. Proximal end of plastic catheter shall have a plastic Luer lock hub permanently attached to the catheter. A thin gauge plastic sleeve, sealed at its proximal end, shall enclose the catheter assembly up to the needle hub. Sleeve sha;; be securely fixed to the plastic needle collar at the distal end. Plastic needle collar shall have a stiffening flange and an opening to form a firm but not removable fit on the outside diameter of the needle hub. The unit shall be provided with a flow control plug. The plug shall appropriately seat into the catheter Luer hub. The catheter hub shall pass gauging tests with the devices listed in ANSI/HIMA Standard MD70.1
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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