A-A-51303
19 December 1985
COMMERCIAL ITEM DESCRIPTION
CATHETER AND NEEDLE UNIT, INTRAVENOUS,
16 Gage Catheter, 8 Inches Long, 50s
The General Service Administration has authorized the use of this commercial item description.
This commercial item description covers a sterile, pyrogen-free, radiopaque, disposable, catheter and needle unit suitable for long term intravenous therapy.
Salient characteristics:
Materials. The indwelling catheter shall be fabricated from pliant fluorinated ethylene propylene (FEP), of the best quality and suitable in all respects for the purpose intended. 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, radiopaque pyrogen-free, non-toxic and meet the requirements of the USP for class IV plastics. The catheter shall meet the sterility requirements when tested in accordance with the USP.
The needle cannula shall be fabricated from class () type 304 austenitic corrosion-resistant steel of the composition listed in accordance with ASTM F899.
The catheter Luer hub and flow control plug shall be fabricated from suitable plastics meeting the requirements of the USP for class II plastics.
Catheter and needle point protector shall be fabricated from a suitable plastic.
Construction. The unit shall permit aseptic insertion by the surgeon without assistance and without the necessity of hand-scrubbing or wearing sterile gloves. Shall consist of an outer plastic 16 gauge catheter permanently secured to a plastic Luer-lock hub. The catheter hub shall be in accordance with ANSI-HIMA MD70.1. The catheter length shall be 8 ± 1/4 inches.
The heel of the needle bevel shall extend beyond the catheter tip when the needle is fully inserted into the catheter. A flow control or self-venting plug shall be assembled to the needle hub.
The needle cannula shall make a free-sliding fit within the catheter. Needle point shall be well defined.
Catheters shall not pull out or loosen from the catheter hub when subjected to an axial force of 3.0 pounds. Catheters shall not exhibit leakage exceeding one clinging drop (hydrostatic test) when tested with appropriate fixtures and taper test gauges. The criteria shall be as follows:
Hydrostatic test. Twenty pounds per square inch gauge (psig) pressure applied for two minutes.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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