A-A-54154
The flow control plug shall have a Luer taper to provide leakproof seal with the catheter hub. A protective sleeve, covering from the needle collar to over the flow control plug, shall maintain the sterility of the catheter unit opened.
Catheter hub and flow control plug. The female Luer-lock fitting on the catheter hub and the male Luer slip fitting on the flow control plug shall comply with the dimensional and performance requirements of ANSI/HIMA Standard MD70.1.
Catheter flexibility. With the wire stylet removed, the catheter shall be wrapped 360 degrees around a 3/8 inch diameter rod without kinking or cracking. Water shall then be admitted through the catheter hub within 5 seconds of being removed from the rod and observed for restricted flow from the distal tip.
Security of assembly. When the following joints are subjected to the indicated tensile forces, they shall not separate or pull apart: 16 gage catheter to hub-5 pounds, 18.5 or 19 gage catheter to hub 2-pounds, 22 gage catheter to hub 1-pound, flow control plug to wire stylet - 1.5 pounds minimum, protective sleeve to needle collar- 3 pounds, and needle (lumen) to hub- 10 pounds.
Catheter/hub leakage. The catheter/hub joint shall not leak when subjected to the water leakage test specified in ANSI/HIMA MD70.1. As an alternate, the joint shall not show leakage of air bubbles when checked underwater for 6 seconds with 35 psig air for Type I or II catheters, and 1 minute with psig air if Type III catheter.
Radiopacity. Catheters shall be radiopaque in accordance with ASTM Designation F640.
Heavy metals extractability. Plastic components coming in contact with intravenous solution or patient’s blood shall be tested. The quantity of lead and cadmium shall not exceed 5 parts per million (ppm) and the amount of barium shall not exceed 10 ppm when tested in accordance with the USP (See Note 3).
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