A-A-51540 Catheter, Irrigation, Colonoscope

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A-A-51540

10 July 1986

COMMERCIAL ITEM DESCRIPTION

CATHETER, IRRIGATION, COLONOSCOPE

The General Services Administration has authorized the use of this commercial item description.

This commercial item description covers irrigation catheters suitable for use with a flexible colonoscope in endoscopic surgical procedures.

Salient characteristics:

General. The catheters shall be capable of passing through a 6 French accessory channel of a flexible fiberoptic colonoscope. The catheter shall be capable of withstanding repeated ethylene oxide sterilization or long term 10 hour soaking in percent glutaradehyde (tradename Cidex) solution.

Characteristics. The catheter shall be 210 centimeters (cm) plus 10 cm, minus 0 cm in length. The outside diameter of the catheter shall be 2 millimeters (mm) plus 0 mm, minus 0.1 mm. The inside diameter shall be 0.9 mm ± 0.05 mm. The distal tip shall be uniformly round and shall have a hole of 0.25 mm ± 0.02 mm in diameter. The catheter shall have a metal or rigid plastic female Luer slip connector attached to the proximal end. The Luer connector shall meet the dimensional requirements of American National Standards Institute/Health Industry Manufacturers Association (ANSI/HIMA) Standard MD70.1, for Medical Material-Luer Taper Fittings-Performance.

Materials. The catheter shall be manufactured from a suitable thermosensitive plastic. Metal Luer connectors shall be manufactured from passivated corrosion-resistant steel.

Biocompatibility. Plastic material shall be tested in accordance with the USP for Class IV plastics.

Workmanship. The workmanship of the catheters shall be first class throughout. The catheter shall be free from kinks, cracks, flashing, or foreign matter. There shall be no defects which affect the serviceability, appearance, or life of the catheters.

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.