A-A-51051
7 October 1985
COMMERCIAL ITEM DESCRIPTION
GUIDE WIRE, CARDIOVASCULAR CATHETER, Fixed Core, Heparin Coated
The General Service Administration has authorized the use of this commercial item description.
This commercial item description covers the requirements for a guide wire suitable for use during cardiac catheterization procedures.
Salient characteristics:
Shall be a sterile, straight, fixed core guide wire, 0.035 inch (0.89 cm) in diameter and 145 cm long.
The guide shall be constructed of tightly spiraled wire overt the fixed core surface. The end of the guide shall have a 3 cm flexible tip.
A microtin polytetrafluoroethylene coating shall be applied to the fixed core to reduce friction in the catheter. The guide wire shall have a borded heparin coating.
The entire guide wire shall be protected within a plastic guide higher the holder shall be color coded by guide diameter facilitating identification and accurate handling during insertion of the guide.
The guide wire shall be nontoxic and pyroger free and shall meet any Federal Food and Drug Administration (FDA) requirements for safety and toxicity applicable for invasive and implartable devices.
Each wire guide shall be individually wrapped in a suitable, tear-resitant, peel-open package which will allow aseptic handling and maintain sterility of the contents until opened or damaged. A sterility indicator shall be included in each package. The sterility of the guide wire shall be tested in accordance with the USF.
The guide wire with the plastic holder shall be capable of withstanding ethylene oxide sterilization. The guide wire without the plastic holder shall withstand steam sterilization.
The guide wire shall be fabricated from type 302 austeritic corrosion-resisting steel.
Workmanship. The guide wire shall be free from defects which detract from its appearance or impair its serviceability.
Unit. Each (EA). One guide wire, as specified, constitutes one unit.
DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.
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