This standard specifies the classification and structure, requirements, test methods, markings, labels, instructions for use, packaging, transportation, and storage of sterile suction catheter for single use (hereinafter referred to as suction catheter). This standard applies to suction catheters, for supporting cardiopulmonary bypass system, suction catheter for cardiovascular ventilation in the left heart, suction decompression or reduction of left heart load, to attract the intracardiac blood and other fluids.
Basic Data
Standard ID
YY 1271-2016 (YY1271-2016)
Description (Translated English)
Cardiopulmonary bypass systems. Suction catheter for single use
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
Notice of the General Administration of Food and Drug Administration (No. 74 of 2016)
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the classification and construction, requirements, test methods, marking, labeling, instruction manuals, packaging, transport and storage of sterile disposable suction tubes. This standard applies to the suction tube, for supporting the cardiopulmonary bypass system to attract the tube for cardiovascular surgery for the left heart exhaust, to attract or reduce the left ventricular load decompression, cardiac surgery to attract blood and other liquid use.
