This standard specifies the classification and structure, requirements, testing methods, marks, labels, instructions for use, packaging, transportation and storage of aseptic disposable arteriovenous cannula (hereinafter referred to as Arteriovenous cannula). This standard is suitable for arteriovenous cannula supporting cardiopulmonary bypass system. It is used for drainage or perfusion of blood during direct vision cardiac operation of cardiopulmonary bypass (CPB).
Basic Data
Standard ID
YY 0948-2015 (YY0948-2015)
Description (Translated English)
Cardiopulmonary bypass systems. Arteriovenous cannula for single use
Sector / Industry
Medical Device and Pharmaceutical Industry Standard
The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies)
State Food and Drug Administration
Summary
This Standard specifies the classification and structure of single-use sterile arteriovenous cannula, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This Standard applies to vascular catheter, for supporting cardiopulmonary bypass system used for drainage or perfusion of blood during open heart surgery during cardiopulmonary bypass purposes.
