This standard specifies the terms and definitions,modes,composition,basic parameters,requirements,test methods,marking,packaging,transportation and storage of cardiopulmonary bypass system—roller blood pump.
This standard is applicable to cardiopulmonary bypass system—roller blood pump (hereafter referred to as the blood pump).This product is temporarily used for extracorporeal circulation or regional perfusion in place of cardiac function in the operation and rescue of medical units. |
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