Standard Number: YY 0603-2015(YY0603-2015)
Chinese:心血管植入物及人工器官 心脏手术硬壳贮血器/静脉贮血器系统（带或不带过滤器）和静脉贮血软袋
English:Cardiovascular implants and artificial organs-Hard-shell cardiotomy/venous reservoir systems(with/without filter)and soft venous reservoir bags
Effective Date:2017-01-01
ICS:11.040.40
Standard Applicability:This standard applies to blood storage devices for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), blood filters, expectorators, and blood pumps. This standard specifies the requirements for test methods, marking, labeling, instructions for use, packaging, transportation and storage of sterile, single-use extracorporeal circulation cardiac surgical hard-shell blood storage devices, venous blood storage systems (with or without filters) and venous blood storage soft bags (referred to as blood storage devices). The above devices are intended to be used for cardiopulmonary bypass (CPB) when blood storage. This standard replaces YY 0603-2007 “Cardiovascular implants and artificial organs Cardiac surgical hard shells Blood storage device / venous blood storage system (with or without filters) and venous blood storage soft bags”.
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