标准摘要
[中文适用范围]： 本文件规定了无菌、一次性、体外硬壳心脏切开术/静脉储血系统和软静脉储血袋的要求，这些系统旨在用作心肺旁路 (CPB) 手术期间的血液储血器。本文件仅适用于多功能系统的血液储血器方面，该系统可以具有血气交换器（氧合器）、血液过滤器、消泡器、血泵等集成部件。 [外文原描述]： ISO 15674:2016 specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery. It applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.
英文名称Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags