标准编号:ISO 15674:2016
中文名称: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
英文名称:Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
发布日期:2016-08
标准范围
This document 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.This document 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.