标准摘要
[中文适用范围]： 此文件规定了与用于体外血液治疗的透析设备配套使用的一次性体外血和液路及附件的要求，如但不限于透析、血液透滤过和血液滤过。此文件不适用于：—— 血透器、血液透滤器或血液滤器；—— 血浆过滤器；—— 血液灌流装置；—— 脉管接入设备。注1 血透器、血液透滤器、血液滤器和血浓缩器的要求规定在ISO 8637-1中。注2 血浆过滤器的要求规定在ISO 8637-3中。 [外文原描述]： This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — plasmafilters; — haemoperfusion devices; — vascular access devices. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1. NOTE 2 Requirements for plasmafilters are specified in ISO 8637-3.
英文名称Extracorporeal systems for blood purification — Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators