ISO 8637-1:2017 血液净化体外系统 第1部分：血液透析器、血液过滤器、血液过滤器和血液浓缩器

标准编号：ISO 8637-1:2017

中文名称：血液净化体外系统 第1部分：血液透析器、血液过滤器、血液过滤器和血液浓缩器

英文名称：Extracorporeal systems for blood purification — Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

发布日期：2017-11

标准范围

This document specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to:
— extracorporeal blood circuits;
— plasmafilters;
— haemoperfusion devices;
— vascular access devices;
— blood pumps;
— pressure monitors for the extracorporeal blood circuit;
— air detection devices;
— systems to prepare, maintain or monitor dialysis fluid;
— systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;
— reprocessing procedures and equipment. NOTE Requirements for the extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.

标准预览图