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

ISO 8637-1:2017规定了用于人体的血液透析器、血液透析过滤器、血液过滤器和血液浓缩器（以下统称为“设备”）的要求。ISO 8637-1:2017不适用于:-体外血液循环；-等离子过滤器；-血液灌流装置；-血管通路装置；-血泵；-体外血液回路的压力监测器；-空气探测装置；-准备、维护或监测透析液的系统；-用于进行血液透析、血液透析滤过、血液滤过或血液浓缩的系统或设备；-再加工程序和设备。注:血液透析器、血液透析过滤器和血液过滤器的体外血液回路要求见ISO 8637-2。

ISO 8637-1:2017 specifies requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators, hereinafter collectively referred to as "the device", for use in humans.ISO 8637-1:2017 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