ISO 8637-2:2018 血液净化体外系统 第2部分：血液透析仪、血液透析过滤器和血液过滤器的体外血液循环

标准编号：ISO 8637-2:2018

中文名称：血液净化体外系统 第2部分：血液透析仪、血液透析过滤器和血液过滤器的体外血液循环

英文名称：Extracorporeal systems for blood purification — Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

发布日期：2018-07

标准范围

本文件规定了用于体外血液过滤疗法的设备的血液回路要求，例如但不限于血液透析、血液透析滤过、血液滤过和用于此类回路的传感器保护器（整体式和非整体式）。本文件不适用于:-血液透析器、血液透析过滤器或血液过滤器；-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。注1:ISO 8637-1规定了血液透析器、血液透析过滤器、血液过滤器和血液浓缩器的要求，ISO 8637-3规定了血浆过滤器的要求。注2:体外血液导管组也可用于其他体外治疗，如血液灌流、血浆过滤和血浆吸附。

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits.This document does not apply to:— haemodialysers, haemodiafilters or haemofilters;— 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.NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637？1, and requirements for plasmafilters are specified in ISO 8637？3.NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

标准预览图