ISO 8637-1:2024 血液净化用体外系统 第1部分：血液透析器、血液透析滤过器、血液滤过器和血液浓缩器

标准编号：ISO 8637-1:2024

中文名称：血液净化用体外系统 第1部分：血液透析器、血液透析滤过器、血液滤过器和血液浓缩器

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

发布日期：2024-05

标准范围

本文件规定了用于人体的血液透析器、血液透析滤器、血液滤器和血液浓缩器（以下统称为“器械”）的要求和测试方法。本文件不适用于:-体外血液回路；-等离子体过滤器;-血液灌注装置；-血管通路装置；-血泵；-用于制备、维持或监测透析流体的系统；-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；-后处理程序和设备。注1血液透析器、血液透析滤器和血液滤器的体外血液回路要求见ISO 8637-2。注2血浆过滤器的要求见ISO 8637-3。

This document specifies requirements and test methods 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;

—     systems to prepare, maintain or monitor dialysis fluid;

—     systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration;

—     reprocessing procedures and equipment.

NOTE 1       Requirements for extracorporeal blood circuits for haemodialysers, haemodiafilters and haemofilters are specified in ISO 8637-2.

NOTE 2       Requirements for plasmafilters are specified in ISO 8637-3.

标准预览图