ISO 8637-2:2024 血液净化用体外系统 第2部分：血液透析器、血液透析滤过器和、血液滤过器和血液浓缩器用体外血液和流体回路

标准编号：ISO 8637-2:2024

中文名称：血液净化用体外系统 第2部分：血液透析器、血液透析滤过器和、血液滤过器和血液浓缩器用体外血液和流体回路

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

发布日期：2024-04

标准范围

本文件规定了与血液透析设备结合使用的一次性体外血液和流体回路及附件的要求，血液透析设备用于体外血液治疗疗法，如但不限于血液透析、血液透析滤过、血液滤过。本文件不适用于:-血液透析器、血液透析滤器或血液滤器；-等离子体过滤器;-血液灌注装置；-血管通路装置。注1血液透析器、血液透析滤器、血液滤器和血液浓缩器的要求见ISO 8637-1。注2血浆过滤器的要求见ISO 8637-3。

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.

标准预览图