ISO 8637-3:2024 血液净化用体外系统 第3部分：血浆滤过器

标准编号：ISO 8637-3:2024

中文名称：血液净化用体外系统 第3部分：血浆滤过器

英文名称：Extracorporeal systems for blood purification — Part 3: Plasmafilters

发布日期：2024-05

标准范围

本文件规定了血浆过滤器的要求和测试方法，血浆过滤器是用于在治疗性血浆置换治疗中从血液中分离血浆的设备。本文件规定了用于人体的无菌一次性血浆过滤器（以下统称为“器械”）的要求。本文件不适用于:-体外血液回路；-血液透析器、血液透析滤器、血液滤器和血液浓缩器；-血液灌注装置；-血管通路装置；-血泵；-用于进行血浆分离的系统或设备。注1体外血液回路的要求见ISO 8637-2。注2 ISO 8637-1规定了血液透析器、血液透析滤器、血液滤器和血液浓缩器的要求。

This document specifies requirements and test methods for plasmafilters, which are devices intended to separate plasma from blood in therapeutic plasmapheresis therapy. This document specifies the requirements for sterile, single-use plasmafilters, intended for use on humans, hereinafter collectively referred to as “the device”, for use in humans. This document does not apply to;

—     extracorporeal blood circuits;

—     haemodialysers, haemodiafilters, haemofilters and haemoconcentrators;

—     haemoperfusion devices;

—     vascular access devices;

—     blood pumps;

—     systems or equipment intended to perform plasma separation.

NOTE 1       Requirements for the extracorporeal blood circuit are specified in ISO 8637-2.

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

标准预览图