ISO 8637-3:2018 血液净化体外系统 第3部分：血浆过滤器

标准编号：ISO 8637-3:2018

中文名称：血液净化体外系统 第3部分：血浆过滤器

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

发布日期：2018-07

标准范围

本文件规定了等离子过滤器安全相关参数的要求和验收标准（包括试验方法）。仅包括等离子体过滤器的特定要求。它规定了用于人体的一次性无菌血浆过滤器的要求。本文件不包括与毒性有关的事项。ISO 10993的相关部分涵盖了此类问题。它不适用于可用于血浆置换血管通路设备、氧合器或主动医疗设备的体外回路。本文件不涉及更换液。

This document specifies requirements and acceptance criteria (including test methods) for safety related parameters for plasmafilters. Only those requirements that are specific to plasmafilters have been included.It specifies requirements for sterile, single-use plasmafilters, intended for use on humans.This document does not cover matters related to toxicity. Such issues are covered in relevant parts of ISO 10993.It does not apply to the extracorporeal circuits that can be used for plasmapheresis vascular access devices, oxygenators or active medical devices. This document does not address the replacement fluid.

标准预览图