ISO 22442-2:2020 利用动物组织及其衍生物的医疗设备 第2部分：对来源、收集和处理的控制

标准编号：ISO 22442-2:2020

中文名称：利用动物组织及其衍生物的医疗设备 第2部分：对来源、收集和处理的控制

英文名称：Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling

发布日期：2020-09

标准范围

本文件规定了使用非体外诊断医疗器械的动物源性材料制造医疗器械所需的动物和组织的采购、收集和处理（包括储存和运输）控制要求。它适用于ISO 22442-1中所述的风险管理流程要求的情况。注:选择性采购对于传染性海绵状脑病（TSE）风险管理尤其重要，即当使用来自牛、绵羊和山羊物种、鹿、麋鹿、水貂或猫的动物组织和/或其衍生物时。本文件不包括人体组织在医疗设备中的应用。本文件未规定医疗器械生产所有阶段的质量管理体系。

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442？1.NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.This document does not cover the utilization of human tissues in medical devices.This document does not specify a quality management system for the control of all stages of production of medical devices.

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