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
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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