使用动物组织及其衍生物的医疗设备 - 第2部分:采购 收集和处理控制

[中文适用范围]： 本文件规定了对使用动物源材料制造医疗器械（体外诊断医疗器械除外）的动物和组织的采购、收集和处理（包括储存和运输）的控制要求。 它适用于 ISO 22442-1 中描述的风险管理流程的要求。 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，即在使用源自牛、绵羊和山羊、鹿、麋鹿、水貂或猫的动物组织和/或其衍生物时。 本文件不涵盖人体组织在医疗器械中的利用。 本文件没有规定用于控制医疗器械生产所有阶段的质量管理体系。 [外文原描述]： 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.