本文件适用于制造的体外诊断医疗设备以外的医疗设备 使用动物来源的材料，这些材料是不可行的或已经变得不可行。信息技术 结合ISO 14971规定了识别危险和危险情况的程序 与此类设备相关，以估计和评估由此产生的风险，控制这些风险， 并监督控制的有效性。此外，它还概述了项目的决策过程 剩余风险可接受性，考虑ISO 14971中定义的剩余风险平衡，以及 与可用替代品相比的预期医疗效益。本文件旨在提供 与医疗器械典型危害相关的风险管理要求和指南 利用动物组织或衍生物制造，例如: a） 细菌、霉菌或酵母菌污染；b） 病毒污染；c） 导致传染性海绵状脑病（TSE）的病原体污染；d） 引起不期望的热原、免疫或毒理学反应的材料。 对于寄生虫和其他未分类的致病实体，类似的原则也适用。

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for the residual risk acceptability, taking into account the balance of residual risk, as defined in ISO 14971, and expected medical benefit as compared to available alternatives. This document is intended to provide requirements and guidance on risk management related to the hazards typical of medical devices manufactured utilizing animal tissues or derivatives such as: a) contamination by bacteria, moulds or yeasts;b) contamination by viruses;c) contamination by agents causing transmissible spongiform encephalopathies (TSE);d) material responsible for undesired pyrogenic, immunological or toxicological reactions. For parasites and other unclassified pathogenic entities, similar principles can apply.