使用动物组织及其衍生物的医疗设备 - 第1部分:风险管理的应用

[中文适用范围]： 本文件适用于除利用动物源材料制造的非活性或已变得非活性的体外诊断医疗器械之外的医疗器械。 它与 ISO 14971 一起规定了一个程序，用于识别与此类设备相关的危险和危险情况，估计和评估由此产生的风险，控制这些风险，并监控该控制的有效性。 此外，它概述了残余风险可接受性的决策过程，考虑了 ISO 14971 中定义的残余风险的平衡，以及与可用替代方案相比的预期医疗效益。 本文件旨在提供与利用动物组织或衍生物制造的医疗器械的典型危害相关的风险管理要求和指导，例如： a) 细菌、霉菌或酵母菌污染； b) 病毒污染； c) 引起传染性海绵状脑病（TSE）的病原体污染； d) 引起不良热原、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，可以应用类似的原则。 本文件没有规定可接受水平，因为它们是由多种因素决定的，因此除了附件 C 中提到的一些特定衍生品外，不能在这样的国际标准中规定可接受水平。 附件 C 规定了 TSE 对牛脂衍生品的风险可接受水平、动物木炭、牛奶和牛奶衍生物、羊毛衍生物和氨基酸。 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。 本文件不涵盖人体组织在医疗器械中的利用。 注 1：本文件不要求在制造过程中拥有完整的质量管理体系。 然而，人们关注控制医疗器械生产或再加工所有阶段的质量管理体系国际标准（参见 ISO 13485）。 注 2：有关本文件应用的指导，请参见附录 A。 [外文原描述]： 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. This document does not stipulate levels of acceptability which, because they are determined by a multiplicity of factors, cannot be set down in such an international standard except for some particular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability for tallow derivatives, animal charcoal, milk and milk derivatives, wool derivatives and amino acids. This document does not specify a quality management system for the control of all stages of production of medical devices. This document does not cover the utilization of human tissues in medical devices. NOTE 1 It is not a requirement of this document to have a full quality management system during manufacture. However, attention is drawn to international standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. NOTE 2 For guidance on the application of this document, see Annex A.