ISO 22442-1:2007 利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

标准编号：ISO 22442-1:2007

中文名称：利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

英文名称：Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management

发布日期：2007-12

标准范围

ISO 22442-1:20 07适用于除体外诊断医疗器械以外的医疗器械，这些医疗器械使用动物来源的材料制造，这些材料是无活力的或已经变得无活力的。它与ISO 14971一起规定了识别与此类器械相关的危害和危害情况、估计和评价由此产生的风险、控制这些风险以及监测控制有效性的程序。此外，它概述了剩余风险可接受性的决策过程，考虑了ISO 14971中定义的剩余风险的平衡，以及与可用替代方案相比的预期医疗益处。ISO 22442-1:20 07旨在提供与利用动物组织或衍生物制造的医疗器械典型危害相关的风险管理要求和指南，例如:被细菌、霉菌或酵母污染；病毒污染；引起传染性海绵状脑病(TSE)的物质污染；导致不良热原、免疫学或毒理学反应的物质。

ISO 22442-1:2007 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. ISO 22442-1:2007 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:

• contamination by bacteria, moulds or yeasts;
• contamination by viruses;
• contamination by agents causing Transmissible Spongiform Encephalopathies (TSE);
• material responsible for undesired pyrogenic, immunological or toxicological reactions.

标准预览图