DIN EN ISO 22442-1-2008 医疗设备用动物组织及其衍生物.第1部分:风险管理的应用

标准号：DIN EN ISO 22442-1-2008
中文标准名称：医疗设备用动物组织及其衍生物.第1部分:风险管理的应用
英文标准名称：Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2007); English version of DIN EN ISO 22442-1:2008-03
标准类型：C37
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C37
国际标准分类号：11.100.99
引用标准：ISO 10993-1;ISO 14971-2007;ISO 22442-2;ISO 22442-3
适用范围：This part of ISO 22442 applies to medical devices other than in vitro diagnostic medical devices manufacturedutilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, inconjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated withsuch devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor theeffectiveness 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 ascompared to available alternatives. This part of ISO 22442 is intended to provide requirements and guidanceon risk management related to the hazards typical of medical devices manufactured utilizing animal tissues orderivatives 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 part of ISO 22442 does not stipulate levels of acceptability which, because they are determined by amultiplicity of factors, cannot be set down in such an International Standard except for some particularderivatives 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 part of ISO 22442 does not specify a quality management system for the control of all stages of production of medical devices. This part of ISO 22442 does not cover the utilization of human tissues in medical devices. NOTE 1 It is not a requirement of this part of ISO 22442 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 part of ISO 22442 see Annex A.