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

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

被代替

标准号

DIN EN ISO 22442-1:2008

发布

2008年

发布单位

德国标准化学会

替代标准

DIN EN ISO 22442-1:2016

当前最新

DIN EN ISO 22442-1:2016

DIN EN ISO 22442-1:2018

 

 

引用标准

ISO 10993-1 ISO 14971:2007 ISO 22442-2 ISO 22442-3

被代替标准

DIN EN ISO 22442-1:2006 DIN EN 12442-1:2001

适用范围

This part of ISO 22442 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 part of ISO 22442 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 part of ISO 22442 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 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.

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