標準號：ISO 22442-1-2007
中文標準名稱：醫療設備用動物組織及其衍生物.第1部分:風險管理的應用
英文標準名稱：Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
標準類型：C37
發布日期：2007/12/1 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C37
國際標準分類號：11.100.20
適用范圍：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 ofproduction 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 allstages of production or reprocessing of medical devices.NOTE 2 For guidance on the application of this part of ISO 22442 see Annex A.