标准编号：ISO 22442-1:2015
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：2015-11
标准范围
This part of ISO 22442 applies to medical devices other than in vitro diagnostic medical devicesmanufactured utilizing materials of animal origin, which are non-viable or have been rendered nonviable.It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardoussituations associated with such devices, to estimate and evaluate the resulting risks, to control theserisks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process forthe 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 intendedto provide requirements and guidance on risk management related to the hazards typical of medicaldevices manufactured utilizing animal tissues or derivatives such asa) 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 determinedby a multiplicity of factors, cannot be set down in such an International Standard except for someparticular derivatives mentioned in Annex C. Annex C stipulates levels of TSE risk acceptability fortallow 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.
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