标准号：ISO 22442-1-2007
实施状态：作废
中文名称：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
英文名称：Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
发布日期：2007-12-01
被替代标准：ISO 22442-1-2015
代替标准：ISO/FDIS 22442-1-2007
采用标准：DIN EN ISO 22442-1-2008,IDT;ANSI/AAMI/ISO 22442-1-2007,IDT;BS EN ISO 22442-1-2008,IDT;EN ISO 22442-1-2007,IDT;NF S97-601-1-2008,IDT;SN EN ISO 22442-1-2008,IDT;OENORM EN ISO 22442-1-2008,IDT;PN-EN ISO 22442-1-2008,IDT;UNE-EN ISO 22442-1-2008,IDT
起草单位：ISO/TC 194
标准简介：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.
文件格式：PDF
文件大小：650.55KB
文件页数：34
（以上信息更新时间为：2019-11-22）
ISO 22442-1-2007 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.pdf
(650.55 KB)
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