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NEN EN ISO 22442-1:2006被替代

Medical Devices Utilizing Animal Tissues And Their Derivatives - Part 1: Application Of Risk Management

出版:Nederlands Normalisatie Instituut

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基本信息
标准编号: NEN EN ISO 22442-1:2006
发布时间:2006/6/1 0:00:00
标准类别:Draft
出版单位:Nederlands Normalisatie Instituut
标准页数:31
标准简介

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.

替代本标准的新标准

NEN EN ISO 22442-1:2008

等同采用的国际标准

ISO/DIS 22442-1 - Identical