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DS EN ISO 22442-1:2008被替代

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

出版:Danish Standards

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基本信息
标准编号: DS EN ISO 22442-1:2008
发布时间:2008/2/22 0:00:00
标准类别:Standard
出版单位:Danish Standards
标准页数:40
标准简介

Pertains 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 also defines, 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

DS EN ISO 22442-1:2015

等同采用的国际标准

EN ISO 22442-1:2015 - Identical