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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
標(biāo)準(zhǔn)編號： DS EN ISO 22442-1:2008
發(fā)布時(shí)間：2008/2/22 0:00:00
標(biāo)準(zhǔn)類別：Standard
出版單位：Danish Standards
標(biāo)準(zhǔn)頁數(shù)：40
標(biāo)準(zhǔn)簡介
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.
替代本標(biāo)準(zhǔn)的新標(biāo)準(zhǔn)
等同采用的國際標(biāo)準(zhǔn)
EN ISO 22442-1:2015 - Identical
