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
專家解讀視頻
基本信息
標準編號： NEN EN ISO 22442-1:2006
發布時間：2006/6/1 0:00:00
標準類別：Draft
出版單位：Nederlands Normalisatie Instituut
標準頁數：31
標準簡介
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.
替代本標準的新標準
等同采用的國際標準
ISO/DIS 22442-1 - Identical
