DIN EN ISO 14971 E : 2013現行
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
出版：German Institute for Standardisation (Deutsches Institut für Normung)
專家解讀視頻
基本信息
標準編號： DIN EN ISO 14971 E : 2013
標準類別：Standard
出版單位：German Institute for Standardisation (Deutsches Institut für Normung)
標準頁數：0
標準簡介
Describes a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
