ANSI/AAMI/ ISO 14971:2019現行
Medical devices—Application of risk management to medical devices
出版：Association for the Advancement of Medical Instrumentation
專家解讀視頻
基本信息
標準編號： ANSI/AAMI/ ISO 14971:2019
標準類別：Standard
出版單位：Association for the Advancement of Medical Instrumentation
標準頁數：46
標準簡介
This standard specifies 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.
本標準替代的舊標準
