ISO/DIS 14971被替代
Medical devices - Application of risk management to medical devices
出版：International Organization for Standardization
專家解讀視頻
基本信息
標準編號： ISO/DIS 14971
標準類別：Draft
出版單位：International Organization for Standardization
標準頁數：0
標準簡介
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.
