JIS T 14971:2012現行
Medical devices - Application of risk management to medical devices
出版：Japanese Standards Association
專家解讀視頻
基本信息
標準編號： JIS T 14971:2012
發布時間：2012/3/1 0:00:00
標準類別：Standard
出版單位：Japanese Standards Association
標準頁數：88
標準簡介
This Japanese Industrial Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this Standard are applicable to all stages of the life-cycle of a medical device.
本標準替代的舊標準
