CSA ISO 14971 : 2007現行
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
出版：Canadian Standards Association
專家解讀視頻
基本信息
標準編號： CSA ISO 14971 : 2007
標準類別：Standard
出版單位：Canadian Standards Association
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.
等同采用的國際標準
ISO 14971 : 2007(R2010) - Identical
