
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES
出版:Canadian Standards Association

专家解读视频
基本信息
标准编号: CSA ISO 14971 : 2007
标准类别:Standard
出版单位:Canadian Standards Association
标准页数:0
标准简介
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.
等同采用的国际标准
ISO 14971 : 2007(R2010) - Identical