
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
出版:Standardiserings-Kommissionen I Sverige

专家解读视频
基本信息
标准编号: SS-EN ISO 14971 : 2012
标准类别:Standard
出版单位:Standardiserings-Kommissionen I Sverige
标准页数:0
标准简介
ISO 14971:2007 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.