
Medical devices - Application of risk management to medical devices
出版:International Organization for Standardization

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基本信息
标准编号: ISO/DIS 14971
标准类别:Draft
出版单位:International Organization for Standardization
标准页数:0
标准简介
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.