ANSI/AAMI/ ISO 14971:2019现行
Medical devices—Application of risk management to medical devices
出版：Association for the Advancement of Medical Instrumentation
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基本信息
标准编号： ANSI/AAMI/ ISO 14971:2019
标准类别：Standard
出版单位：Association for the Advancement of Medical Instrumentation
标准页数：46
标准简介
This standard 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.
本标准替代的旧标准
