
Medical devices - Application of risk management to medical devices
出版:Japanese Standards Association

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基本信息
标准编号: JIS T 14971:2012
发布时间:2012/3/1 0:00:00
标准类别:Standard
出版单位:Japanese Standards Association
标准页数:88
标准简介
This Japanese Industrial Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic medical devices to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this Standard are applicable to all stages of the life-cycle of a medical device.
本标准替代的旧标准