
Medical Devices - Application Of Risk Management To Medical Devices
出版:Italian Standards

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基本信息
标准编号: UNI CEI EN ISO 14971:2009
标准类别:Standard
出版单位:Italian Standards
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.
标准备注
Supersedes UNI EN 1441. (05/2002) 2004 version remains active until 10 March 2010. (09/2009)
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