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

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基本信息
標準編號: UNI CEI EN ISO 14971:2009
標準類別:Standard
出版單位:Italian Standards
標準頁數:0
標準簡介
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.
標準備注
Supersedes UNI EN 1441. (05/2002) 2004 version remains active until 10 March 2010. (09/2009)
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