
MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007, CORRECTED VERSION 2007-10-01)
出版:German Institute for Standardisation (Deutsches Institut für Normung)

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基本信息
标准编号: DIN EN ISO 14971 E : 2013
标准类别:Standard
出版单位:German Institute for Standardisation (Deutsches Institut für Normung)
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.