DIN EN ISO 14971:2009
医疗设备.风险管理在医疗设备上的应用(ISO 14971:2007,修订版2007-10-01),德文版本 EN ISO 14971:2009

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); English version of DIN EN ISO 14971:2009-10

作废

标准号

DIN EN ISO 14971:2009

发布

2009年

发布单位

德国标准化学会

替代标准

DIN EN ISO 14971:2013

当前最新

DIN EN ISO 14971:2020

 

 

适用范围

This International 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. The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device. This International Standard does not apply to clinical decision making. This International Standard does not specify acceptable risk levels. This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

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