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

DIN EN ISO 14971-2009 发布历史

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.

DIN EN ISO 14971-2009由德国标准化学会 DE-DIN 发布于 2009-10，并于 2009-10-01 实施。

DIN EN ISO 14971-2009 在中国标准分类中归属于: C30 医疗器械综合，在国际标准分类中归属于: 11.040.01 医疗设备综合,11.120.01 制药学综合。

DIN EN ISO 14971-2009的历代版本如下：

• 2007年07月 DIN EN ISO 14971-2007 医疗设备.医疗设备风险管理的应用(ISO 14971-2007)
• 2009年10月 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
• 2013年04月 DIN EN ISO 14971-2013 医疗器械. 风险管理在医疗器械上的应用 (ISO 14971-2007, 修正版本2007-10-01); 德文版本EN ISO 14971-2012

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标准号

DIN EN ISO 14971-2009

发布日期

2009年10月

实施日期

2009年10月01日

废止日期

无

中国标准分类号

C30

国际标准分类号

11.040.01;11.120.01

发布单位

DE-DIN

代替标准

DIN EN ISO 14971-2013

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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