ANSI/AAMI/ISO 14971:2007
医疗装置.医疗装置风险管理的应用

Medical devices - Application of risk management to medical devices

被代替

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标准号

ANSI/AAMI/ISO 14971:2007

发布

2007年

发布单位

US-AAMI

替代标准

ANSI/AAMI/ISO 14971:2019

当前最新

ANSI/AAMI/ISO 14971:2019

 

 

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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