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ISO 14971:2007
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Medical devices -- Application of risk management to medical devices

This standard has been reviewed* and then confirmed in 2010.

*ISO standards are reviewed every five years.
This standard is also included in the online collection: Biological evaluation of medical devices.

Abstract

ISO 14971:2007 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 ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.

 

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