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ISO 14971

Medical devices - Application of risk management to medical devices

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Organization: ISO
Publication Date: 1 March 2007
Status: active
Page Count: 90
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

Document History

May 9, 2019
Medical devices — Application of risk management to medical devices
This document specifies terminology, principles and a process for Kk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
ISO 14971
March 1, 2007
Medical devices - Application of risk management to medical devices
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...
December 15, 2000
Medical Devices - Application of Risk Management to Medical Devices
A description is not available for this item.
December 15, 2000
Medical Devices - Application of Risk Management to Medical Devices
This International Standard specifies a procedure by which a manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical...

References

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