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CEN - EN ISO 14971

Medical devices - Application of risk management to medical devices

active, Most Current
Organization: CEN
Publication Date: 1 July 2012
Status: active
Page Count: 106
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

EN ISO 14971
July 1, 2012
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...
July 1, 2009
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...
March 1, 2007
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...
December 1, 2000
Medical Devices - Application of Risk Management to Medical Devices
A description is not available for this item.
December 1, 2000
Medical Devices - Application of Risk Management to Medical Devices
A description is not available for this item.

References

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