UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

BSI - BS EN ISO 14971

Medical devices - Application of risk management to medical devices

inactive
Buy Now
Organization: BSI
Publication Date: 31 July 2009
Status: inactive
Page Count: 96
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

December 31, 2019
Medical devices - Application of risk management to medical devices
A description is not available for this item.
December 31, 2019
Medical devices - Application of risk management to medical devices
A description is not available for this item.
July 31, 2012
Medical devices - Application of risk management to medical devices
A description is not available for this item.
July 31, 2009
Medical devices - Application of risk management to medical devices
A description is not available for this item.
BS EN ISO 14971
July 31, 2009
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...
April 30, 2007
Medical devices - Application of risk management to medical devices
A description is not available for this item.
March 15, 2001
Medical Devices - Application of Risk Management to Medical Devices
A description is not available for this item.
March 15, 2001
Medical Devices - Application of Risk Management to Medical Devices
A description is not available for this item.
March 15, 2001
Medical Devices - Application of Risk Management to Medical Devices
A description is not available for this item.

References

Advertisement