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CSA - CAN/CSA-ISO 14971-07

Medical Devices - Application of Risk Management to Medical Devices

inactive
Organization: CSA
Publication Date: 1 May 2007
Status: inactive
Page Count: 100
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

CAN/CSA-ISO 14971-07
May 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...
May 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...
January 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...
September 1, 2001
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...
September 1, 2001
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...
September 1, 2001
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...
September 1, 2001
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, 1999
Medical Devices - Risk Management - Part 1: Application of Risk Analysis
This part of ISO 14971 specifies a procedure for investigating, using available information, the safety of a medical device, including in vitro diagnostic devices (IVD) or accessories, by identifying...

References

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