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CSA - CAN/CSA-ISO 14971-01

Medical Devices - Application of Risk Management to Medical Devices

inactive
Organization: CSA
Publication Date: 1 September 2001
Status: inactive
Page Count: 57
scope:

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 devices, estimate and evaluate the risks. control these risks and monitor the effectiveness of the control.

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 judgements relating to the use of a medical device.

It does not specify acceptable risk levels.

This International Standard does not require that the manufacturer has a formal quality system in place. However, risk management can be an integral part of a quality system (see, for example, Table G.1).

Document History

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...
CAN/CSA-ISO 14971-01
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...
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