CSA ISO 14971
Medical devices - Application of risk management to medical devices
active, Most Current
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| Organization: | CSA |
| Publication Date: | 1 January 2007 |
| Status: | active |
| Page Count: | 100 |
| 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
January 1, 2021
Medical devices - Application of risk management to medical devices
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
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...
CSA ISO 14971
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...