DS/EN ISO 14971
Medical devices - Application of risk management to medical devices
inactive
| Organization: | DS |
| Publication Date: | 2 July 2008 |
| Status: | inactive |
| Page Count: | 178 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
This standard specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. The requirements of this standard are applicable to all stages of the life-cycle of a medical device. This standard does not apply to clinical decision making. This standard does not specify acceptable risk levels. This 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 14, 2021
Medical devices – Application of risk management to medical devices (ISO 14971:2019)
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...
January 2, 2020
Medical devices – Application of risk management to medical devices (ISO 14971:2019)
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...
December 21, 2012
Medical devices – Application of risk management to medical devices
ISO 14971:2007 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...
August 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...
September 30, 2009
Medical devices - Application of risk management to medical devices
This standard specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate...
DS/EN ISO 14971
July 2, 2008
Medical devices - Application of risk management to medical devices
This standard specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate...
April 10, 2007
Medical devices - Application of risk management to medical devices
This standard specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate...
April 19, 2005
Medical devices - Application of risk management to medical devices
This standard specifies a procedure by which the manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical devices, estimate...
April 30, 2003
Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements
As explained in the Introduction, a risk management system applying to all medical devices is required. Risks exist throughout the product life cycle, and risks that become apparent at one point in...
March 20, 2001
Medical devices - Application of risk management to medical devices
This standard specifies a procedure by which the manufacturer can identify the hazards associated with medical devices and their accessories, including in vitro diagnostic medical devices, estimate...
Medical devices – Application of risk management to medical devices (ISO/FDIS 14971:2019)
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic (IVD) medical devices. The process...
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
This standard specifies a process for a manufacturer to identify the hazards and hazardous situations associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate...
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