NEN-EN-ISO 14971
Medical devices - Application of risk management to medical devices
inactive
| Organization: | NEN |
| Publication Date: | 1 February 2001 |
| Status: | inactive |
| Page Count: | 44 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
Specifies a procedure for the manufacturer to identify the hazards associated with medical devices and their accessories, including in vitro diagnostic devices, estimate and evaluate the risks, control these risks and monitor the effectiveness of the control. The requirements of this standard are applicable to all stages of the life cycle of a medical device.
Document History
December 1, 2021
Medical devices - Application of risk management to medical devices
A description is not available for this item.
December 1, 2019
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...
August 1, 2009
Medical devices - Application of risk management to medical devices (corrected and reprinted)
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...
March 1, 2007
Medical devices - Application of risk management to medical devices (corrected and reprinted 2012-07)
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...
March 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...
October 1, 2005
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 1, 2003
Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements
A description is not available for this item.
November 1, 2001
Medical devices - Application of risk management to medical devices
A description is not available for this item.
NEN-EN-ISO 14971
February 1, 2001
Medical devices - Application of risk management to medical devices
Specifies a procedure for the manufacturer to identify the hazards associated with medical devices and their accessories, including in vitro diagnostic devices, estimate and evaluate the risks,...
August 1, 1999
Medical devices - Application of risk management to medical devices
Specifies a procedure for the manufacturer to identify the hazards associated with medical devices and their accessories, including in vitro diagnostic devices, estimate and evaluate the risks,...