NEN-EN-ISO 14971/A1
Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements
inactive
| Organization: | NEN |
| Publication Date: | 1 April 2003 |
| Status: | inactive |
| Page Count: | 16 |
| ICS Code (Medical equipment in general): | 11.040.01 |
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...
NEN-EN-ISO 14971/A1
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.
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,...