DIN EN ISO 14971:2018-08
Superseded Draft standard
Historical

DIN EN ISO 14971:2018-08

Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
Most recent standard

Summary

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 described in this document intends to assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of this document are applicable to all stages of the life-cycle of a medical device.

Notes

Prévu pour remplacer DIN EN ISO 14971 (2013-04).

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 08/01/2018
Page Count 114
EAN ---
ISBN ---
Weight (in grams) ---
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Previous versions

DIN EN ISO 14971:2022-04

DIN EN ISO 14971:2022-04

Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
01/04/2022
Active
Most Recent
DIN EN ISO 14971:2020-07

DIN EN ISO 14971:2020-07

Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019
01/07/2020
Superseded
Historical
DIN EN ISO 14971:2018-08

DIN EN ISO 14971:2018-08

Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2018); German and English version prEN ISO 14971:2018
01/08/2018
Superseded
Historical
DIN EN ISO 14971:2013-04

DIN EN ISO 14971:2013-04

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007, Version corrigée de 2007-10-01); Version allemande EN ISO 14971:2012
01/04/2013
Superseded
Historical
DIN EN ISO 14971:2009-10

DIN EN ISO 14971:2009-10

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007, Version corrigée de 2007-10-01); Version allemande EN ISO 14971:2009
01/10/2009
Superseded
Historical
DIN EN ISO 14971/A1:2009-04

DIN EN ISO 14971/A1:2009-04

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); English version FprEN ISO 14971:2009, Amendment 1
01/04/2009
Superseded
Historical
DIN EN ISO 14971 Berichtigung 1:2007-10

DIN EN ISO 14971 Berichtigung 1:2007-10

Medical devices - Application of risk management to medical devices (ISO 14971:2007); German version EN ISO 14971:2007, Corrigenda to DIN EN ISO 14971:2007-07.
01/10/2007
Superseded
Historical
DIN EN ISO 14971:2007-07

DIN EN ISO 14971:2007-07

Dispositifs médicaux - Application de la gestion des risques aux dispositifs médicaux (ISO 14971:2007); Version allemande EN ISO 14971:2007
01/07/2007
Superseded
Historical
DIN EN ISO 14971:2005-11

DIN EN ISO 14971:2005-11

Medical devices - Application of risk management to medical devices (ISO/DIS 14971:2005); German version prEN ISO 14971:2005
01/11/2005
Superseded
Historical
DIN EN ISO 14971/A1:2003-10

DIN EN ISO 14971/A1:2003-10

Medical devices - Application of risk management to medical devices - Amendment 1: Rationale for requirements (ISO 14971:2000/AMD 1:2003); German version EN ISO 14971:2001/A1:2003
01/10/2003
Superseded
Historical
DIN EN ISO 14971/A1:2003-01

DIN EN ISO 14971/A1:2003-01

Medical devices - Application of risk management to medical devices; Amendment 1: Rationale for requirements (ISO 14971:2000/FDAM 1:2002); German version EN ISO 14971:2001/prA1:2002
01/01/2003
Superseded
Historical
DIN EN ISO 14971:2001-03

DIN EN ISO 14971:2001-03

Medical devices - Application of risk management to medical devices (ISO 14971:2000); German version EN ISO 14971:2000
01/03/2001
Superseded
Historical
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