DIN EN ISO 22442-1:2018-09
Superseded Draft standard
Historical

DIN EN ISO 22442-1:2018-09

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018
Most recent standard

Summary

This Part of ISO 22442 applies to medical devices other than in-vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to investigate, using available information, the safety of such devices by estimating and evaluating the resulting risks, controlling these risks and monitoring the effectiveness of that control.

Notes

Prévu pour remplacer DIN EN ISO 22442-1 (2016-05).

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 09/01/2018
Page Count 73
EAN ---
ISBN ---
Weight (in grams) ---
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Previous versions

DIN EN ISO 22442-1:2021-08

DIN EN ISO 22442-1:2021-08

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020.
01/08/2021
Active
Most Recent
DIN EN ISO 22442-1:2018-09

DIN EN ISO 22442-1:2018-09

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2018); German and English version prEN ISO 22442-1:2018
01/09/2018
Superseded
Historical
DIN EN ISO 22442-1:2016-05

DIN EN ISO 22442-1:2016-05

Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application de la gestion des risques (ISO 22442-1:2015); Version allemande EN ISO 22442-1:2015
01/05/2016
Superseded
Historical
DIN EN ISO 22442-1:2015-08

DIN EN ISO 22442-1:2015-08

Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application de la gestion des risques (ISO/FDIS 22442-1:2015); Version allemande et anglaise FprEN ISO 22442-1:2015
01/08/2015
Superseded
Historical
DIN EN ISO 22442-1:2008-03

DIN EN ISO 22442-1:2008-03

Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application de la gestion des risques (ISO 22442-1:2007); Version allemande EN ISO 22442-1:2007
01/03/2008
Superseded
Historical
DIN EN ISO 22442-1:2006-09

DIN EN ISO 22442-1:2006-09

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2006); German version prEN ISO 22442-1:2006
01/09/2006
Superseded
Historical
DIN EN ISO 22442-1:2005-10

DIN EN ISO 22442-1:2005-10

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO/DIS 22442-1:2005); German version prEN ISO 22442-1:2005
01/10/2005
Superseded
Historical
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