DIN EN ISO 22442-1:2016-05
Superseded Standard
Historical

DIN EN ISO 22442-1:2016-05

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version EN ISO 22442-1:2015
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

À remplacer par DIN EN ISO 22442-1 (2018-09).

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 05/01/2016
Page Count 43
EAN ---
ISBN ---
Weight (in grams) ---
No products.

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

Dispositifs médicaux utilisant des tissus animaux et leurs dérivés - Partie 1: Application de la gestion des risques (ISO/DIS 22442-1:2018); Version allemande et anglaise prEN ISO 22442-1:2018
01/09/2018
Superseded
Historical
DIN EN ISO 22442-1:2016-05

DIN EN ISO 22442-1:2016-05

Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015); German version 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Superseded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Superseded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Superseded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
Contact us