DIN EN ISO 10993-3:2015-02
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DIN EN ISO 10993-3:2015-02

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
Most recent standard

Summary

This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: - genotoxicity, - carcinogenicity and - reproductive and developmental toxicity. This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

Technical characteristics

Publisher Deutsche Institut für Normung e.V. (DIN)
Publication Date 02/01/2015
Page Count 48
EAN ---
ISBN ---
Weight (in grams) ---
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Previous versions

DIN EN ISO 10993-3:2025-05

DIN EN ISO 10993-3:2025-05

Biological evaluation of medical devices - Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity (ISO/DIS 10993-3:2025); German and English version prEN ISO 10993-3:2025
01/05/2025
Active
Most Recent
DIN EN ISO 10993-3:2015-02

DIN EN ISO 10993-3:2015-02

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014); German version EN ISO 10993-3:2014
01/02/2015
Active
Most Recent
DIN EN ISO 10993-3:2013-03

DIN EN ISO 10993-3:2013-03

Évaluation biologique des dispositifs médicaux - Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction (ISO/DIS 10993-3:2013); Version allemande prEN ISO 10993-3:2013
01/03/2013
Superseded
Historical
DIN EN ISO 10993-3:2011-08

DIN EN ISO 10993-3:2011-08

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO/DIS 10993-3:2011); German version prEN ISO 10993-3:2011
01/08/2011
Superseded
Historical
DIN EN ISO 10993-3:2009-08

DIN EN ISO 10993-3:2009-08

Évaluation biologique des dispositifs médicaux - Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction (ISO 10993-3:2003); Version allemande EN ISO 10993-3:2009
01/08/2009
Superseded
Historical
DIN EN ISO 10993-3/A1:2009-02

DIN EN ISO 10993-3/A1:2009-02

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003); English version prEN ISO 10993-3:2008, Amendment 1
01/02/2009
Superseded
Historical
DIN EN ISO 10993-3:2004-02

DIN EN ISO 10993-3:2004-02

Évaluation biologique des dispositifs médicaux - Partie 3: Essais concernant la génotoxicité, la cancérogénicité et la toxicité sur la reproduction (ISO 10993-3:2003); Version allemande EN ISO 10993-3:2003
01/02/2004
Superseded
Historical
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