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Norm
ÖNORM EN ISO 10993-3
Issue date: 2015 01 01
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests
and risk management, with respect to the possibility of the fol...
Valid
Publisher:
Austrian Standards International
Format:
Digital | 45 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests
and risk management, with respect to the possibility of the following potentially irreversible biological
effects arising as a result of exposure to medical devices:
— genotoxicity;
— carcinogenicity;
— 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.
ÖNORM EN ISO 10993-3
2015 01 01
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and repro...
Norm
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ÖNORM EN ISO 10993-3
2009 08 15
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and repro...
Norm
ÖNORM EN ISO 10993-3
2004 02 01
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and repro...
Norm
ÖNORM EN 30993-3
1994 05 01
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and repro...
Norm
Norm
Issue date :
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2007 04 04
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
Draft
Issue date :
2014 10 16
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
Norm
Issue date :
2012 06 29
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
Norm
Issue date :
2005 06 30
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
Norm
Issue date :
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
Issue date :
2006 07 06
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
2020 01 13
Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process
Norm
Issue date :
2014 09 24
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
