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Norm
ÖNORM EN ISO 10993-3
Issue date: 2009 08 15
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the
following biological aspects:
- genotoxicity,
- carcinogenic...
Withdrawn: 2015 01 01
§ Legal References
Publisher:
Austrian Standards International
Format:
Digital | 24 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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 for evaluation of a medical device whose potential for genotoxicity,
carcinogenicity or reproductive toxicity has been identified.
ÖNORM EN ISO 10993-3
2015 01 01
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and repro...
Norm
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 :
2003 10 22
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Norm
Issue date :
2005 06 30
Biological evaluation of medical devices — Part 18: Chemical characterization of materials
Norm
Issue date :
1997 12 11
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
Issue date :
1992 12 30
Biological evaluation of medical devices — Part 2: Animal welfare requirements
Norm
Issue date :
1994 07 07
Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
Norm
Issue date :
2002 12 11
Biological evaluation of medical devices — Part 12: Sample preparation and reference materials (Corrected version 2003-06)
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 :
2015 01 01
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
