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Norm

ISO 10993-3:2014

Ausgabedatum: 2014 09 24

Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

ISO 10993-3:2014 specifies strategies for risk estimation, selection of hazard identification tests and risk management, with respect to the possibility of the following ...
Gültig
Herausgeber:
International Organization for Standardization
Format:
Digital | 34 Seiten
Sprache:
Englisch

ISO 10993-3:2014 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.

ISO 10993-3:2014 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, or reproductive toxicity has been established.

ISO 10993-3:2014
2014 09 24
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and repro...
Norm
ISO 10993-3:2003
2003 10 22
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and repro...
Norm
ISO 10993-3:1992
1992 12 30
Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and repro...
Norm