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ISO 10993-3

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

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Organization: ISO
Publication Date: 1 October 2014
Status: active
Page Count: 42
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

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.

NOTE Guidance on selection of tests is provided in ISO 10993-1.

Document History

ISO 10993-3
October 1, 2014
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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...
October 15, 2003
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
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...
January 1, 1992
Biological Evaluation of Medical Devices - Part 3: Tests for Genotoxicity, Carcinogenicity, and Reproductive Toxicity; (CEN EN 30993-3: 1993)
A description is not available for this item.

References

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