DIN EN ISO 10993-3
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)
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| Organization: | DIN |
| Publication Date: | 1 February 2015 |
| Status: | active |
| Page Count: | 45 |
| 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 reporductive toxicity has been established.
NOTE Guidance on selection of tests is provided in ISO 10993-1.
Document History
DIN EN ISO 10993-3
February 1, 2015
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 following potentially...
August 1, 2009
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
A description is not available for this item.
February 1, 2009
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
A description is not available for this item.
February 1, 2004
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2003)
A description is not available for this item.