CEN - EN ISO 10993-3
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
active, Most Current
| Organization: | CEN |
| Publication Date: | 1 October 2014 |
| Status: | active |
| Page Count: | 48 |
| 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 testsand risk management, with respect to the possibility of the following potentially irreversible biologicaleffects 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,carcino
NOTE Guidance on selection of tests is provided in ISO 10993-1.
Document History
EN 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 testsand risk management, with respect to the possibility of the following potentially irreversible...
May 1, 2009
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...
October 31, 2003
Biological evaluation of medical devices Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
A description is not available for this item.