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sklademVydáno: 2015-03-31
PD ISO/TR 10993-33:2015
Biological evaluation of medical devices Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
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| Označení normy: | PD ISO/TR 10993-33:2015 |
| Počet stran: | 60 |
| Vydáno: | 2015-03-31 |
| ISBN: | 978 0 580 84781 3 |
| Status: | Standard |
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PD ISO/TR 10993-33:2015
This standard PD ISO/TR 10993-33:2015 Biological evaluation of medical devices is classified in these ICS categories:
- 11.100.20 Biological evaluation of medical devices
There are differences between the views of regulatory bodies on the subject of genotoxicity testing. The purpose of this Technical Report is to provide background information to facilitate the selection of tests and guidance on the performance of tests.