ANSI/AAMI/ISO 10993-3:2014(R2023)
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Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
Available format(s)
Hardcopy , PDF
Language(s)
English
Published date
09-10-2023
€234.70
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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.
| Committee |
ISO/TC 194
|
| DocumentType |
Standard
|
| Pages |
50
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| ISO 10993-3:2014 | Identical |
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