ANSI/AAMI/ISO 10993-3:2014(R2023)
Current
The latest, up-to-date edition.
Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
Hardcopy , PDF
English
09-10-2023
Important note : All end users must be registered with an Account prior to user licenses being assigned.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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