Recognized standard
10993-3 Third edition 2014-10-1 10993-3:2014
FDA recognition 2-228 · ISO · Biocompatibility
Key facts
| Recognition number | 2-228 |
|---|---|
| Designation | 10993-3 Third edition 2014-10-1 10993-3:2014 |
| Title | Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Jul 26, 2016 |
| Scope (excerpt) | 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: