Recognized standard
10993-5 Third edition 2009-06-01 10993-5:2009/(R)2014
FDA recognition 2-245 · ISO · Biocompatibility
Key facts
| Recognition number | 2-245 |
|---|---|
| Designation | 10993-5 Third edition 2009-06-01 10993-5:2009/(R)2014 |
| Title | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Dec 23, 2016 |
| Scope (excerpt) | This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion. These methods are designed to determine the… |
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: