Recognized standard
10993-6 Third edition 2016-12-01
FDA recognition 2-247 · ISO · Biocompatibility
Key facts
| Recognition number | 2-247 |
|---|---|
| Designation | 10993-6 Third edition 2016-12-01 |
| Title | Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation |
| Standards developer | International Organization for Standardization |
| Specialty area | Biocompatibility |
| Date of entry | Aug 21, 2017 |
| Scope (excerpt) | This part of ISO 10993 specifies test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices. This part of ISO 10993 applies to materials that are - solid and non-absorbable, - non-solid, such as porous materials, liquids, gels, pastes… |
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: