Recognized standard
13356:2015 Third Edition 2015-09-15
FDA recognition 8-430 · ISO · Materials
Key facts
| Recognition number | 8-430 |
|---|---|
| Designation | 13356:2015 Third Edition 2015-09-15 |
| Title | Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Jun 27, 2016 |
| Scope (excerpt) | This International Standard specifies the requirements and corresponding test methods for a biocompatible and biostable ceramic bone-substitute material based on yttria-stabilized tetragonal zirconia (yttria tetragonal zirconia polycrystal, Y-TZP) for use as a material for surgical implants. |
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: