Recognized standard
13779-4 Second edition 2018-12
FDA recognition 8-516 · ISO · Materials
Key facts
| Recognition number | 8-516 |
|---|---|
| Designation | 13779-4 Second edition 2018-12 |
| Title | Implants for surgery - Hydroxyapatite - Part 4: Determination of coating adhesion strength |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies a test method for measurement of the adhesion strength of hydroxyapatite coatings intended for use on metallic-substrate components of surgical implants. NOTE Requirements for the competence of testing laboratories can be found in ISO/IEC 17025. |
At a glance
- 10–99 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: