Recognized standard
13779-3 Second Edition 2018-12
FDA recognition 8-579 · ISO · Materials
Key facts
| Recognition number | 8-579 |
|---|---|
| Designation | 13779-3 Second Edition 2018-12 |
| Title | Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This document specifies methods of test for the chemical analysis, assessment of crystallinity ratio and phase composition of hydroxyapatite-based materials such as powders, coating or bulk products. NOTE These tests are intended to describe properties of the material and to communicate these… |
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: