Recognized standard
13179-1 Second Edition 2021-09
FDA recognition 8-577 · ISO · Materials
Key facts
| Recognition number | 8-577 |
|---|---|
| Designation | 13179-1 Second Edition 2021-09 |
| Title | Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
| Standards developer | International Organization for Standardization |
| Specialty area | Materials |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 2 |
| Scope (excerpt) | This part of ISO 13179 specifies general requirements for plasma-sprayed unalloyed titanium coatings on metallic surgical implants. This document applies to atmospheric plasma spraying and vacuum plasma spraying. This document does not apply to coatings made of other materials than titanium or… |
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: