Recognized standard
F603-12 (Reapproved 2020)
FDA recognition 8-226 · ASTM · Materials
Key facts
| Recognition number | 8-226 |
|---|---|
| Designation | F603-12 (Reapproved 2020) |
| Title | Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
| Standards developer | ASTM International |
| Specialty area | Materials |
| Date of entry | Aug 21, 2017 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | 1.1 This specification covers the material requirements for high-purity, dense aluminum oxide for load-bearing surgical implant applications. 1.2 This specification does not cover finished parts (for example, femoral heads, acetabular inserts, dental implants and the like). It is intended as a… |
At a glance
- 1–9 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: