Recognized standard
F3495-23
FDA recognition 11-409 · ASTM · Orthopedic
Key facts
| Recognition number | 11-409 |
|---|---|
| Designation | F3495-23 |
| Title | Standard Test Methods for Determining the Static Failure Load of Ceramic Knee Femoral Components |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 18, 2023 |
| Scope (excerpt) | 1.1 The test methods included in this standard cover two procedures for static burst testing of a ceramic femoral component used in total knee replacement (TKR). The two procedures are used to determine the static ultimate failure load of a ceramic femoral knee component. Both procedures are… |
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: