Recognized standard
F2582-20
FDA recognition 11-381 · ASTM · Orthopedic
Key facts
| Recognition number | 11-381 |
|---|---|
| Designation | F2582-20 |
| Title | Standard Test Method for Dynamic Impingement Between Femoral and Acetabular Hip Components |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jun 7, 2021 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This test method covers a procedure to simulate dynamic impingement between femoral and acetabular components in a hip replacement; the subsequent qualitative assessment of damage modes (as outlined in 8.2); and, if necessary, quantitative assessment of changes in modular component attachment… |
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: