Recognized standard
F1875-98 (Reapproved 2022)
FDA recognition 11-183 · ASTM · Orthopedic
Key facts
| Recognition number | 11-183 |
|---|---|
| Designation | F1875-98 (Reapproved 2022) |
| Title | Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Aug 14, 2015 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This practice describes the testing, analytical, and characterization methods for evaluating the mechanical stability of the bore and cone interface of the head and stem junction of modular hip implants subjected to cyclic loading by measurements of fretting corrosion (1-5). Two test methods… |
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: