Recognized standard
F3047M-23
FDA recognition 11-403 · ASTM · Orthopedic
Key facts
| Recognition number | 11-403 |
|---|---|
| Designation | F3047M-23 |
| Title | Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 18, 2023 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device… |
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: