Recognized standard
F3143-20
FDA recognition 11-383 · ASTM · Orthopedic
Key facts
| Recognition number | 11-383 |
|---|---|
| Designation | F3143-20 |
| Title | Standard Test Method for Determination of Frictional Torque and Friction Factor for Hip Replacement Bearings under Standard Conditions Using a Reciprocal Friction Simulator |
| 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 procedure provides a method of determining the frictional torque and friction factor of artificial hip joint bearings used in total hip replacement (THR) systems under laboratory conditions using a reciprocal friction simulator. This test method specifies the angular movement between… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
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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: