Recognized standard
F1820-22
FDA recognition 11-394 · ASTM · Orthopedic
Key facts
| Recognition number | 11-394 |
|---|---|
| Designation | F1820-22 |
| Title | Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 19, 2022 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | 1.1 This test method covers a standard methodology by which to measure the attachment strength between the modular acetabular shell and liner. Although the methodology described does not replicate physiological loading conditions, it has been described as a means of comparing the integrity of… |
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: