Recognized standard
F897-19
FDA recognition 11-363 · ASTM · Orthopedic
Key facts
| Recognition number | 11-363 |
|---|---|
| Designation | F897-19 |
| Title | Standard Test Method for Measuring Fretting Corrosion of Osteosynthesis Plates and Screws |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This test method provides a screening test for determining the amount of metal loss from plates and screws used for osteosynthesis (internal fixation of broken bones) due to fretting corrosion in the contact area between the screw head and the plate hole countersink area. The implants are used… |
At a glance
- 1–9 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: