Recognized standard
F3107-14
FDA recognition 11-304 · ASTM · Orthopedic
Key facts
| Recognition number | 11-304 |
|---|---|
| Designation | F3107-14 |
| Title | Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | 1.1 This standard will measure the effects on the accuracy of computer assisted surgery (CAS) systems of the environmental influences caused by equipment utilized for bone preparation during the intended clinical application for the system. The environmental vibration effect covered in this standard… |
At a glance
- None 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: