Recognized standard
F2554-22
FDA recognition 11-415 · ASTM · Orthopedic
Key facts
| Recognition number | 11-415 |
|---|---|
| Designation | F2554-22 |
| Title | Standard Practice for Measurement of Positional Accuracy of Computer-Assisted Surgical Systems |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Dec 23, 2024 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This document provides procedures for measurement and reporting of basic static performance of surgical navigation and/or robotic positioning devices under defined conditions. They can be performed on a subsystem (for example, tracking only) or a full computer-aided surgery system as would be… |
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: