Recognized standard
11491 First edition 2017-07
FDA recognition 11-338 · ISO · Orthopedic
Key facts
| Recognition number | 11-338 |
|---|---|
| Designation | 11491 First edition 2017-07 |
| Title | Implants for surgery - Determination of impact resistance of ceramic femoral heads for hip joint prostheses |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Sep 17, 2018 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document specifies two alternative test methods for determining the impact resistance of ceramic femoral heads for hip joint prostheses. |
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: