Recognized standard
7206-6 Second edition 2013-11-15
FDA recognition 11-277 · ISO · Orthopedic
Key facts
| Recognition number | 11-277 |
|---|---|
| Designation | 7206-6 Second edition 2013-11-15 |
| Title | Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jul 9, 2014 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 7206 specifies test methods and the fatigue performance for the endurance properties, under specified laboratory conditions, of neck region of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement. This… |
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: