Recognized standard
7206-4 Third edition 2010-06-15
FDA recognition 11-312 · ISO · Orthopedic
Key facts
| Recognition number | 11-312 |
|---|---|
| Designation | 7206-4 Third edition 2010-06-15 |
| Title | Implants for surgery - Partial and total hip joint prostheses - Part 4: Determination of endurance properties and performance of stemmed femoral components [Including AMENDMENT 1 (2016)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Dec 23, 2016 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 7206 specifies a test method for determining the endurance properties of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joints under specified laboratory conditions. It also defines the conditions of testing so that… |
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: