Recognized standard
14242-3 First edition 2009-03-15
FDA recognition 11-349 · ISO · Orthopedic
Key facts
| Recognition number | 11-349 |
|---|---|
| Designation | 14242-3 First edition 2009-03-15 |
| Title | Implants for surgery - Wear of total hip-joint prostheses - Part 3: Loading and displacement parameters for orbital bearing type wear testing machines and corresponding environmental conditions for test [Including AMENDMENT 1 (2019)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 14242 specifies relative angular movement between articulating components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the orbital bearing type wear testing of total 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: