Recognized standard
14243-3 Second edition 2014-11-01
FDA recognition 11-367 · ISO · Orthopedic
Key facts
| Recognition number | 11-367 |
|---|---|
| Designation | 14243-3 Second edition 2014-11-01 |
| Title | Implants for surgery - Wear of total knee-joint prostheses - Part 3: Loading and displacement parameters for wear-testing machines with displacement control and corresponding environmental conditions for test [Including AMENDMENT1 (2020)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jul 6, 2020 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This part of ISO 14243 describes a test method that specifies flexion/extension 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 wear testing of total knee-joint… |
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: