Recognized standard
14242-4 First edition 2018-05
FDA recognition 11-358 · ISO · Orthopedic
Key facts
| Recognition number | 11-358 |
|---|---|
| Designation | 14242-4 First edition 2018-05 |
| Title | Implants for surgery - Wear of total hip-joint prostheses - Part 4: Testing hip prostheses under variations in component positioning which results in direct edge loading |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 3, Class 2 |
| Scope (excerpt) | This document specifies the test conditions to simulate edge loading in hip prostheses due to steep acetabular cup inclination angle and dynamic separation conditions. This document is used in conjunction with ISO 14242-1 or ISO 14242-3. |
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: