Recognized standard
14242-2 Second edition 2016-09-15
FDA recognition 11-314 · ISO · Orthopedic
Key facts
| Recognition number | 11-314 |
|---|---|
| Designation | 14242-2 Second edition 2016-09-15 |
| Title | Implants for surgery - Wear of total hip-joint prostheses - Part 2: Methods of measurement |
| 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 14242 specifies methods of assessment of wear of the acetabular component of total hip-joint prostheses using gravimetric techniques and changes in dimensional form of components tested in accordance with ISO 14242-1 or ISO 14242-3 as appropriate. NOTE Some investigators have… |
At a glance
- 10–99 Product codes
- 1–9 FDA guidance documents
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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: