Recognized standard
14243-2 Third edition 2016-09-01
FDA recognition 11-311 · ISO · Orthopedic
Key facts
| Recognition number | 11-311 |
|---|---|
| Designation | 14243-2 Third edition 2016-09-01 |
| Title | Implants for surgery - Wear of total knee-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, LXY, MBD |
| Scope (excerpt) | This part of ISO 14243 specifies a method of assessment of wear of the tibial component of total knee-joint prostheses using the gravimetric technique for components tested in accordance with ISO 14243-1 or ISO 14243-3 as appropriate. |
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: