Recognized standard
14243-5 First edition 2019-05
FDA recognition 11-361 · ISO · Orthopedic
Key facts
| Recognition number | 11-361 |
|---|---|
| Designation | 14243-5 First edition 2019-05 |
| Title | Implants for surgery - Wear of total knee prostheses - Part 5: Durability performance of the patellofemoral joint |
| Standards developer | International Organization for Standardization |
| Specialty area | Orthopedic |
| Date of entry | Dec 23, 2019 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This document specifies the relative angular movement between articulating patellofemoral joint components, the pattern of the applied force, speed and duration of testing, sample configuration and test environment to be used for the durability testing of total knee-joint prostheses in wear-testing… |
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: