Recognized standard
F3295-18
FDA recognition 11-354 · ASTM · Orthopedic
Key facts
| Recognition number | 11-354 |
|---|---|
| Designation | F3295-18 |
| Title | Standard Guide for Impingement Testing of Total Disc Prostheses |
| Standards developer | ASTM International |
| Specialty area | Orthopedic |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This standard is intended to provide guidance on the evaluation of wear and fatigue characteristics of total disc prostheses under cyclic impingement conditions. 1.2 This guide describes impingement testing of devices with articulating components. The user is cautioned that the methods described… |
At a glance
- 1–9 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: