Recognized standard
F3211-17
FDA recognition 3-154 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-154 |
|---|---|
| Designation | F3211-17 |
| Title | Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Sep 17, 2018 |
| Scope (excerpt) | This guide is intended to provide an experimental methodology to assess and determine the structural fatigue life of implantable cardiovascular medical devices. This guide is also intended to provide methodologies to determine statistical bounds on fatigue life at in vivo use conditions using… |
At a glance
- None 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: