Recognized standard
F2514-21
FDA recognition 3-171 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-171 |
|---|---|
| Designation | F2514-21 |
| Title | Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Dec 20, 2021 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 Purpose-This guide establishes recommendations and considerations for the development, verification, validation, and reporting of structural finite element models used in the evaluation of the performance of a metallic vascular stent design undergoing uniform radial loading. This standard guide… |
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: