Recognized standard
F2477-07 (Reapproved 2013)
FDA recognition 3-87 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-87 |
|---|---|
| Designation | F2477-07 (Reapproved 2013) |
| Title | Standard Test Methods for in vitro Pulsatile Durability |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 3, HDE |
| Scope (excerpt) | These test methods cover the determination of the durability of a vascular stent by exposing it to physiologically relevant diametric distension levels by means of hydrodynamic pulsatile loading. This testing occurs on a stent test specimen that has been deployed into a mock (elastically simulated)… |
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: