Recognized standard
F2914-12 (Reapproved 2018)
FDA recognition 3-104 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-104 |
|---|---|
| Designation | F2914-12 (Reapproved 2018) |
| Title | Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Aug 20, 2012 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This guide addresses the determination of appropriate device attributes for testing as part of a shelf-life study for endovascular devices. Combination and biodegradable devices (for example drug-devices, biologic devices or drug biologics) may require additional considerations, depending on their… |
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: