Recognized standard
F3320-18
FDA recognition 3-158 · ASTM · Cardiovascular
Key facts
| Recognition number | 3-158 |
|---|---|
| Designation | F3320-18 |
| Title | Standard Guide forCoating Characterization of Drug Coated Balloons |
| Standards developer | ASTM International |
| Specialty area | Cardiovascular |
| Date of entry | Jan 14, 2019 |
| Device classes | Class 3 |
| Scope (excerpt) | 1.1 This guide describes recommended acute in-vitro characterization methods for drug coated balloon (DCB) coatings. These methods include: coating integrity, coating thickness, drug coating uniformity, and released particulates. Specifically, this guide details: 1.1.1 Characterization of integrity… |
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: