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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 by inspection of the coated balloon surface.
| Author | ASTM |
|---|---|
| Editor | ASTM |
| Document type | Standard |
| Format | File |
| ICS | 11.040.99 : Other medical equipment |
| Number of pages | 12 |
| Set | ASTMVOL1302 |
| Year | 2018 |
| Country | USA |
| Keyword | ASTM 3320;ASTM F3320;ASTM F3320;10.1520/F3320-18 |