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.
Product Details
- Published:
- 06/01/2018
- Number of Pages:
- 12
- File Size:
- 1 file , 180 KB
