ASTM F3320 – 18

The methods described herein allow for in-vitro characterization of DCB drug coating attributes that, along with pre-clinical and clinical safety and effectiveness data, establish that the DCBs, with the characterized coating attributes, are safe and effective. Clinical safety and therapeutic benefit may be affected by non-uniform distribution of the active pharmaceutical ingredient, coating anomalies on the device, and particulate release. Variability in drug coating may result in insufficient or excessive drug availability and inconsistent device performance.