1.1 This guide describes recommended acute, in-vitro, general procedures for characterization of drug-coated balloons (DCB). These methods include: coating integrity, coating thickness, drug coating uniformity, and released particulates. 1.2 This guide provides recommended practices for coating integrity inspection, coating thickness, drug coating uniformity, and particulate testing including the: 1.2.1 Evaluation of integrity by visual inspection of the coated balloon surface; 1.2.2 Measurement of coating thickness; 1.2.3 Quantitation of the balloon surface for drug coating uniformity length (longitudinally) and circumferentially; and 1.2.4 Released particulate quantitation along with chemical and crystallinity characterization of particles following simulated use (tracking and deployment). 1.3 Chronic characterization and inspection are not included herein. 1.4 Infusion or weeping devices are not addressed herein. 1.5 Units--The values stated in SI units are to be regarded as the standard. No other units of measurement are included in this standard.
Provide consensus for the acute evaluation of durability for drug-coated balloons.
Keywordscoating inspection; drug coating uniformity; drug-coated balloon; DCB; particulate; particulate characterization; simulated use
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
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