1.1.This guide describes recommended acute in vitro characterization of drug coated balloon (DCB) coatings. These methods include: coating integrity, coating thickness, drug coating uniformity, and released particulates. Specifically this includes: 1.1.1.Characterization of integrity by inspection of the coated balloon surface. 1.1.2.Measurement of coating thickness. 1.1.3.Quantitation of drug coating uniformity (uniformity of drug distribution over the balloon surface) longitudinally and circumferentially. 1.1.4.Report the number of particulates released by size during simulated use testing (insertion, tracking, deployment, retraction, and removal) along with chemical and crystallinity characterization of particles. 1.2.This document will not address: 1.2.1.Mechanical testing of DCBs. 1.2.2.Lot release and stability testing. 1.2.3.Infusion or weeping devices. 1.3.The values stated in SI units are to be regarded as 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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