1.1This 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:
1.1.1Characterization of integrity by inspection of the coated balloon surface.
1.1.2Measurement of coating thickness.
1.1.3Quantitation of drug coating uniformity (uniformity of drug distribution over the balloon surface) longitudinally and circumferentially.
1.1.4Quantitation of the number of particulates released, in various size ranges, during simulated use testing (insertion, tracking, deployment, retraction, and withdrawal) along with chemical and crystallinity characterization of particulates.
1.2This document does not address:
1.2.1Mechanical testing of drug coated balloons (DCBs).
1.2.2Drug substance evaluation (e.g., assay, related substances, uniformity of dosage units) of DCBs.
1.2.3Production release and stability testing, although some sections may be applicable in whole or in part.
1.2.4Standard analytical testing (e.g., drug content, drug related substances, drug uniformity of dosage).
1.3The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
1.5This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.