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Standard Guide for Coating Characterization of Drug-Coated Balloons
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.
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 Quantitation 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.
1.2 This document does not address:
1.2.1 Mechanical testing of drug-coated balloons (DCBs).
1.2.2 Drug substance evaluation (e.g., assay, related substances, uniformity of dosage units) of DCBs.
1.2.3 Production release and stability testing, although some sections may be applicable in whole or in part.
1.2.4 Standard analytical testing (e.g., drug content, drug related substances, drug uniformity of dosage).
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 This 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.
1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International StandardDetails, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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