ASTM-F3320 2024

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F3320-18(2024) Standard Guide for Coating Characterization of Drug-Coated Balloons

Published By	Publication Date	Number of Pages
ASTM	2024

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Categories: 11.040.99 - Other medical equipment, ASTM

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Description

ASTM F3320-18-Reapproved2024

Active Standard: Standard Guide for Coating Characterization of Drug-Coated Balloons

ASTM F3320

Scope

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 Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Keywords

coating inspection; DCB; drug-coated balloon; drug coating uniformity; particulate; particulate characterization; simulated use; vascular catheter;

ICS Code

ICS Number Code 11.040.99 (Other medical equipment)

DOI: 10.1520/F3320-18R24

Additional information

Standard Title	F3320-18(2024) Standard Guide for Coating Characterization of Drug-Coated Balloons
Published Code	ASTM
Publication Date	2024
ICS Codes	11.040.99 - Other medical equipment