1、Designation:F332018Standard Guide forCoating Characterization of Drug Coated Balloons1This standard is issued under the fixed designation F3320;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in par
2、entheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide describes recommended acute in-vitro char-acterization methods for drug coated balloon(DCB)coatings.These methods include:coating integrity,c
3、oating thickness,drug coating uniformity,and released particulates.Specifically,this guide details:1.1.1 Characterization of integrity by inspection of thecoated balloon surface.1.1.2 Measurement of coating thickness.1.1.3 Quantitation of drug coating uniformity(uniformity ofdrug distribution over t
4、he balloon surface)longitudinally andcircumferentially.1.1.4 Quantitation of the number of particulates released,invarious size ranges,during simulated use testing(insertion,tracking,deployment,retraction,and withdrawal)along withchemical and crystallinity characterization of particulates.1.2 This d
5、ocument does not address:1.2.1 Mechanical testing of drug coated balloons(DCBs).1.2.2 Drug substance evaluation(e.g.,assay,relatedsubstances,uniformity of dosage units)of DCBs.1.2.3 Production release and stability testing,although somesections may be applicable in whole or in part.1.2.4 Standard an
6、alytical testing(e.g.,drug content,drugrelated substances,drug uniformity of dosage).1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 This standard does not purport to address all of thesafety concerns,if any,associated wi
7、th its use.It is theresponsibility of the user of this standard to establish appro-priate safety,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.5 This international standard was developed in accor-dance with internationally recognized pri
8、nciples on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2F2743 Guide for Coating Inspection
9、 and Acute ParticulateCharacterization of Coated Drug-Eluting Vascular StentSystems2.2 AAMI Standard:3AAMI TIR 42 Evaluation of Particulates Associated withVascular Medical Devices2.3 USP Standards:4USP Particulate Matter in InjectionsUSP Uniformity of Dosage Units3.Terminology3.1 Definitions:3.1.1
10、tracking,nnavigation of a guide wire,guide catheteror introducer sheath,and/or balloon system through actual orsimulated vascular anatomy.3.1.2 vascular model,na model that simulates or repli-cates the geometry of a clinically relevant,sufficiently chal-lenging anatomical vasculature for the intende
11、d anatomythrough which the system will be placed.There should be adeployment site within the model or mock vessel attached tothe model for balloon deployment.3.2 Definitions of Terms Specific to This Standard:3.2.1 acute,nthe timeframe including accessory and bal-loon delivery,deployment,and withdra
12、wal.3.2.2 background assessment,na test measuring thenumber/size of particulates within the Particulate test systemwithout accessories or test articles.3.2.3 drug coated balloon(DCB),nmedical device com-prised of a drug coating over the surface of vascular dilatationballoon.1This guide is under the
13、jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved June 1,2018.Published July 2018.DOI:10.1520/F332018.2For referenced ASTM standards,visit the ASTM website,www.as
14、tm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3Available from Association for the Advancement of Medical Instrumentation(AAMI),4301 N.Fairfax Dr.,Suite 301,Arlington,VA 222
15、03-1633,http:/www.aami.org.4Available from U.S.Pharmacopeial Convention(USP),12601 TwinbrookPkwy.,Rockville,MD 20852-1790,http:/www.usp.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accorda
16、nce with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 3.2.4 drug coating uniformity,na measure of drug distri-bution over the surface of the balloon intended to be coated.This evaluation is separate from uniformity of dosage units asdescribed in USP.3.2.5 expected segment content,nthe sum
