ASTM_F_2743_-_11.pdf

Designation:F274311Standard Guide forCoating Inspection and Acute Particulate Characterization ofCoated Drug-Eluting Vascular Stent Systems1This standard is issued under the fixed designation F2743;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 parentheses 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 in vitro test proce-dures for coating inspection and acute particulate characteriza-tion of coated drug-eluting vascular(balloon-expandable andself-expanding)stent systems.1.2 Recommended practices for coating inspection andacute particulate characterization include baseline(deploy-ment)testing and simulated use testing.This guide describesthe capture and analysis of particulates.This guide describesthe inspection of the coated stent surface.This guide wasdeveloped for characterization and not intended for productionrelease testing of coated drug-eluting vascular stent systemsalthough some sections may be appropriate.1.3 Chronic particulate characterization and coating inspec-tion are not included herein.1.4 Coating systems specifically designed to degrade orotherwise intentionally separate themselves from the perma-nent stent structure may not be fully addressed herein.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 The values stated in inch-pound units are to be regardedas standard.The values given in parentheses are mathematicalconversions to SI units that are provided for information onlyand are not considered standard.2.Referenced Documents2.1 Other Standards:USP Particulate Matter in Injections2FDA Guidance for Industry and FDA Staff Non-ClinicalEngineering Tests and Recommended Labeling for Intra-vascular Stents and Associated Delivery Systems,April18,20103AAMI TIR42:2010 Evaluation of Particulates Associatedwith Vascular Medical Devices43.Terminology3.1 Definitions:3.1.1 mock vesselphysical simulation of the vasculature atthe intended clinical deployment site.3.1.2 stent systema system comprised of a vascular stentand its delivery system.3.1.3 trackingnavigation of a guide wire,guide catheter,and/or stent system through either actual or simulated vascularanatomy.3.1.4 tracking fixturea model that simulates or replicatesthe geometry of a representative vasculature through which thestent system will be passed.3.2 Definitions of Terms Specific to This Standard:3.2.1 acutea test timeframe intended to include stentdelivery and deployment beginning with the initial insertion ofstent system until full removal of the delivery system and itsaccessory devices.3.2.2 baselinecoating inspection and acute particulatecharacterization after stent expansion to the desired diameter inan unconstrained environment and without tracking.3.2.3 chronica test timeframe intended to mimic theimplantation time after full removal of the delivery system andits accessory devices.3.2.4 constrained environmenta deployment site in whichthe stent is deployed into a mock vessel.3.2.5 simulated usecoating inspection and acute particu-late characterization after tracking in simulated anatomy andaqueous environment.It may also include deployment in bentconfiguration,deployment in overlapped configuration,post-dilatation,or other scenarios that can reasonably be expected inclinical use.1This guide is under the 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 Oct.1,2011.Published November 2011.DOI:10.1520/F2743-11.2Available from U.S.Pharmacopeia(USP),12601 Twinbrook Pkwy.,Rockville,MD 20852-1790,http:/www.usp.org.3Available from Food and Drug Administration(FDA),10903 New HampshireAve.,Silver Spring,MD 20993-0002,http:/www.fda.gov.4Available from Association for the Advancement of Medical Instrumentation(AAMI),4301 North Fairfax Dr.,Suite 301,Arlington,VA 22203-1633.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.6 unconstrained environmenta deployment site inwhich the stent is not constrained by a mock vessel.Compareto“Constrained Environment”.4.Summary of Practice4.1 Test Sequence and SamplesBaseline and SimulatedUse Testing are conducted as two separate tests.Coatinginspection and acute particulate characterization may be per-formed as two separate tests with independent samples.4.2 Baseline TestingA single stent is deployed to nominalor maximum labeled diameter.The stent is expanded in anunconstrained environment so as to characterize the stent only.Baseline testing includes coating inspection and acute particu-late characterization of the stent.Baseline coating inspectionmay be conducted after deployment in air or in an aqueousunc