ASTM_F_2394_-_07_2013.pdf

Designation:F239407(Reapproved 2013)Standard Guide forMeasuring Securement of Balloon Expandable VascularStent Mounted on Delivery System1This standard is issued under the fixed designation F2394;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 provides guidance for the design and devel-opment of pre-test treatments,tests,and test endpoints tomeasure stent securement of pre-mounted,unsheathed,balloon-expandable stent delivery systems.This guide is in-tended to aid investigators in the design,development,and invitro characterization of pre-mounted,unsheathed,balloon-expandable stent delivery systems.1.2 This guide covers the laboratory determination of theshear force required to displace or dislodge a balloon-expandable endovascular stent mounted on a delivery system.The guide proposes a set of options to consider when testingstent securement.The options cover pre-test treatments,pos-sible stent securement tests,and relevant test endpoints.Anexample test apparatus is given in 7.1.1.3 This guide covers in vitro bench testing characterizationonly.Measured levels of securement and product design/process differentiation may be particularly influenced by selec-tions of pre-test treatments,securement test type(for example,stent gripping method),and test endpoint.In vivo characteris-tics may also differ from in vitro results.1.4 This guide does not cover all possible pre-testtreatments,stent securement tests,or test endpoints.It isintended to provide a starting point from which to select andinvestigate securement test options.1.5 This guide does not specify a method for mounting thestent onto the delivery system.1.6 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the standard.1.7 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory requirements prior to use.2.Referenced Documents2.1 ASTM Standards:2E1169 Practice for Conducting Ruggedness TestsE1488 Guide for Statistical Procedures to Use in Developingand Applying Test Methods2.2 Other Documents:ISO 10555-1 Sterile Sterile Sterile,Single-use IntravascularCathetersPart 1:General Requirements3Quality System Regulation,Part VII Dept.Health and Hu-man Services,Food and Drug Administration,21 CFRPart 820 Medical Devices;Current Good ManufacturingPractice;Final Rule.Federal Register,October 7,19964EN 14299 Non Active Surgical ImplantsParticular Re-quirements for Cardiac and Vascular ImplantsSpecificRequirements For Arterial Stents,May 20045CDRH Guidance,Non-Clinical Tests and RecommendedLabeling for Intravascular Stents and Associated DeliverySystems,January 13,20056MAUDE Database73.Terminology3.1 Definitions:3.1.1 balloon expandable stent,na stent that is expandedat the treatment site by a balloon catheter.The stent material is1This 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 March 1,2013.Published March 2013.Originallyapproved in 2004.Last previous edition approved in 2007 as F2394 07.DOI:10.1520/F2394-07R13.2For referenced ASTM standards,visit the ASTM website,www.astm.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 American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.4Available from U.S.Government Printing Office Superintendent of Documents,732 N.Capitol St.,NW,Mail Stop:SDE,Washington,DC 20401,http:/www.access.gpo.gov.5Available from British Standards Institute(BSI),389 Chiswick High Rd.,London W4 4AL,U.K.,http:/www.bsi-.6Available from Food and Drug Administration(FDA),5600 Fishers Ln.,Rockville,MD 20857,.Http:/www.fda.gov/cdrh/ode/guidance/1545.pdf.7Http:/www.fda.gov/cdrh/maude.html.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 plastically deformed by the balloon expansion such that thestent remains expanded after deflation of the balloon.3.1.2 crimp,vto secure the stent on the delivery system byradially compressing and plastically deforming the stent ontothe balloon.3.1.3 delivery system,na system similar to a balloondilatation catheter that is used to deli