ASTM_F_2081_-_06_2017.pdf

Designation:F208106(Reapproved 2017)Standard Guide forCharacterization and Presentation of the DimensionalAttributes of Vascular Stents1This standard is issued under the fixed designation F2081;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 covers the identification of and recom-mended measurement methods for those dimensional attributesof vascular stents that are deemed relevant to successfulclinical performance.The delivery system packaged with andlabeled specifically for use during the placement of the stent isalso included within the scope of this guide.1.2 This guide addresses only the dimensional characteris-tics of stents.Material property and stent functional character-istics are not addressed herein.All dimensional characteristicsdescribed in this guide refer to in vitro(“bench-top”)charac-terization.Because of variable patient factors,for example,vessel compliance,the actual in vivo characteristics may beslightly different.1.3 This guide includes recommendations generally appli-cable to balloon-expandable and self-expanding stents fabri-cated from metals and metal alloys.It does not specificallyaddress any attributes unique to coated stents or polymeric orbiodegradable stents,although the application of this guide tothose products is not precluded.1.4 While they are not specifically included within the scopeof this guide,stents indicated for placement in nonvascularlocations,such as the esophagus or bile duct,also might becharacterized by the methods contained herein.Likewise,thisguide does not include recommendations for endovasculargrafts(“stent-grafts”)or other conduit devices commonly usedto treat aneurysmal disease or peripheral vessel trauma or toprovide vascular access,although some information includedherein may be applicable to those devices.1.5 This guide does not include recommendations for bal-loon catheters sold as stand-alone angioplasty catheters,eventhough some of those catheters may be used for the delivery ofunmounted stents supplied without a delivery system.Require-ments for angioplasty catheters are contained in standards ISO10555-1 and ISO 10555-4.1.6 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.1.6.1 The units of measurements used throughout this guidereflect the hybrid system in common clinical use in the UnitedStates as of the time of the original approval of this guide.Since a primary purpose of this guide is to promote uniformityof labeling to facilitate the selection of devices by clinicalusers,the units most preferred by users were selected for thisguide.Where those units are not SI units,or derivativesthereof,SI units are provided in parentheses.1.7 This international standard was developed in accor-dance with internationally recognized principles 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 ISO Standards:ISO 10555-1,Sterile,Single-Use Intravascular Catheters,General Requirements2ISO 10555-4,Sterile,Single-Use Intravascular CathetersBalloon Dilation Catheters23.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 balloon-expandable stent,na stent that is expandedat the treatment site by a balloon catheter.The stent is alteredpermanently by the balloon expansion such that the stentremains expanded after deflation of the balloon.3.1.2 bridge,na connecting element between the radialsupport aspects of a stent.A bridge may have unique designfeatures,as compared to a strut,to enhance longitudinalflexibility and minimize shortening.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devicesand is the direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved Sept.1,2017.Published September 2017.Originallyapproved in 2001.Last previous edition approved in 2013 as F2081 06(2013).DOI:10.1520/F2081-06R17.2Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the