ASTM_F_2942_-_13.pdf

Designation:F294213Standard Guide forin vitro Axial,Bending,and Torsional Durability Testing ofVascular Stents1This standard is issued under the fixed designation F2942;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 includes three separate cyclic deformationdurability guides related to vascular stents:bending,axial,andtorsional.1.2 This guide does not address flat plate,local crushdurability,or multi-mode testing.1.3 This guide applies to balloon-expandable and self-expanding stents fabricated from metals and metal alloys.Itdoes not specifically address any attributes unique to coatedstents(i.e.,stent with a surface layer of an additionalmaterial(s),monolithically polymeric stents,or absorbablestents,although the application of this standard to thoseproducts is not precluded.1.4 This guide is applicable to testing of stent(s)(or arepresentative portion of a stent).While durability testing ofcoupon samples(e.g.,a scaled-up portion of the stent structure)can provide useful information,it is not within the scope of thisguide.1.5 This guide applies to endovascular grafts(“stent-grafts”)and other conduit products commonly used to treataneurismal disease,peripheral vessel trauma,or to providevascular access.The information provided herein does notaddress all issues related to testing of these devices.1.6 This guide applies to in vitro modeling of stent durabil-ity from non-radial arterial motions.Such motions may arisefrom musculoskeletal activities,including walking andbreathing,and cardiac motion.ASTM F2477 addresses pulsa-tile(i.e.,radial)durability of vascular stents.1.7 This guide does not provide the in vivo physiologicdeformation conditions for a vascular stent.It is incumbentupon the user of the standard to develop and justify theseboundary conditions(e.g.,literature review,in vivo studies,cadaver studies,or modeling of stent vessel interaction)inthese durability bench tests.Additional conditions that may beconsidered include vessel calcification,vessel taper,eccentriclesions,loading excursions(e.g.,exercise),and vessel remod-eling.1.8 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 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F2477 Test Methods forin vitro Pulsatile Durability Testingof Vascular Stents2.2 Other Documents:ASTM STP 588 Manual on Statistical Planning andAnalysis,R.E.Little,1975ISO 25539 Cardiovascular ImplantsEndovascular Device-sPart 2:Vascular StentsFDAGuidance Document#1545“Non-Clinical EngineeringTests and Recommended Labeling for Intravascular StentsandAssociated Delivery Systems”(IssuedApril 18,2010)3.Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 axial,adjcompression or tension of a stent and/ormock vessel along its longitudinal axis.3.1.2 bending,adjdeformation on the longitudinal axis ofa stent and/or mock vessel to achieve a specified stent radius ofcurvature.3.1.3 fracture,nthe complete separation of a stent struc-tural feature.3.1.4 mock vessel,na simulated vessel typically manufac-tured from an elastomeric material.3.1.5 radius of curvature,nthe inner,outer or centerlinebend radius of a stent.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved Aug.15,2013.Published September 2013.DOI:10.1520/F2942-13.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.6 specimen,narticle consisting of an implantable de-vice or a representative portion of an implantable device,thatis tested according to this guide.3.1.7 torsional,adjtwisting of a stent and/or mock vesselabout its longitudinal axis.4.Summary of Test Guides4.1 This guide covers in vitro durability testing of vascularstents using modes that represent those that might be observedin vivo such as bending,axial,or torsional deformation modes.Examples include,but are not limited to,the axial and bendingdeformation that occurs in the superficial femoral artery duringthe walking gait,the bending that occurs in the renal arteryduring respiration,and the bending that occurs in the coronaryartery during the cardiac cycle.This guide provides details andguidance for separate tests for