1、Designation:F303613Standard Guide forTesting Absorbable Stents1This standard is issued under the fixed designation F3036;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
2、year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This Guide covers select physical and mechanical char-acterizations of vascular stents with one or more absorbablecomponents.Such absorbable stents(also referred to as vas-cul
3、ar scaffolds)are used to provide temporary luminal supportof the coronary and peripheral vasculature following interven-tional revascularization procedures.This Guide covers devicesthat are fabricated from one or more degradable polymersand/or metals(from this point on referred to as“absorbable”).Th
4、is Guide provides a framework for evaluating the change inselect physical and mechanical characteristics of absorbablestents from manufacture through their intended degradation invivo.Specific testing recommendations are limited to existingASTM standards for stent evaluation.1.2 Recommendations spec
5、ific to non-absorbable stentswith absorbable coatings are not within scope.1.3 Recommendations specific to testing absorbable stentgrafts are not provided here,however this standard has manyelements applicable to testing absorbable stent grafts.1.4 Clinical need dictates that absorbable stents initi
6、allypossess the same general dimensions and mechanical functionas their non-absorbable counterparts.Thus,utilization of al-ready established mechanical stent evaluation methods ispossible when absorbable test specimens are previously con-ditioned under physiologically relevant temperature and hu-mid
7、ity.As a result,this standard addresses absorbable-specifictesting issues related to the mechanical and physical evaluationof these devices.This standard is limited to providingabsorbable-specific testing recommendations for evaluationswhere an ASTM method for durable(i.e.,non-absorbable)stents is a
8、lready available.Specifically,this standard providestesting recommendations for adapting the elastic recoil(ASTMF2079),securement/dislodgement(ASTM F2394),and three-point bending(ASTM F2606)tests to fully absorbable devices.This guide generally describes specimen conditioning,asappropriate,for absor
9、bable devices,which can range fromnone to extensive depending on the measured attribute andrelevant clinical exposure conditions,including time in thein-use environment.There are additional stent evaluationmethods that are not addressed explicitly in this guide,e.g.,chronic durability,that may requi
10、re absorbable-specific provi-sions.The user should justify the appropriate testing for thespecific polymer and device.1.4.1 While the primary purpose of this guide is to addressabsorbable stent-related issues specific to the tests described inSection 1.3,additional testing(e.g.,radial strength)will
11、likelyalso be needed.Thus,aspects of what is presented herein maybe applicable to additional relevant device attributes,such asthose described in ISO 25539-1 and/or 25539-2.1.5 This Guide may not be appropriate for all absorbabledevices,for example those that possess limited hydrolytic orcorrosion s
12、usceptibility and degrade in vivo primarily throughenzymatic action.The user is cautioned to consider theappropriateness of the standard in view of the particularabsorbable device and its potential application.1.6 This Guide does not address the methods necessary tocharacterize the chemical degradat
13、ion of the absorbable stent(e.g.,changes in mass,molecular weight,or degradants).However,this type of characterization does represent animportant component of the degradation profile and mecha-nism of the device.These characterizations are addressed inASTM F1635.1.7 The values stated in SI units are
14、 to be regarded asstandard.No other units of measurement are included in thisstandard.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
15、determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D618 Practice for Conditioning Plastics for TestingE6 Terminology Relating to Methods of Mechanical Testing1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surg
16、ical Materials and Devices and is the direct responsibility of SubcommitteeF04.30 on Cardiovascular Standards.Current edition approved Nov.1,2013.Published December 2013.DOI:10.1520/F3036-13.2For 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 Conshoh