ASTM_F_1717_-_15.pdf

Designation:F171715Standard Test Methods forSpinal Implant Constructs in a Vertebrectomy Model1This standard is issued under the fixed designation F1717;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 These test methods cover the materials and methods forthe static and fatigue testing of spinal implant assemblies in avertebrectomy model.The test materials for most combinationsof spinal implant components can be specific,depending on theintended spinal location and intended method of application tothe spine.1.2 These test methods are intended to provide a basis forthe mechanical comparison among past,present,and futurespinal implant assemblies.They allow comparison of spinalimplant constructs with different intended spinal locations andmethods of application to the spine.These test methods are notintended to define levels of performance,since sufficientknowledge is not available to predict the consequences of theuse of a particular device.1.3 These test methods set out guidelines for load types andmethods of applying loads.Methods for three static load typesand one fatigue test are defined for the comparative evaluationof spinal implant assemblies.1.4 These test methods establish guidelines for measuringdisplacements,determining the yield load,and evaluating thestiffness and strength of the spinal implant assembly.1.5 Some spinal constructs may not be testable in all testconfigurations.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.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 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2D638 Test Method for Tensile Properties of PlasticsE4 Practices for Force Verification of Testing MachinesE6 Terminology Relating to Methods of Mechanical TestingE177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodE739 Practice for StatisticalAnalysis of Linear or LinearizedStress-Life(S-N)and Strain-Life(-N)Fatigue DataE1150 Definitions of Terms Relating to Fatigue(Withdrawn1996)3F1582 Terminology Relating to Spinal ImplantsF2077 Test Methods For Intervertebral Body Fusion Devices3.Terminology3.1 Definitions:3.1.1 For definitions of terms relating to these test methods,see Terminology E6,Terminology F1582,and DefinitionsE1150.3.2 Definitions of Terms Specific to This Standard:3.2.1 active length of the longitudinal elementthe straightline distance between the center of attachment of the superioranchor and the center of attachment of the inferior anchor.3.2.2 angular displacement at 2%offset yield(degrees)the angular displacement of a construct measured via theactuator that produces a permanent angular displacement in theX-Y plane equal to 0.020 times the torsional aspect ratio(seePoint A in Fig.1).3.2.3 block moment armthe distance in the X direction inthe XY plane between the axis of the hinge pin and either(1)the center of the insertion point of an anchor(screws andbolts),(2)the furthest point of contact between the block andplate(anterior plates),or(3)the center point of attachment onthe roll pin farthest from the hinge pin(hooks and wires).1These test methods are under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and are the direct responsibility ofSubcommittee F04.25 on Spinal Devices.Current edition approved May 1,2015.Published July 2015.Originally approvedin 1996.Last previous edition approved in 2014 as F1717 14.DOI:10.1520/F1717-15.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.4 compressive or tensile bending stiffness(N/mm)thecompressive or tensile bending yield force divided by elasticdisplacement(see the initial slope of line BC in Fig.1).3.2.5 compressive or tensile bending ultimate load(N)themaximum compressive or tensile force in the X-Z plane appliedto a spinal implant assembly(see the force at Point E in Fig.1).The ultimate load should be a function of the device and not ofthe load cell or testing machine.3.2.6 compressive or tensile bending yield load(N)thecompressive or tensile bending