ASTM_F_2346_-_05_2011.pdf

Designation:F234605(Reapproved 2011)Standard Test Methods forStatic and Dynamic Characterization of Spinal ArtificialDiscs1This standard is issued under the fixed designation F2346;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 specify the materials and methodsfor the static and dynamic testing of artificial intervertebraldiscs.1.2 These test methods are intended to provide a basis forthe mechanical comparison among past,present,and futurenon-biologic artificial intervertebral discs.These test methodsallow comparison of artificial intervertebral discs with differentintended spinal locations(cervical,thoracic,and lumbar)andmethods of application to the intervertebral spaces.These testmethods are intended to enable the user to mechanicallycompare artificial intervertebral discs and do not purport toprovide performance standards for artificial intervertebraldiscs.1.3 These test methods describe static and dynamic tests byspecifying load types and specific methods of applying theseloads.These tests are designed to allow for the comparativeevaluation of artificial intervertebral discs.1.4 These test methods do not purport to address all clini-cally relevant failure modes for artificial intervertebral discs,some of which will be device specific.For example,these testmethods do not address the implants resistance to expulsion orimplant wear resistance under expected in vivo loads andmotions.In addition,the biologic response to wear debris is notaddressed in these test methods.1.5 Requirementsareestablishedformeasuringdisplacements,determining the yield load or moment,andevaluating the stiffness of artificial intervertebral discs.1.6 Some artificial intervertebral discs may not be testablein all test configurations.1.7 The values stated in SI units are to be regarded as thestandard with the exception of angular measurements,whichmay be reported in terms of either degrees or radians.1.8 The use of this standard may involve the operation ofpotentially hazardous equipment.This standard does not pur-port to address all of the safety concerns,if any,associatedwith its use.It is the responsibility of the user of this standardto establish appropriate safety and health practices anddetermine the applicability of regulatory limitations prior touse.2.Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesE6 Terminology Relating to Methods of Mechanical TestingE466 Practice for Conducting Force Controlled ConstantAmplitude Axial Fatigue Tests of Metallic MaterialsE467 Practice for Verification of Constant Amplitude Dy-namic Forces in an Axial Fatigue Testing SystemE468 Practice for Presentation of Constant Amplitude Fa-tigue Test Results for Metallic MaterialsE1823 Terminology Relating to Fatigue and Fracture TestingF1582 Terminology Relating to Spinal ImplantsF2077 Test Methods For Intervertebral Body Fusion Devices3.Terminology3.1 All definitions below supersede definitions containedwithin Terminologies E6,E1823,F1582,and Practices E466,E467.3.2 Definitions:3.2.1 artificial intervertebral disca synthetic structure thatis permanently implanted in the disc space between twoadjacent vertebral bodies to provide spinal column support andallow intervertebral motion.3.2.2 coordinate system/axesthree orthogonal axes aredefined by Terminology F1582.The center of the coordinatesystem is located at the geometric center of the artificialintervertebral disc.Alternative coordinate systems may be usedwith justification.The XY-plane is to bisect the superior andinferior surfaces that are intended to simulate the adjacent1These test methods are under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devicesand is the direct responsibility ofSubcommittee F04.25 on Spinal Devices.Current edition approved Dec.1,2011.Published January 2012.Originallyapproved in 2005.Last previous edition approved in 2005 as F2346 05.DOI:10.1520/F2346-05R11.2For 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 vertebral end plates.The positive Z-axis is to be directedperpendicular to the bisector of the disc space,oriented in thesuperior direction.The positive X-axis is parallel to theintervertebral space,oriented in the anterior direction and thepositive Y-axis is parallel to the disc space,oriented in the leftdirection.Force components parallel to the XY-plane are shearcomponents of loading.The compressive axial force is definedto be the co