1、Designation:F207714Test Methods ForIntervertebral Body Fusion Devices1This standard is issued under the fixed designation F2077;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 indicat
2、es the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This test method covers the materials and methods forthe static and dynamic testing of intervertebral body fusiondevice assemblies,spinal implants designed to promote a
3、rthro-desis at a given spinal motion segment.1.2 This test method is intended to provide a basis for themechanical comparison among past,present,and future non-biologic intervertebral body fusion device assemblies.This testmethod allows comparison of intervertebral body fusion deviceassemblies with
4、different intended spinal locations and meth-ods of application to the intradiscal spaces.This test method isintended to enable the user to compare intervertebral bodyfusion device assemblies mechanically and does not purport toprovide performance standards for intervertebral body fusiondevice assem
5、blies.1.3 The test method describes static and dynamic tests byspecifying force types and specific methods of applying theseforces.These tests are designed to allow for the comparativeevaluation of intervertebral body fusion device assemblies.1.4 These tests are designed to characterize the structur
6、alintegrity of the device and are not intended to test thebone-implant interface.1.5 This test method does not address expulsion testing ofintervertebral body fusion device assemblies(see 1.4).1.6 Guidelines are established for measuring displacements,determining the yield force or moment,evaluating
7、 the stiffness,and strength of the intervertebral body fusion device assem-blies.1.7 Some intervertebral body fusion device assemblies maynot be testable in all test configurations.1.8 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstand
8、ard,with the exception of angular measurements,whichmay be reported in terms of either degrees or radians.1.9 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 h
9、ealth practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesE6 Terminology Relating to Methods of Mechanical TestingE177 Practice for Use of the Terms Precision and Bias inAST
10、M Test MethodsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodE1823 Terminology Relating to Fatigue and Fracture TestingE2309 Practices for Verification of Displacement MeasuringSystems and Devices Used in Material Testing MachinesF1582 Terminology Rel
11、ating to Spinal Implants3.Terminology3.1 For definition of terms refer to Terminology E6,E1823,and F1582.3.2 Definitions of Terms Specific to This Standard:3.2.1 coordinate system/axes,nThree orthogonal axes aredefined by Terminology F1582.The center of the coordinatesystem is located at the geometr
12、ic center of the intervertebralbody fusion device assembly.The XY plane is to bisect thesagittal plane angle between superior and inferior lines(sur-faces)that are intended to simulate the adjacent vertebral endplates.The positive Z axis is to be directed superiorly.Forcecomponents parallel to the X
13、Y plane are shear components ofloading.The compressive axial force is defined to be thecomponent in the negative Z direction.Torsional force isdefined to be the component of moment parallel to the Z axis.3.2.2 crack,nan externally visible physical discontinuityin the form of a narrow opening that ar
14、ises from mechanicalforces.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25.Current edition approved Oct.1,2014.Published December 2014.Originallypublished in 2000.Last previous editio
15、n approved in 2011 as F2077 11 DOI:10.1520/F2077-14.2For 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
16、 International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.2.3 fatigue life,nthe number of cycles,N,that theintervertebral body fusion device assembly can sustain at aparticular force or moment before mechanical or functionalfailure occurs.3.2.4 functional failure,npermanent deformation that ren-ders the intervertebral body fusion device assembly ineffectiveor unable to resist force and/or maintain attachment adequately.3.2.5 ideal insertion location,nthe i
