ASTM_F_2118_-_14.pdf

Designation:F211814Standard Test Method forConstant Amplitude of Force Controlled Fatigue Testing ofAcrylic Bone Cement Materials1This standard is issued under the fixed designation F2118;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 test method describes test procedures for evaluat-ing the constant amplitude,uniaxial,tension-compression uni-form fatigue performance of acrylic bone cement materials.1.2 This test method is relevant to orthopedic bone cementsbased on acrylic resins,as specified in Specification F451 andISO 16402.The procedures in this test method may or may notapply to other surgical cement materials.1.3 It is not the intention of this test method to define levelsof performance of these materials.It is not the intention of thistest method to directly simulate the clinical use of thesematerials,but rather to allow for comparison between acrylicbone cements to evaluate fatigue behavior under specifiedconditions.1.4 A rationale is given in Appendix X2.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 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:2E466 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 SystemE1823 Terminology Relating to Fatigue and Fracture TestingF451 Specification for Acrylic Bone Cement2.2 ISO Standard:ISO 16402 Flexural Fatigue Testing of Acrylic Resin Ce-ments Used in Orthopedics33.Terminology3.1 Unless otherwise given,the definitions for fatigue ter-minology given in Terminology E1823 will be used.3.2 Definitions:3.2.1 mean fatigue life at N cyclesthe average number ofcycles to failure at the specified load level.For the purposes ofthis test method,the fatigue life will be determined at 5 millionload cycles.A rationale for this is provided in X2.4.3.2.2 median fatigue life at a given stress levelthe numberof cycles to failure at which 50%of the tested samples failedat the specified stress level.3.2.3 runouta predetermined number of cycles at whichthe testing on a particular specimen will be stopped,and nofurther testing on that specimen will be performed.For thepurposes of this test method,the runout will be 5 million loadcycles.3.2.4 specimen failurethe condition at which the specimencompletely breaks or is damaged to such an extent that the loadframe is no longer able to apply the intended stress within therequired limits.3.2.5 stress levelthe value of stress at which a series ofduplicate tests are performed.For the purposes of this testmethod,the stress level is reported as the maximum stressapplied to the specimen.4.Summary of Test Method4.1 Uniform cylindrical reduced gage section test specimensare manufactured from acrylic bone cement and mounted in auniaxial fatigue frame.The specimen is subjected to fullyreversed tensile and compressive loading in a sinusoidal cyclicmanner at a specified frequency in phosphate buffered saline(PBS).The fatigue loading is continued until the specimen failsor a predetermined number of cycles(run-out limit)is reached.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Dec.1,2014.Published February 2015.Originallyapproved in 2001.Last previous edition approved in 2010 as F2118-10.DOI:10.1520/F2118-14.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 5.Significance and Use5.1 This test method describes a uniaxial,constantamplitude,fully reversed fatigue test to characterize the fatigueperformance of a uniform cylindrical waisted specimen manu-factured from acrylic bone cement.5.2 This test method considers two approaches to evaluatingthe fatigue performance of bone cement:5.2.1 Testing is conducted at three stress levels to charac-terize the general fatigue behavior of a cement over a range ofstresses.The stress level and resu