ASTM_F_2580_-_13.pdf

Designation:F258013Standard Practice forEvaluation of Modular Connection of Proximally FixedFemoral Hip Prosthesis1This standard is issued under the fixed designation F2580;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 practice covers a procedure for the fatigue testingof metallic femoral hip prostheses used in hip joint replace-ments.This practice covers the procedures for the performanceof fatigue tests on metallic femoral hip stems using a cyclic,constant-amplitude force.It applies to hip prostheses thatutilize proximal metaphyseal fixation and are of a modularconstruct,and it is intended to evaluate the fatigue performanceof the modular connections in the metaphyseal filling(that is,proximal body)region of the stem.1.2 This practice is intended to provide useful,consistent,and reproducible information about the fatigue performance ofmetallic hip prostheses while held in a proximally fixatedmanner,with the distal end not held by a potting medium.1.3 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.4 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:2E467 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 MaterialsE1150 Definitions of Terms Relating to Fatigue(Withdrawn1996)32.2 ISO Standards:4ISO 72064 Determination of Endurance Properties ofStemmed Femoral Components with Application of Tor-sion3.Terminology3.1 Definitions:3.1.1 R value,nThe R value is the ratio of the minimumload to the maximum load.R 5minimum loadmaximum load3.2 Definitions of Terms Specific to This Standard:3.2.1 extractionremoval of the femoral hip implant fromthe femur during surgery.3.2.2 extractor holea hole in the proximal body of thestem in which an apparatus is placed to remove the implantfrom the femur.3.2.3 femoral headconvex spherical bearing member forarticulation with the natural acetabulum or prosthetic acetabu-lum.3.2.4 femoral head offsetthe perpendicular distance fromthe centerline of the implant stem to the center of the femoralhead.3.2.5 frontal planethe plane that lies in the medial-lateraldirection of the implant.Adduction occurs in this plane.3.2.6 implant centerlinethe axis that runs vertically fromthe proximal body of the implant,down the center of the stemto the distal end.3.2.7 pivot axisthe center of rotation of the pivot fixture(and prosthesis potted within it)within the test fixture setup;itslocation is determined by the intersection of the neck and stemcenterlines of the prothesis(Figs.1 and 2).1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved Feb.1,2013.Published February 2013.Originallyapproved in 2007.Last previous edition approved in 2009 as F2580 09.DOI:10.1520/F2580-13.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.4Available 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 3.2.8 pivot fixturethe fixture in which the specimen ispotted,and is attached to the main test fixture;characterized bytwo pins on the side that serve as the pivot axis.3.2.9 rotational planethe plane that lies perpendicular tothe stem axis of the implant.3.2.10 sagittal planethe plane that lies perpendicular tothe Frontal plane;flexion occurs in this plane.4.Significance and Use4.1 This practice can be used to describe the effects ofmaterials,manufacturing,and design variables on the fatigueperformance of metallic femoral hip prostheses subject tocyclic loading for large numbers of cycles.FIG.1 Free Body Diagram of Test SetupFIG.2 Schematic Representation of the Test Set-upF2580 132 4.2 The loading of femoral hip designs in vivo will,ingeneral,differ from the loading defined in this practice.Theresults obtained here cannot be used to directly predict in vivoperformance.However,this practice is designed to allow forcompar