ASTM_F_2345_-_03_2013.pdf

Designation:F234503(Reapproved 2013)Standard Test Methods forDetermination of Static and Cyclic Fatigue Strength ofCeramic Modular Femoral Heads1This standard is issued under the fixed designation F2345;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 evaluation of the static andcyclic fatigue strength of ceramic modular femoral heads,mounted on a cone as used on the femoral stem of the total hiparthroplasty.1.2 These test methods were primarily developed for evalu-ation of ceramic(Specifications F603 and F1873)head designson metal cones but may have application to other materials.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:2E4 Practices for Force Verification of Testing MachinesF603 Specification for High-Purity Dense Aluminum Oxidefor Medical ApplicationF1873 Specification for High-Purity Dense Yttria TetragonalZirconium Oxide Polycrystal(Y-TZP)for Surgical Im-plant Applications(Withdrawn 2007)3F1875 Practice for Fretting Corrosion Testing of ModularImplant Interfaces:Hip Femoral Head-Bore and ConeTaper Interface2.2 Other Documents:DIN 4768 Determination of Surface Roughness Ra,Rz,andRmaxwith Electric Stylus Instruments;Basic Data4FDA Guidance Document for the Preparation of PremarketNotifications for Ceramic Ball Hip Systems(draft Jan.10,1995)53.Terminology3.1 Definitions:3.1.1 circularitydeviations of taper cross section from aperfect circle.3.1.2 conethe proximal end of the femoral componentfabricated as a truncated right cone and used to engage with amating conical bore of the modular femoral head.3.1.3 cone angleincluded angle of cone(Fig.1).3.1.4 femoral neck-axiscenterline or axis of symmetry ofthe femoral cone.3.1.5 head sizenominal spherical diameter of the head(generally standardized,but not limited to 22,26,28,32,and36 mm for total hips.)3.1.6 installation loadthe force,applied at 0 from femo-ral neck axis,used to settle the head on the cone prior totesting.3.1.7 load axisline of action of the compressive forceapplied to the head.3.1.8 load axis anglethe measured angle“L”between theline of action of the applied force and femoral neck axis(seeFig.5).3.1.9 load magnitudethe peak(absolute value)compres-sive force of the applied constant amplitude cyclic force.3.1.10 load raterate of applied compressive force.3.1.11 stroke ratethe rate of the stroke displacement of theforce applicator.3.1.12 surface finishmeasured roughness of surface oftaper cone or head bore as determined by DIN 4768.1This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved March 15,2013.Published April 2013.Originallyapproved in 2003.Last previous edition approved in 2008 as F2345 03(2008).DOI:10.1520/F2345-03R13.2For 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 Beuth Verlag GmbH(DINDIN Deutsches Institut furNormung e.V.),Burggrafenstrasse 6,10787,Berlin,Germany.5Available from Food and Drug Administration(FDA),5600 Fishers Ln.,Rockville,MD 20857.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 3.1.13 test frequencythe rate of cyclic repetition of fatigueloading in cycles per second.3.1.14 THRtotal hip replacement.4.Significance and Use4.1 These test methods can be used to determine the effectsof head and cone materials,design variables,manufacturing,and other conditions on the static and cyclic load-carryingability of modular femoral heads mounted on the cones offemoral stem prostheses.4.2 These test methods may use actual femoral prostheses orneck-cone models of simplified geometry with the samegeometrical and material characteristics as in the implants.Ineither case,the matching metallic cone region of the testspecimen selected shall be of the same material,tolerances,andfinishing as the final femoral stem prosthesis.4.3 The static test data may yield valuable informationabout the relative strengths and merits of different head andcone designs for particular application