1、Designation:F180197(Reapproved 2014)Standard Practice forCorrosion Fatigue Testing of Metallic Implant Materials1This standard is issued under the fixed designation F1801;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of la
2、st 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 the procedure for performing cor-rosion fatigue tests to obtain S-N fatigue curves or statisticallyderiv
3、ed fatigue strength values,or both,for metallic implantmaterials.This practice describes the testing of axially loadedfatigue specimens subjected to a constant amplitude,periodicforcing function in saline solution at 37C and in air at roomtemperature.The environmental test method for implant mate-ri
4、als may be adapted to other modes of fatigue loading such asbending or torsion.While this practice is not intended to applyto fatigue tests on implantable components or devices,it doesprovide guidelines for fatigue tests with standard specimens inan environment related to physiological conditions.1.
5、2 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard.The values stated ineach system may not be exact equivalents;therefore,eachsystem shall be used independently of the other.Combiningvalues from the two systems may result in non-conformancewith the st
6、andard.1.3 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.Reference
7、d Documents2.1 ASTM Standards:2E4 Practices for Force Verification of Testing MachinesE466 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 P
8、ractice for Presentation of Constant Amplitude Fa-tigue Test Results for Metallic MaterialsE739 Practice for StatisticalAnalysis of Linear or LinearizedStress-Life(S-N)and Strain-Life(-N)Fatigue DataE1012 Practice for Verification of Testing Frame and Speci-men Alignment Under Tensile and Compressiv
9、e AxialForce ApplicationE1150 Definitions of Terms Relating to Fatigue(Withdrawn1996)3F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsG15 Terminology Relating to Corrosion and Corrosion Te
10、st-ing(Withdrawn 2010)32.2 ANSI Standard:ANSI B46.1 Surface Texture43.Terminology3.1 Definitions:3.1.1 The terminology used in conjunction with this practicecomplies to Terminology E1150 and Terminology G15.3.2 Definitions of Terms Specific to This Standard:3.2.1 S-N curvesS-N curves(also known as W
11、hler-curves)show the correlation between the applied stress(S)andthe counted number(N)of cycles to failure.4.Significance and Use4.1 Implants,particularly orthopedic devices,are usuallyexposed to dynamic forces.Thus,implant materials must havehigh fatigue resistance in the physiological environment.
12、4.1.1 This practice provides a procedure for fatigue testingin a simulated physiological environment.Axial tension-tension fatigue tests in an environmental test chamber arerecommended as a standard procedure.The axial fatigueloading shall comply with Practice E466 and Practice E467.4.1.1.1 Bending
13、and rotating bending beam fatigue tests ortorsion tests may be performed in a similar environmental cell.4.1.2 This practice is intended to assess the fatigue andcorrosion fatigue properties of materials that are employed or1This practice is under the jurisdiction ofASTM Committee F04 on Medical and
14、Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 1997.Last previous edition approved in 2009 as F1801 97(2009)1.DOI:10.1520/F1801-97R14.2For referenced ASTM
15、 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.4A
16、vailable 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 projected to be employed for implants.This practice is suitablefor studying the effects of different material treatments andsurface conditions on the fatigue behavior of implant materials.The loading mode of the actual implants may be different fromthat of this practice.