ASTM_F_564_-_10_2015.pdf

Designation:F56410(Reapproved 2015)Standard Specification and Test Methods forMetallic Bone Staples1This standard is issued under the fixed designation F564;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers characterization of the designand mechanical function of metallic staples used in the internalfixation of the muscular skeletal system.It is not the intentionof this specification to describe or specify specific designs formetallic bone staples.1.2 This specification includes the following four test meth-ods for measuring mechanical properties of metallic bonestaples:1.2.1 Test Method for Constant Amplitude Bending FatigueTests of Metallic Bone StaplesAnnex A1.1.2.2 Test Method for Pull-Out Fixation Strength of Metal-lic Bone StaplesAnnex A2.1.2.3 Test Method for Soft Tissue Fixation Strength ofMetallic Bone StaplesAnnex A3.1.2.4 Test Method for Elastic Static Bending of MetallicBone StaplesAnnex A4.1.3 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 MachinesE122 Practice for Calculating Sample Size to Estimate,WithSpecified Precision,the Average for a Characteristic of aLot or ProcessE467 Practice for Verification of Constant Amplitude Dy-namic Forces in an Axial Fatigue Testing SystemF75 Specification for Cobalt-28 Chromium-6 MolybdenumAlloy Castings and Casting Alloy for Surgical Implants(UNS R30075)F86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF382 Specification and Test Method for Metallic Bone PlatesF565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF601 Practice for Fluorescent Penetrant Inspection of Me-tallic Surgical ImplantsF629 Practice for Radiography of Cast Metallic SurgicalImplants3.Finish3.1 Staples conforming to this specification shall be finishedand identified in accordance with Practice F86,as appropriate.4.Inspection Practices4.1 Staples made in accordance with Specification F75should be inspected in accordance with Practice F601 orX-rayed in accordance with Practice F629.5.Care and Handling5.1 Staples should be cared for and handled in accordancewith Practice F565,as appropriate.6.Keywords6.1 bending test;bone fixation;fatigue test;fixation devices;metallic bone staples;orthopaedic medical devices;pullouttest;soft tissue fixation;surgical implants1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved March 1,2015.Published April 2015.Originallyapproved in 1985.Last previous edition approved in 2010 as F564 10.DOI:10.1520/F0564-10R15.2For 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 International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 ANNEXES(Mandatory Information)A1.TEST METHOD FOR CONSTANT AMPLITUDE BENDING FATIGUE TESTS OF METALLIC BONE STAPLESA1.1.ScopeA1.1.1 This test method covers procedures for the perfor-mance of constant amplitude fatigue testing of metallic staplesused in internal fixation of the musculoskeletal system.Thistest method may be used when testing in air at ambienttemperature or in an aqueous or physiological solution.A1.1.2 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.A1.1.3 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.A1.2.Summary of Test MethodA1.2.1 Metallic bone staples are tested under bending loadsuntil the specimen fails or a predetermined number of cycleshas been applied to it.Bending tests may be performed in oneof two modes:either pure,in-plane bending;or tension(orcompression)combined with in-plane bending.Tests usingeither of these methods may be conducted at ambient condi-tions or in aqueous or physiological solutions(at either roomtemperature or 37C).A1.3.Significance and UseA1.3.1 This test meth