ASTM_F_1264_-_16e1.pdf

Designation:F1264161Standard Specification and Test Methods forIntramedullary Fixation Devices1This standard is issued under the fixed designation F1264;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.1NOTEEditorial changes were made throughout in November 2016.1.Scope1.1 This specification is intended to provide a characteriza-tion of the design and mechanical function of intramedullaryfixation devices(IMFDs),specify labeling and materialrequirements,provide test methods for characterization ofIMFD mechanical properties,and identify needs for furtherdevelopment of test methods and performance criteria.Theultimate goal is to develop a standard which defines perfor-mance criteria and methods for measurement of performance-related mechanical characteristics of IMFDs and their fixationto bone.It is not the intention of this specification to definelevels of performance or case-specific clinical performance ofthese devices,as insufficient knowledge to predict the conse-quences of the use of any of these devices in individual patientsfor specific activities of daily living is available.It is not theintention of this specification to describe or specify specificdesigns for IMFDs.1.2 This specification describes IMFDs for surgical fixationof the skeletal system.It provides basic IMFD geometricaldefinitions,dimensions,classification,and terminology;label-ing and material specifications;performance definitions;testmethods and characteristics determined to be important toin-vivo performance of the device.1.3 Multiple test methods are included in this standard.However,the user is not necessarily obligated to test using allof the described methods.Instead,the user should only select,with justification,test methods that are appropriate for aparticular device design.This may be only a subset of theherein described test methods.1.4 This specification includes four standard test methods:1.4.1 Static Four-Point Bend Test MethodAnnex A1 and1.4.2 Static Torsion Test MethodAnnex A2.1.4.3 Bending Fatigue Test MethodAnnex A3.1.4.4 Test Method for Bending Fatigue of IMFD LockingScrewsAnnex A4.1.5 A rationale is given in Appendix X1.1.6 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.2.Referenced Documents2.1 ASTM Standards:2A214/A214M Specification for Electric-Resistance-WeldedCarbon Steel Heat-Exchanger and Condenser TubesA450/A450M Specification for General Requirements forCarbon and Low Alloy Steel TubesD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsE4 Practices for Force Verification of Testing MachinesE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF86 Practice for Surface Preparation and Marking of Metal-lic Surgical ImplantsF138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F339 Specification for Cloverleaf Intramedullary Pins(Withdrawn 1998)3F383 Practice for Static Bend and Torsion Testing of In-tramedullary Rods(Withdrawn 1996)3F565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF1611 Specification for Intramedullary ReamersF2503 Practice for Marking Medical Devices and OtherItems for Safety in the Magnetic Resonance EnvironmentF2809 Terminology Relating to Medical and Surgical Mate-rials and Devices1This 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 May 1,2016.Published June 2016.Originallyapproved in 1989.Last previous edition approved in 2014 as F1264 14.DOI:10.1520/F1264-16E01.2For 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.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 2.2 AMS Standard:AMS 5050 Steel Tubing,Seamless,0.15 Carbon,MaximumAnnealed42.3 SAE Standard:SAE J524 Seamless Low-Carbon Steel Tubing Annealed forBending and Flaring43.Terminology3.1 Definitions for Geometric:3.1.1 closed section,nany cros