ASTM_F_1541_-_02_2015.pdf

Designation:F154102(Reapproved 2015)Standard Specification and Test Methods forExternal Skeletal Fixation Devices1This standard is issued under the fixed designation F1541;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 specification provides a characterization of thedesign and mechanical function of external skeletal fixationdevices(ESFDs),test methods for characterization of ESFDmechanical properties,and identifies needs for further devel-opment of test methods and performance criteria.The ultimategoal is to develop a specification,which defines performancecriteria and methods for measurement of performance-relatedmechanical characteristics of ESFDs and their fixation to bone.It is not the intention of this specification to define levels ofperformance or case-specific clinical performance of thedevices,as insufficient knowledge is available to predict theconsequences of the use of any of these devices in individualpatients for specific activities of daily living.Furthermore,it isnot the intention of this specification to describe or specifyspecific designs for ESFDs.1.2 This specification describes ESFDs for surgical fixationof the skeletal system.It provides basic ESFD geometricaldefinitions,dimensions,classification,and terminology;mate-rial specifications;performance definitions;test methods;andcharacteristics determined to be important to the in-vivoperformance of the device.1.3 This specification includes a terminology and classifi-cation annex and five standard test method annexes as follows:1.3.1 Classification of External FixatorsAnnex A1.1.3.2 TestMethodforExternalSkeletalFixatorConnectorsAnnex A2.1.3.3 Test Method for Determining In-Plane CompressiveProperties of Circular Ring or Ring Segment BridgeElementsAnnex A3.1.3.4 Test Method for External Skeletal Fixator JointsAnnex A4.1.3.5 Test Method for External Skeletal Fixator Pin Anchor-age ElementsAnnex A5.1.3.6 TestMethodforExternalSkeletalFixatorSubassembliesAnnex A6.1.3.7 Test Method for External Skeletal Fixator/ConstructsSubassembliesAnnex A7.1.4 A rationale is given in Appendix X1.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 The following safety hazards caveat pertains only to thetest method portions(Annex A2 Annex A6):1.7 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:2A938 Test Method for Torsion Testing of WireD790 Test Methods for Flexural Properties of Unreinforcedand Reinforced Plastics and Electrical Insulating Materi-alsE4 Practices for Force Verification of Testing MachinesF67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI(Extra Low Interstitial)Alloy for SurgicalImplant Applications(UNS R56401)F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for SurgicalImplants(UNS S31673)F366 Specification for Fixation Pins and WiresF543 Specification and Test Methods for Metallic MedicalBone ScrewsF544 Reference Chart for Pictorial Cortical Bone Screw1This 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 Sept.1,2015.Published October 2015.Originallypublished as F1541 94.Last previous edition approved in 2011 as F1541 02(2011)1.DOI:10.1520/F1541-02R15.2For 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 Classification(Withdrawn 1998)3F1058 Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire and Strip forSurgical Implant Applications(UNS R30003 and UNSR30008)F1264 Specification and Test Methods for IntramedullaryFixation DevicesF1472 Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications(UNSR56400)F1713 Specification for Wrought Titanium-13Niobium-13Zirconium Alloy for Surgical Implant Applications(UNS R58130)3.Terminology3.1 DefinitionsThe defi