ASTM_F_366_-_10_2015.pdf

Designation:F36610(Reapproved 2015)Standard Specification forFixation Pins and Wires1This standard is issued under the fixed designation F366;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 functional dimensions forfixation pins and wires.1.2 In recognition of many broad and varied uses of suchpins and wires,many options are included.A variety,but notnecessarily all,of the options are illustrated in Figs.1-3.1.3 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:2F67 Specification for Unalloyed Titanium,for Surgical Im-plant Applications(UNS R50250,UNS R50400,UNSR50550,UNS R50700)F75 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 ImplantsF90 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Steel Bar and Wire for SurgicalImplants(UNS S31673)F368 Specification for Fixation Pins-Knowles and HagieTypes(Withdrawn 1982)3F562 SpecificationforWrought35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical ImplantApplications(UNS R30035)F563 SpecificationforWroughtCobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloyfor Surgical Implant Applications(UNS R30563)(With-drawn 2005)3F1314 Specification for Wrought Nitrogen Strengthened 22Chromium13 Nickel5 Manganese2.5 MolybdenumStainless Steel Alloy Bar and Wire for Surgical Implants(UNS S20910)F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants(UNSR31537,UNS R31538,and UNS R31539)F1586 Specification for Wrought Nitrogen Strengthened21Chromium10Nickel3Manganese2.5Molybdenum Stainless Steel Alloy Bar for SurgicalImplants(UNS S31675)3.Materials3.1 Fixation pins and wires shall be fabricated from materialconforming to one of the followingASTM Specifications:F67,F75,F90,F136,F138,F562,F563,F1314,F1537,and F1586.4.Performance Requirements4.1 Factors considered to be important,but for which valuesand test methods have not been established,are bendingstrength,fatigue strength,breaking strength(Knowles Typeonly),torsion strength,and ductility.5.Dimensions and Characteristics5.1 Fixation pins and wires shall be fabricated in accordancewith the dimensions illustrated in Figs.1-4.5.2 Fixation pins and wires shall have surfaces prepared andmarked in accordance with Practice F86.5.2.1 Optional marking on the fixation pins and wires shallidentify the manufacturer or distributor.6.Packaging and Labeling6.1 Packaging shall be adequate to protect the fixation pinsand wires during shipment.6.2 Labeling for fixation pins and wires shall include:6.2.1 Product name,1This 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 1973.Last previous edition approved in 2010 as F366 10.DOI:10.1520/F0366-10R15.2For 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.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 States1 6.2.2 Size,on the immediate container,6.2.2.1 Length,6.2.2.2 Diameter(if round)or cross-sectional size(if squareof hexagonal),that is,6.4 mm square,and6.2.3 ASTM material specification Designation number.7.Keywords7.1 fixation materials;flexible surgical wire;orthopaedicmedical devices;wire-surgical implantsNOTE1Pins and wires may be smooth shank or threaded.NOTE2Point angle and helix angle,where applicable,is as specified by manufacturer.NOTE3On square or triangular shanks,flats are equal and corners are on the same circumference as the pin diameter.Shank diameters on pins largerthan 3.2 mm may be reduced.NOTE4Optional designs,both ends pointed or point with suture hole.FIG.1 Fixation Pins and WiresF366 10(2015)2 NOTE1Shall be made of one piece of material;that is,not an assembly of two or more pieces.NOTE2Thread major diameter may be the same or larger than the shaft diameter.NOTE3Thread length shall be optional to suit intende