ASTM_F_116_-_12.pdf

Designation:F11612Standard Specification forMedical Screwdriver Bits1This standard is issued under the fixed designation F116;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 the acceptable dimensions andtolerances for bits of screwdrivers to insert and remove metalscrews used as surgical implants.1.2 This specification is based,in part,upon ISO 83191,ISO 83192,and ISO 10664.1.3 The screwdrivers with the bits described in this speci-fication are suitable for use with screws described in Specifi-cation F543,ISO 5835,and ISO 9268.1.4 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.5 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:2E18 Test Methods for Rockwell Hardness of Metallic Ma-terialsF90 SpecificationforWroughtCobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions(UNS R30605)F543 Specification and Test Methods for Metallic MedicalBone ScrewsF565 Practice for Care and Handling of Orthopedic Implantsand InstrumentsF899 Specification for Wrought Stainless Steels for SurgicalInstrumentsF1744 Guide for Care and Handling of Stainless SteelSurgical Instruments2.2 ISO Standards:3ISO 58325 Implants for SurgeryMetallic MaterialsPart 5:Wrought Cobalt-Chromium-Tungsten-Nickel Al-loyISO 5835 Implants for SurgeryMetal Bone Screws withHexagonal Driver Connection,Spherical Under Surface ofHead,Asymmetrical ThreadDimensionsISO 71531 Surgical InstrumentsMetallic MaterialsPart 1:Stainless SteelISO 83191 Orthopaedic InstrumentsDrive ConnectionsPart 1:Keys for Use with Screws with Hexagon SocketHeadsISO 83192 Orthopaedic InstrumentsDrive ConnectionsPart 2:Screwdrivers for Single Slot Head Screws,screws with Cruciate Slot,and Cross-Recessed HeadScrewsISO 9268 Implants for SurgeryMetal Bone Screws withConical Under-Surface of HeadDimensionsISO 10664 Hexalobular Internal Driving Feature for Boltsand Screws3.Classification3.1 This specification includes the following types of bitsfor medical screwdrivers:3.1.1 Type ISingle-slot bit.3.1.2 Type IICruciate-slot bit.3.1.3 Type IIICross-slot(Modified Phillips)bit.3.1.4 Type IVHexagonal bit.3.1.5 Type VSquare bit.3.1.6 Type VIHexalobe bit.4.Dimensions and Tolerances4.1 Screwdriver bits conforming to this specification shallbe fabricated in accordance with the dimensions and tolerancesdescribed below:4.1.1 Type ISingle-slot screwdriver bits shall conform tothe dimensions and tolerances provided in Table 1,and shownin Fig.1.4.1.2 Type IICruciate-slot screwdriver bits shall conformto the dimensions and tolerances provided in Table 2,andshown in Fig.2.1This 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 Oct.1,2012.Published November 2012.Originallyapproved in 1969.Last previous edition approved in 2009 as F116 00(2009).DOI:10.1520/F0116-12.2For 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.3Available 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 4.1.3 Type IIICross-slot(Modified Phillips)screwdriverbits shall conform to the dimensions and tolerances provided inFig.3.4.1.4 Type IVHexagonal screwdriver bits shall conform tothe dimensions and tolerances provided in Table 3,and shownin Fig.4.4.1.5 Type VSquare screwdriver bits shall conform to thegeneral dimensions provided in Table 4,and shown in Fig.5.4.1.6 Type VIHexalobe screwdriver bits shall conform tothe general dimensions provided in Table 5,and shown in Fig.6.5.Material Requirements5.1 The bit and shaft portion of the screwdriver should befabricated from one of the following materials:5.1.1 Martensitic stainless steel(Specification F899 or ISO71531).5.1.2 Cold worked Cobalt-Chromium-Tungsten-Nickel al-loy(Specification F90 or ISO 58325).5.2 The hardness of the material of the bit and shaft portionshall be 4555(stainless steel)or 4550(Cobalt-Chromium-Tungsten-Nickel alloy)when measured on the Rockwell Cscale according to the procedures described in Test MethodsE18.5.3 The shaft shall be firmly