ASTM F116-2000(2009) Standard Specification for Medical Screwdriver Bits《医疗用螺丝刀标准规范》.pdf

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1、Designation: F 116 00 (Reapproved 2009)Standard Specification forMedical Screwdriver Bits1This standard is issued under the fixed designation F 116; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revision. A numbe

2、r 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 covers the acceptable dimensions andtolerances for bits of screwdrivers to insert and remove metalscrews used as surgical

3、 implants.1.2 This specification is based, in part, upon ISO 83191and ISO 83192.1.3 The screwdrivers with the bits described in this speci-fication are suitable for use with screws described in Specifi-cation F 543, ISO 5835, and ISO 9268.1.4 The values stated in SI units are to be regarded asstanda

4、rd. 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 applic

5、a-bility of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E18 Test Methods for Rockwell Hardness of MetallicMaterialsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 543 Specification and Test

6、Methods for Metallic MedicalBone ScrewsF 565 Practice for Care and Handling of Orthopedic Im-plants and InstrumentsF 899 Specification for Wrought Stainless Steels for Surgi-cal InstrumentsF 1744 Guide for Care and Handling of Stainless SteelSurgical Instruments2.2 ISO Standards:3ISO 58325 Implants

7、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 8

8、3191 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 Scr

9、ews withConical Under-Surface of HeadDimensions3. 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 VSquar

10、e 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 must conform tothe dimensions and tolerances provided in Table

11、 1, anddescribed in Fig. 1.4.1.2 Type IICruciate-slot screwdriver bits must conformto the dimensions and tolerances provided in Table 2, anddescribed in Fig. 2.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsib

12、ility ofSubcommittee F04.21 on Osteosynthesis.Current edition approved April 1, 2009. Published April 2009. Originallyapproved in 1969. Last previous edition approved in 2004 as F 116 00(2004).2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at se

13、rviceastm.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.1Copyright ASTM International, 100 Barr H

14、arbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.4.1.3 Type IIICross-slot (Modified Phillips) screwdriverbits must conform to the dimensions and tolerances provided inFig. 3.4.1.4 Type IVHexagonal screwdriver bits must conform tothe dimensions and tolerances provided in Tabl

15、e 3, anddescribed in Fig. 4.4.1.5 Type VSquare screwdriver bits must conform to thedimensions provided in Table 4, and described in Fig. 5.4.1.6 Type VIHexalobe screwdriver bits must conform tothe dimensions provided in Table 5, and described in Fig. 6.5. Material Requirements5.1 The bit and shaft p

16、ortion of the screwdriver should befabricated from one of the following materials:5.1.1 Martensitic stainless steel (Specification F 899 orISO 71531).5.1.2 Cold worked Cobalt-Chromium-Tungsten-Nickel al-loy (Specification F90or ISO 58325).5.2 The hardness of the material of the bit and shaft portion

17、shall 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 fixed to a handle of appropriatematerial.6. Finish and Marking6.1 The bit portion of the screwdr

18、iver shall be free of nicks,dents, and scratches.6.2 When size permits, the following information should belegibly marked on the shaft or handle of the screwdriver (inorder of preference):6.2.1 Manufacturers name or logo6.2.2 Size (for Type IV through VI screwdriver bits)6.2.3 Catalog number6.2.4 Ma

19、nufacturing lot number6.2.5 Material (include ASTM designation, as appropriate).6.3 The marking should be such that the mechanical integ-rity of the screwdriver is not compromised.7. Care and Handling7.1 Screwdrivers should be handled in accordance withPractices F 565 and F 1744, as appropriate.8. K

20、eywords8.1 bone screw; orthopaedic medical devices; screwdriver;surgical instrumentsFIG. 1 Dimensions of Single-Slot Screwdriver BitTABLE 1 Dimensions and Tolerances of Single-Slot ScrewdriverBitSlot Thickness, a(mm)Slot Width, b(mm; maximum)Slot Angle, a(degrees)1.10 +0.03 4.8 5.0 +3080.07 3081.10

21、+0.03 5.6 5.0 +3080.07 308FIG. 2 Dimensions of Cruciate-Slot Screwdriver BitTABLE 2 Dimensions and Tolerances of Cruciate-SlotScrewdriver BitSlot Thickness, a(mm)Slot Width, b(mm; maximum)1.10 +0.03 4.80.071.10 +0.03 5.60.07FIG. 3 Dimensions and Tolerances of Cross-Slot (ModifiedPhillips) Screwdrive

22、r BitF 116 00 (2009)2NOTEThe hexagon length (L) may be calculated from the following:L lR(measured with a radius gage).FIG. 4 Dimensions and Tolerances of HexagonalScrewdriver BitTABLE 3 Dimensions and Tolerances of Hexagonal ScrewdriverBitSizeHexagon WidthAcross Flats,s (mm)Hexagon WidthAcross Corn

23、ers,e (mm)Hexagon Length, L(mm; minimum)1.5 1.500 +0.000 1.670 +0.020 2.00.025 0.0202.5 2.500 +0.000 2.820 +0.025 3.00.030 0.0253.5 3.500 +0.000 3.956 +0.025 4.00.030 0.0254.5 4.500 +0.000 5.106 +0.025 5.00.030 0.0255/32 3.950 +0.000 4.471 +0.025 5.00.050 0.0253/16 4.735 +0.000 5.373 +0.025 6.00.050

24、 0.025FIG. 5 Dimensions of Square Screwdriver BitsTABLE 4 Dimensions of Square Screwdriver BitsScrewdriverBit SizeWidth Across Flatsat Radius, A (mm)Width Across Cornersat Radius, B (mm)Width Across Flatsat Chamfer, C (mm)Width Across Cornersat Chamfer, D (mm)Length,E (mm)ChamferAngle, F ()ChamferDi

25、ameter, G(mm)1.0 0.84 1.19 0.67 0.95 1.25 24 0.401.5 1.16 1.64 0.96 1.38 1.57 28 0.482.0 2.03 2.87 1.20 1.70 2.69 26.5 0.76F 116 00 (2009)3APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 This specification provides dimensions and tolerancesfor screwdrivers used to insert and remove medical bones

26、crews. It is intended to provide assurances to the surgical staffthat the specified screwdriver will fit and perform acceptablywhen used with the bone screws specified in SpecificationF 543, ISO 5835, and ISO 9268.ASTM International takes no position respecting the validity of any patent rights asse

27、rted in connection with any item mentionedin this standard. Users of this standard are expressly advised that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by

28、 the responsible technical committee and must be reviewed every five years andif not revised, either reapproved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will recei

29、ve careful consideration at a meeting of theresponsible technical committee, which you may attend. If you feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM Inter

30、national, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individual reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or throug

31、h the ASTM website(www.astm.org).FIG. 6 Dimensions of Hexalobe Screwdriver BitsTABLE 5 Dimensions of Hexalobe Screwdriver BitsScrewdriverBit SizeMajorDiameter A(mm)MinorDiameter B(mm)InternalRadius C(mm)ExternalRadius D(mm)Length E(mm)ChamferDiameter F(mm)4 1.27 0.89 0.31 0.08 1.52A5 1.40 1.00 0.34 0.10 1.52A6 1.68 1.19 0.39 0.12 1.52A8 2.27 1.60 0.55 0.15 1.78A10 2.69 1.91 0.62 0.20 2.03A15 3.23 2.29 0.74 0.24 2.16A20 3.81 2.71 0.87 0.28 2.29 2.9625 4.36 3.07 0.96 0.34 2.54 3.3330 5.45 3.86 1.22 0.42 3.18 4.11AChamfer not necessary.F 116 00 (2009)4