ASTM F116-2000(2004) Standard Specification for Medical Screwdriver Bits《医疗用螺丝刀标准规范》.pdf

1、Designation: F 116 00 (Reapproved 2004)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 (e) 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 surgica

3、l implants.1.2 This specification is based, in part, upon ISO 8319-1 andISO 8319-2.1.3 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 This standard does not purport to address all of thesa

4、fety 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:2E 18 Test Methods for Rockwell

5、 Hardness and RockwellSuperficial Hardness of Metallic MaterialsF 90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F 543 Specification and Test Methods for Metallic MedicalBone ScrewsF 565 Practice for Care and Handling of Orthop

6、edic Im-plants and InstrumentsF 899 Specification for Stainless Steel for Surgical Instru-mentsF 1744 Practice for Care and Handling of Stainless SteelSurgical Instruments2.2 ISO Standards:5832-5 Implants for SurgeryMetallic MaterialsPart 5:Wrought Cobalt-Chromium-Tungsten-Nickel Alloy35835 Implants

7、 for SurgeryMetal Bone Screws with Hex-agonal Driver Connection, Spherical Under Surface ofHead, Asymmetrical ThreadDimensions37153-1 Surgical InstrumentsMetallic MaterialsPart 1:Stainless Steel38319-1 Orthopaedic InstrumentsDrive ConnectionsPart 1: Keys for Use with Screws with Hexagon SocketHeads3

8、8319-2 Orthopaedic InstrumentsDrive ConnectionsPart 2: Screwdrivers for Single Slot Head Screws,screws with Cruciate Slot, and Cross-Recessed HeadScrews39268 Implants for SurgeryMetal Bone Screws with Coni-cal Under-Surface of HeadDimensions33. Classification3.1 This specification includes the follo

9、wing 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 speci

10、fication 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 1, anddescribed in Fig. 1.4.1.2 Type IICruciate-slot screwdriver bits must conformto the dimensions and

11、tolerances provided in Table 2, anddescribed in Fig. 2.4.1.3 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 Table 3, anddescribed i

12、n Fig. 4.4.1.5 Type VSquare screwdriver bits must conform to thedimensions provided in Table 4, and described in Fig. 5.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.21 on Osteosynt

13、hesis.Current edition approved Apr. 1, 2004. Published April 2004. Originallyapproved in 1969. Last previous edition approved in 2000 as F 116 00.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards

14、 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 10036.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United

15、States.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 portion of the screwdriver should befabricated from one of the following materials:5.1.1 Martensitic stainless steel (Specification F

16、 899 or ISO7153-1).5.1.2 Cold worked Cobalt-Chromium-Tungsten-Nickel al-loy (Specification F 90 or ISO 5832-5).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 t

17、o the procedures described in Test MethodsE 18.5.3 The shaft shall be firmly fixed to a handle of appropriatematerial.6. Finish and Marking6.1 The bit portion of the screwdriver shall be free of nicks,dents, and scratches.6.2 When size permits, the following information should belegibly marked on th

18、e 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 Manufacturing lot number6.2.5 Material (include ASTM designation, as appropriate).6.3 The marking should be such that the mechani

19、cal 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. Keywords8.1 bone screw; orthopaedic medical devices; screwdriver;surgical instrumentsFIG. 1 Dimensions of Single-Slot Screwdrive

20、r 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 +0.03 5.6 5.0 +3080.07 308FIG. 2 Dimensions of Cruciate-Slot Screwdriver BitTABLE 2 Dimensions and Tolerances of Cruciate-SlotS

21、crewdriver 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) Screwdriver BitF 116 00 (2004)2NOTEThe hexagon length (L) may be calculated from the following:L lR(measured with a radius gage).FIG. 4 D

22、imensions and Tolerances of HexagonalScrewdriver BitTABLE 3 Dimensions and Tolerances of Hexagonal ScrewdriverBitSizeHexagon WidthAcross Flats,s (mm)Hexagon WidthAcross Corners,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 0.02

23、53.5 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 0.025FIG. 5 Dimensions of Square Screwdriver BitsF 116 00 (2004)3APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 This spec

24、ification provides dimensions and tolerancesfor screwdrivers used to insert and remove medical bonescrews. 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,

25、 and ISO 9268.ASTM International takes no position respecting the validity of any patent rights asserted 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 su

26、ch rights, are entirely their own responsibility.This standard is subject to revision at any time by 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 addi

27、tional standardsand should be addressed to ASTM International Headquarters. Your comments will receive 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 th

28、e ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 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

29、 aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org).TABLE 4 Dimensions of Square Screwdriver BitsScrewdriverBit SizeWidth Across Flatsat Radius, A (mm)Width Across Cornersat Radius, B (mm)Width Across Flatsat Chamfer, C

30、 (mm)Width Across Cornersat Chamfer, D (mm)Length,E (mm)ChamferAngle, F ()ChamferDiameter, 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 0.76FIG. 6 Dimensions of Hexalobe Screwdriver BitsTABLE 5 Dimensions of Hexalobe Screwdriver BitsS

31、crewdriverBit 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 (2004)4