ASTM F116-2012 Standard Specification for Medical Screwdriver Bits《医疗用螺丝刀的标准规范》.pdf

1、Designation: F116 12Standard 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. A number in parentheses ind

2、icates the year of last reapproval. A superscriptepsilon () 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 s

3、pecification 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 ot

4、her 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

5、of regulatory limitations prior to use.2. Referenced Documents2.1 ASTM Standards:2E18 Test Methods for Rockwell Hardness of Metallic Ma-terialsF90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applica-tions (UNS R30605)F543 Specification and Test Methods

6、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 SurgeryMeta

7、llic 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 Orthopaedi

8、c 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

9、 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 Phillip

10、s) 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 confo

11、rm 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 Mate

12、rials 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 t

13、he 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

14、 10036, http:/www.ansi.org.Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States14.1.3 Type IIICross-slot (Modified Phillips) screwdriverbits shall conform to the dimensions and tolerances provided inFig. 3.4.1.4 Type IVHexagonal screwdrive

15、r 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 T

16、able 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 o

17、r 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 fixed to a handle of a

18、ppropriatematerial.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 the shaft or handle of the screwdriver (inorder of preference):6.2.1 Manufacturers name or logo6.2.2

19、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 mechanical integ-rity of the screwdriver is not compromised.7. Care and Handling7.1 Screwdrivers should be

20、 handled in accordance withPractices F565 and F1744, as appropriate.8. Keywords8.1 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,

21、b(mm; maximum)Slot Angle, a(degrees)1.10 +0.03 4.8 5.0 +300.07 301.10 +0.03 5.6 5.0 +300.07 30FIG. 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 D

22、imensions and Tolerances of Cross-Slot (Modified Phil-lips) Screwdriver BitF116 122NOTE 1The 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 Screwdrive

23、rBitSizeHexagon 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 0.0253.5 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 4.4

24、71 +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 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 Co

25、rnersat 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 0.76F116 123APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 This specification provides dimensions and tolerancesf

26、or 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 SpecificationF543, ISO 5835, and ISO 9268.X1.2 During a periodic review of

27、 the standard, the Subcom-mittee established that there are no consensus dimensions foreither of these bit types. However, an ISO standard relevant toHexalobe screwdriver bits was identified and included. Dele-tion of the information on these bits from the standard was feltto detract from the value

28、of the standard as a whole.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 infri

29、ngement of such 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 standar

30、d or for additional 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 view

31、s known to the 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 contactin

32、g ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).FIG. 6 Dimensions of Hexalobe Screwdriver

33、 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.F116 124