ASTM F2062-2000(2006) Standard Specification for Square Drive Interconnections on Surgical Instruments《与外科植入物相互连接的方形扭杆标准规范》.pdf

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1、Designation: F 2062 00 (Reapproved 2006)Standard Specification forSquare Drive Interconnections on Surgical Instruments1This standard is issued under the fixed designation F 2062; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the

2、 year of last revision. A number 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 applies to interconnections of surgicalinstruments used for drilling, tapping, driving, o

3、r placing ofmedical devices during surgery.1.2 This specification includes dimensions and tolerancesfor both driving and driven elements.1.3 The specifications given in ASME B107.4M-1995 aredesigned for industrial applications and are considered tooloose for surgical applications. Springs used for i

4、ndustrialapplications are generally made from carbon steel and arecapable of higher loads than their stainless steel counterparts.The specifications given in this standard have been written tolessen the chance of accidental disengagement of surgicalinstruments. This accidental disengagement could in

5、jure thepatient or end user, or damage or contaminate the instrument.1.4 The values stated in SI units are to be regarded as thestandard. Inch-pound values are in separate tables.2. Referenced Documents2.1 ASTM Standards:2F 899 Specification for Stainless Steels for Surgical Instru-ments2.2 Other St

6、andard:ASME B107.4M-1995 (Revision of ANSI B107.4-1982),Driving and Spindle Ends for Portable Hand, Impact, Air,and Electric Tools Percussion Tools Excluded33. Terminology3.1 Definitions of Terms Specific to This Standard:3.1.1 drillingthe act of forming a hole.3.1.2 drivingthe act of turning, pushi

7、ng, or pulling asurgical instrument to place a medical device during surgery.3.1.3 square drivea male or female interconnection withfour driving surfaces that are of equal width and perpendicularto each other.3.1.4 tappingthe act of forming threads.4. Material4.1 This specification is intended to ap

8、ply only to stainlesssteel instruments that conform to Specification F 899. If othertypes of materials are used to interconnect with stainless steelinstruments, then they should adhere to this specification.5. Gauge Use and Design5.1 Tables 1-8 are descriptive and not restrictive, and are notintende

9、d to preclude the manufacture of product or gaugeswhich are otherwise in accordance with this specification.5.2 Manufacturers may use gauges with tighter dimensionsor tolerances than shown herein to ensure device acceptance.5.3 The extreme size for all limit (GO and NO-GO) gaugesshall not exceed the

10、 extreme limits of interconnections speci-fied within this specification. All variations (manufacturingtolerance, calibration error, wear allowance, and so forth) in thegauges, whatever their cause or purpose, shall bring thesegauges within the extreme limits of the gauge size specified inthis speci

11、fication. Thus, a gauge representing a minimum limitmay be larger, but never smaller, than the minimum sizespecified for the interconnection in this specification; likewise,a gauge representing a maximum limit may be smaller, butnever larger, than the maximum size specified for the intercon-nection

12、in this specification.6. Keywords6.1 instrument; interconnection; square drive; surgical1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edit

13、ion approved Sept. 1, 2006. Published September 2006. Originallyapproved in 2000. Last previous edition approved in 2000 as F 2062 00.2For referenced ASTM standards, visit the ASTM website, www.astm.org, orcontact ASTM Customer Service at serviceastm.org. For Annual Book of ASTMStandards volume info

14、rmation, 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 Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,

15、 United States.TABLE 1 Square Drive SpecificationsFemale End, mmDrive Size A (square) B D (Note 3) E (Note 2) F (diameter) G (radius)mm in. max min min max min min max min max min4.76 0.1875 4.88 4.80 6.68 3.30 3.05 1.98 6.25 6.15 1.32 1.076.35 0.2500 6.48 6.38 8.51 3.94 3.43 2.29 7.75 7.49 1.73 1.4

16、79.53 0.3750 9.70 9.60 13.13 5.84 5.33 4.32 10.92 10.41 2.41 2.16TABLE 2 Square Drive SpecificationsFemale End, in.Drive Size A (square) B D (Note 3) E (Note 2) F (diameter) G (radius)in. mm max min min max min min max min max min0.1875 4.76 0.192 0.189 0.263 0.130 0.120 0.078 0.246 0.242 0.052 0.04

17、20.2500 6.35 0.255 0.251 0.335 0.155 0.135 0.090 0.305 0.295 0.068 0.0580.3750 9.53 0.382 0.378 0.517 0.230 0.210 0.170 0.430 0.410 0.095 0.085F 2062 00 (2006)2TABLE 3 Square Drive Gauge SpecificationsFemale End, mmDriveSz A1A2B1B2C1C2Gmm in. +0.005 +0.000 +0.005 +0.038 +0.005 +0.000 min0.000 0.005

18、0.005 0.038 0.000 0.0054.76 0.1875 4.801 4.877 6.680 6.553 6.350 6.604 1.9816.35 0.2500 6.375 6.477 8.509 8.331 7.366 7.874 2.2869.53 0.3750 9.601 9.703 13.132 13.005 10.592 11.100 4.318TABLE 4 Square Drive Gauge SpecificationsFemale End, in.DriveSz A1A2B1B2C1C2Gmm in. +0.0002 +0.0000 +0.0002 +0.001

19、5 +0.0002 +0.0000 min0.0000 0.0002 0.0002 0.0015 0.0000 0.00020.1875 4.76 0.1890 0.1920 0.2630 0.2580 0.2500 0.2600 0.07800.2500 6.35 0.2510 0.2550 0.3350 0.3280 0.2900 0.3100 0.9000.3750 9.53 0.3780 0.3820 0.5170 0.5120 0.4170 0.4370 0.1700F 2062 00 (2006)3TABLE 5 Square Drive SpecificationsMale En

20、d, mmDrive Size A (square) B (dia) C D (Note 1) E F (lock height) G (radius) Hmm in. max min 60.002 max min max min min max min max min max4.76 0.1875 4.75 4.70 6.35 6.60 6.35 3.43 3.18 5.33 5.59 5.33 1.30 1.17 4.506.35 0.2500 6.35 6.30 7.92 7.87 7.37 4.19 3.81 6.86 7.36 6.86 1.70 1.57 6.109.53 0.37

21、50 9.53 9.45 12.70 11.10 10.59 5.56 5.44 10.34 10.97 10.34 2.49 2.36 9.27TABLE 6 Square Drive SpecificationsMale End, in.Drive Size A (square) B (dia) C D (Note 1) E F (lock height) G (radius) Hin. mm max min 60.002 max min max min min max min max min max0.1875 4.76 0.187 0.185 0.250 0.260 0.250 0.1

22、35 0.125 0.210 0.220 0.210 0.051 0.046 0.1770.2500 6.35 0.250 0.248 0.312 0.310 0.290 0.165 0.150 0.270 0.290 0.270 0.067 0.062 0.2400.3750 9.53 0.375 0.372 0.500 0.437 0.417 0.219 0.214 0.407 0.432 0.407 0.098 0.093 0.365F 2062 00 (2006)4APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The objec

23、tive of this specification is the provision ofguidelines for the physical characteristics of square driveinterconnections specifically used for medical device applica-tions. This specification identifies those factors felt to beimportant to ensure compatibility of square drive interconnec-tions made

24、 by various manufacturers.X1.2 Not all stainless steels listed in Specification F 899may be appropriate for this application.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 ex

25、pressly 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 the responsible technical committee and must be reviewed every five years andif not revi

26、sed, 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 receive careful consideration at a meeting of theresponsible technical committee, which you ma

27、y 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 International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United Sta

28、tes. 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 through the ASTM website(www.astm.org).TABLE 7 Square Drive Gauge SpecificationsMale End, mmDri

29、ve Size A1 A2 B1 C1 C2 Gmm in. +0.005 +0.000 min +0.005 +0.000 min0.000 0.005 0.000 0.0054.76 0.1875 4.750 4.699 6.680 6.350 6.604 1.9816.35 0.2500 6.350 6.299 8.509 7.366 7.874 2.2869.53 0.3750 9.525 9.449 13.132 10.592 11.100 4.318TABLE 8 Square Drive Gauge SpecificationsMale End, in.Drive Size A1 A2 B C1 C2 Gmm in. +0.0002 +0.0000 min +0.0002 +0.0000 min0.0000 0.0002 0.0000 0.00020.1875 4.76 0.1870 0.1850 0.2630 0.2500 0.2600 0.07800.2500 6.35 0.2500 0.2480 0.3350 0.2900 0.3100 0.09000.3750 9.53 0.3750 0.3720 0.5170 0.4170 0.4370 0.1700F 2062 00 (2006)5