ASTM F2062-2000(2011) Standard Specification for Square Drive Interconnections on Surgical Instruments《外科用设备中正方操作面操作互相联络标准规范》.pdf

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1、Designation: F2062 00 (Reapproved 2011)Standard Specification forSquare Drive Interconnections on Surgical Instruments1This standard is issued under the fixed designation F2062; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the y

2、ear of last revision. A number 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 applies to interconnections of surgicalinstruments used for drilling, tapping, driving, or p

3、lacing 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 indu

4、strialapplications 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 injur

5、e thepatient or end user, or damage or contaminate the instrument.1.4 The values stated in either SI units or inch-pound unitsare to be regarded separately as standard. The values stated ineach system may not be exact equivalents; therefore, eachsystem shall be used independently of the other. Combi

6、ningvalues from the two systems may result in non-conformancewith the standard.2. Referenced Documents2.1 ASTM Standards:2F899 Specification for Wrought Stainless Steels for SurgicalInstruments2.2 Other Standard:ASME B107.4M-1995 (Revision of ANSI B107.4-1982),Driving and Spindle Ends for Portable H

7、and, 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, pushing, or pulling asurgical instrument to place a medical device during surgery.3.1.3 square drive

8、a 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 apply only to stainlesssteel instruments that conform to Specification F899. If othertypes of mat

9、erials 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 notintended to preclude the manufacture of product or gaugeswhich are otherwise in accordance with this sp

10、ecification.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 extreme limits of interconnections speci-fied within this specification. All variations (manufa

11、cturingtolerance, 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 specification. Thus, a gauge representing a minimum limitmay be larger, but never smaller, than the m

12、inimum 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 in this specification.6. Keywords6.1 instrument; interconnection; square drive; surgical1This sp

13、ecification 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 InstrumentsCurrent edition approved June 1, 2011. Published July 2011. Originally approvedin 2000. Last previous edition

14、 approved in 2006 as F2062 00(2006). DOI:10.1520/F206200R11.2For 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.3

15、Available 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, United States.TABLE 1 Square Drive SpecificationsFemale End, mmDrive Size

16、 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 1.479.53 0.3750 9.70 9.60 13.13 5.84 5.33 4.32 10.92 10.41 2.41 2.16TABLE 2 S

17、quare 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 0.0420.2500 6.35 0.255 0.251 0.335 0.155 0.135 0.090 0.305 0.295 0.068 0.0580.

18、3750 9.53 0.382 0.378 0.517 0.230 0.210 0.170 0.430 0.410 0.095 0.085F2062 00 (2011)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 0.005 0.038 0.000 0.0054.76 0.1875 4.801 4.877 6.680 6.553 6.350 6.604 1.98

19、16.35 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 +0.0015 +0.0002 +0.0000 min0.0000 0.0002 0.0002 0.0015 0.0000 0.00020.1875 4.76 0

20、.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 0.1700F2062 00 (2011)3TABLE 5 Square Drive SpecificationsMale End, mmDrive Size A (square) B (dia) C D (Note 1) E F (lock height) G (radius)

21、 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 0.3750 9.53 9.45 12.70 11.10 10.59 5.56 5.44 10.34 10.97 10.34 2.49 2.36 9.27TAB

22、LE 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 0.135 0.125 0.210 0.220 0.210 0.051 0.046 0.1770.2500 6.35 0.250 0.248 0.312 0.

23、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 0.365F2062 00 (2011)4APPENDIX(Nonmandatory Information)X1. RATIONALEX1.1 The objective of this specification is the provision ofguidelines for the physical cha

24、racteristics 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 by various manufacturers.X1.2 Not all stainless steels listed in Specificati

25、on F899may be appropriate for this application.TABLE 7 Square Drive Gauge SpecificationsMale End, mmDrive 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.

26、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 0.09000.375

27、0 9.53 0.3750 0.3720 0.5170 0.4170 0.4370 0.1700F2062 00 (2011)5ASTM 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 suc

28、h 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 revised, either reapproved or withdrawn. Your comments are invite

29、d 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 may attend. If you feel that your comments have not received a

30、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 States. Individual reprints (single or multiple copies) of this

31、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). Permission rights to photocopy the standard may also be secured from the ASTM website (www.astm.org/COPYRIGHT/).F2062 00 (2011)6