ASTM_F_2062_-_00_2018.pdf

Designation:F206200(Reapproved 2018)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 year 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 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 industrialapplications 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 injure 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.Combiningvalues from the two systems may result in non-conformancewith the standard.1.5 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.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 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,pushing,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 apply only to stainlesssteel instruments that conform to Specification F899.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 notintended 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 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 specification.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 in this specification.1This 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 edition approved Oct.1,2018.Published November 2018.Originallyapproved in 2000.Last previous edition approved in 2011 as F2062 00(2011).DOI:10.1520/F206200R18.2For 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.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 6.Keywords6.1 instrument;interconnection;square drive;surg