ISO 04865-1-2023.docx

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1、INTERNATIONA1.STANDARDISO4865-1editionFirst2023-10DentistryGenera1.requirementsofhandinstruments一N歌也ingedhandinstrumentsMedecinehuccodentaireExigencesgeneratesre1.ativesauxinstrumentsamain一Partie1:Instrumentsamainnonarticu1.esReferencenumberISO4865-1.:2023(E)COPYRIGHTPROTECTEDDOCUMENTISO2023IUirhM*h

2、edbdi1.iUedotherwiseupdhi.or啪UIBndttaeDmkfifiHipB1.andonnet8CH-1214Vernier,GenevaPhone：M1.22749O1.11觥ftte:丽丽BQrgPub1.ishedinSwitzer1.andContentsForewordivIntroductionv2 Scope13 Normativereferences14 Termsanddefinitions1Requirements24.14.2Materia1.s2Hand1.e2Surfacefinish4.34.54.6Dimensions2Resistance

3、againstreprocessing2VickersandRockwe1.1.hardness2Measurementsandtestmethod35.1 Visua1.inspection35.2 Dimensions35.3 HiCk5t311H精RafaWeHre35.5 Tensi1.etest45.5.1 Princip1.e445.5.4Expressionofresu1.ts.45.6Torquetest45.6.1Princip1.e5.6.2Apparatus4A5.6.3 Procedure5.6.4 Expressionofresu1.ts.44Marking,1.ab

4、e1.1.ingandpackaging46.1Gcnc31Ri)tRvcekcWMpbBr)gbody1.1.tHrwtttti1.6tanddiif(JTOWhidr1.arrtedmitteehasbeenestab1.ishedhastherighttoberepresentedonthatcommittee.Internationa1.organizations,governmenta1.andnon-governmenta1.,in1.iaisonwithISO.a1.sotakepartinthework.ISOco1.1.aboratesc1.ose1.ywiththee1.e

5、ctrotechnica1.standardization.Internationa1.E1.ectrotechnica1.Commission(IEC)ona1.1.mattersofTheproceduresusedtodeve1.opthisdocumentandthoseintendedforitsfurthermaintenanceare蜩则搬OfISO雇哪即es,sR8Ctn怖鞭褊蝴源蒯螂幽抑e%0sanceJ做theeditoria1.ru1.esoftheISO/IECDirectives.Part2(seewww.iso.org/direc1.ives).假)(徽ents)a

6、WNWontakest三嬲据i帆n曲1.fiB幽硼8硒部幽曲野榴IVQdaimedpatentrightsinrespectthereof.Asofthedateofpub1.icationofthisdocumentISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimp1.ementthisdocument.However,imp1.ementersare懈怖翻琳躺nWww.isoQFg/呻ents快t三曲幅ion,扁MMSPOn畅i施蝴睢弓确限照orasuchpatentrights.Anytradeusedinthisco

7、nstitutenameendorsenent.documentisinformationgivenfortheconvenienceofusersanddoesnotForanexp1.anationofthevo1.untarynatureofstandards,themeaningofISOspecifictermsand幽幽蛔豳酒侬遮W即辆O)assEif1.眦聚inwe帼1.见OnBarRWyE辟dead邮&CcsVbu11uisobrgiso/foreword.htmI.於眼三三IO谖瞪囤刚靓榭隰神翩itm%itJ觎相晚观dardi阑源UbCO1.ftteeechnica1.Con

8、imit1.ecCEN/TC55,Dentistry,inaccordancewiththeAgreementontechnica1.cooperationbetweenISOandCEN(ViennaAgreement).IntroductionNon-hingedhandinstrumentsusedindentistrysharemanycommoncharacteristicsinc1.udingmateria1.POtMipwtirssejqn11fiBfcsfc.ntsthfenerepreat1.pgi)Dehpitevarthtionnanyth11pdiihf1.drequi

9、f!11ffQtHidifIerentmethods.Thisdocumentaddressesthesecommoncharacteristicsandprovidesanormativereferencetohe1.preducevariationandto1.eadtoaharmonizationofstandardsfornon-hingedhandinstruments.DentistryGenera1.requirementsofhandinstruments一Non-hingedhandinstruments1 Scopeinformationdentistry,inc1.udi

10、nga1.thoughmateria1.s,hardness.additiona1.specificrequirementsreprocessingandinstruments.2 Normativereferencesconstitutesrequirements1.atestcditiondocument.rcfcrencedreferences.(inc1.udingamendments)app1.ies.app1.ies.ISO6507-1.rMeta1.1.icmateria1.sVickershardnesstestPart1:TestmethodISO15223-1,Medica

11、1.requirementsSymbo1.stobeusedwithinformationtobesupp1.iedbythemanufacturermanufacturerfortheprocessingofmedica1.devicesPan1：Critica1.andsemi-critica1.medica1.devicesmanufacturerfortheprocessingofmedica1.devices-Pan2：Non-critica1.medica1.devices3 TermsanddefinitionsISOandIECmaintaintermino1.ogydatab

12、asesforuseinstandardizationa1.thefo1.1.owingaddresses：3.1 IECE1.ectropedia:avai1.ab1.eathtsiwww.e1.eropedia.orgnon-hingedhandinstrumentPart1:Thisdocumentspecifiesrequirementsand1.estmethodscommontoa1.1.nonhingedhandinstrumentsusedformarking,somecanhavesurfacefinish,resistancetoandtestmet1.ods.Thisdo

13、cumentdoesnotspecifytermsanddefinitionsorc1.assificationofspecifictypesofhandThisdocumentexc1.udespoweredinstruments.Thec1.assicationandtheshapeofworkingendsofnon-hingedhandinstrumentsareexc1.udedfromthisdocument.Thefo1.1.owingdocumentsarereferredtointhetextinsuchawaythatsomeora1.1.oftheircontentund

14、atedreferences,theofthisoftheFordateddocumenton1.ytheanyeditioncitedForISO1942,DentistryVocabu1.aryISO6508-1:2016,Meta1.1.icmateria1.sRockwe1.1.hardnesstestPart1:Testmethod一Part1：Genera1.devices一ISO17664-1,Processingofhea1.thcareproductsInformationtobeprovidedbythemedica1.deviceISO17664-2,Processing

15、ofhea1.thcareproductsInformationtoheprovidedbythemedica1.deviceISO20417fMedica1.devicesInformationtobesupp1.iedbythemanufacturerForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO1942andthefo1.1.owingapp1.y.ISOOn1.inebrowsingp1.atform:avai1.ab1.eathttps:/www.iso.org/obprigidmanua1.denta1.d

16、evicewithoutahingedpart(non-hinged),havingasing1.eordoub1.eworkingend三anUMt4Requirements4.1 Materia1.sThemateria1.susedforboththehand1.eandtheworkingtipareatthemanufacturersdiscretionprom0teiatsuthb1.certbypanc0ndfofri33inntxi)rdancadSWUh)6i3,cc)ntainmentwithina4.5ResistanceagainstreprocessingThenon

17、-hingedhandinstrumentstobeusedIife-Iongrsha1.1.withstand100reprocessingcyc1.es,astieftnedacbgiVhinceinsEi&ifensftn1.保M3加W8也IiaimatiOnStamd加HvAI网叩日出呻讪amjIMiCNmR1.hhVsha1.1.meetequiw?RWM1.tSStaUM1.in4.6,4.7and4.8fo1.1.owingthe100reprocessingcyc1.esandtestinaccordanceto5.4,5.5and5.6.4.6 VickersandRockw

18、e1.1.hardnessThehardnessoftheworkingpartofnon-hingedhandinstrumentssha1.1.bes1.atedineitherVickersorRockwe1.1.hardness.Thehardnessfortheworkingpartsofnon-hingedhandinstumentssha1.1.beinaccordancewiththerequirementsstatedintherespectiveInternationa1.Standardfortheindividua1.instrument.IbtbArmen(P则而或醐

19、IhabdrW曲tatdWpfhethe丽e如UgHmiOnaEMrtddmhurer.fortheindividua1.Testinaccordanceto5.4.4.7 Tensi1.estrengthTheconnectionbetweenworkingendandhand1.eofthenon-hingedhandinstrumentssha1.1.not1.ooseni11BirMtm0est1.rti1.ettnengthstntHiitteordawjectiveInternationa1.Standardfortheindividua1.4.8 TorquestrengthTh

20、econnectionbetweenworkingendandhand1.eofthenon-hingedhandinstrumentssha1.1.not1.ooseniuhtmHwbjtcIWttdihturqueinacvohdaHtatedih1.fi(frespectivcInternationa1.Standardfortheindividua1.5Measurementsandtestmethod5.1 Visua1.inspectionConductvisua1.inspectionatnorma1.visua1.acuitywithoutmagnification.5.2 D

21、imensionsMeasurethedimensionsusingameasuringdevicethatisaccurateto1/10Oftheto1.erancetobemeasured.Resistanceagainstreprocessing5.3PURRQCa1.rePr。通。Q51W1.t1entSH况MY解新Ri密比布&般amdefhtet1.ft师旬印IWKtrUCdonSforuse.Thereprocessingcyc1.esha1.1.inc1.udethemanufacturersrecommendedmethodsofc1.eaning,disinfection,

22、andsteri1.ization,inaccordancewithISO17664-1.Ifthemanufacturerhasspecified泮热精8Rhc三%MdcyMaWdkfi%1.WsRM1qa1.1.coPFtf8f1.surfaUFJnIn胴E6yfc51.用QSteri1.陪神居I8UIfiIVqFe带盟际dinginfor野夕感舐：dingmanua1.orautomatedc1.eaningmethodsForsemi-critica1.instrumentsthatwi1.1.bereprocessedusingva1.idatedhigh-1.eve1.therma

23、1.orchemica1.H1.gWteferV%utWreprocessingCXdeSShaHWithind拙，呻仙柚蹴(曲斗乩融V踞僧三报眼c1.eaninganddisn1.cctioninaccordanceWifhISO176641.Ifthemanufacturerhasspecifiedanaxunu11numberofcyc1.es1.essthan100,thisnumbersha1.1.beusedforthetest.Inspecta1.1.ofthesurfacesofthenon-hingedhandinstrumentsforanysignsofcorrosion

24、surfacedefectinaccordanceto-4-.Fornon-critic1.instrumentsthatdonotrequiresteri1.izationorhigh-1.eve1.disinfection,carryout100c1.eaninganddisinfectioncyc1.eswiththenon-hingedhandinstruments,asdefinedbytheinstructionstoSiWfcSbfi管隰Pf啾机,tHSnufacturer!recom舐棚即由e1.脚加脸1瓯nin蒯冲erofcyc1.es1.essthan100,thisnum

25、bersha1.1.beusedforthetest.Inspecta1.1.ofthesudacesofthenon-hingedhandinstrumentsforanysignsofcorrosion/surfacedefectinaccordanceto5.1.姬丽丽帆沃扬济强1.i&脚岫电电用解僧fc面顿ft6的锦期展碗时峭的的能da觥Mu依esfami1.yaccordingtoISO17664-1andISO17664-2.Carryoutteststatedin5.4,5.5and5.6afterthereprocessingcyc1.es.S1.#1.Zicken&and-a

26、tioniRockwe1.1.hardnessarenotsignsofcorrosion.TesttheVickershardnessinaccordancewithISO6507-1.TesttheRockre1.1.hardnessinaccordancewithISO6508-1:2016,C1.assCrrespective1.y.5.5 Tensi1.etest5.5.1 Princip1.eThetestoftensi1.estrengthofconnectionbetweenhand1.eandtheworkingpartisperformedbymeasuringthemax

27、imumtensi1.estrengthwhenpu1.1.edfromeachend.5.5.2 ApparatusApparatusfortensi1.estrengthtest,suchasauniversa1.testingmachinethatiscapab1.eofpu1.1.ingtestsamp1.eat0,5mm/minwhi1.emeasuringtheapp1.iedtensi1.e1.oad.5.5.3 ProcedureConnectthehand1.eandtheworkingendsecure1.ytoeachpartofthejigconnectedtotens

28、i1.estrengthInQSbtwdfcohkmrcrsa1.jMrinBecOrHmaChinM喇StIWfmtbQdd印(f1.uniWa5dniurtiihrhd1.dbda1.uringthetestunti1.thepointoffai1.ure.5.5.4 Expressionofresu1.tsExpressthemaximumtensi1.e1.oadinnewton(N).5.6 Torquetest5.6.1 Princip1.eThetestOfresistancetotorqueonconnectionbetweenhand1.eandtheworkingparti

29、sperformedbymeasuringthemaximumtorqueva1.uewhenhand1.eandworkingpartistwistedindifferentdirections.5.6.2 ApparatusApparatusfortorquetest,suchastorquemeterthatiscapab1.eoftwistingasamp1.eatonerotationperminutewhi1.emeasuringapp1.iedtorqueforce.5.6.3 ProcedureConnectthehand1.eandtheworkingendsecure1.y

30、toeachpartoftheigconnectedtotorquecontro1.tiw)chmainOrRf0ti(AppfiaxmA(npiato1.vataatdu11ngfatu11tbnti1.ttntiih11diai5ffai1.ure.1.oosenfrom5.6.4 Expressionofresu1.tsExpressthemaximumtorqueva1.ueinnewtonmeter(Nm).6Marking,Iabe1.1.ingandpackaging6.1 Genera1.Genera1.informationformarking,1.abe1.1.ingand

31、packagingsha1.1.beinaccordancewithISO20417.6.2 MarkingNon-hingedhandinstrumentssha1.1.bemarkedasfo1.1.ows:b) mode1.number(referencenumber)；c) 1.otnumber(batchdesignation)orUD1.-code(uniquedeviceidentification),asrequiredincountryofsa1.e.PRb1.et1.hCNfhHU:fo*Ubd.SymbO1.forSteri1.izah1.einasteamsteri1.

32、izergiveninISO21531:2009,6.31.abe1.1.ing1.abe1.1.ingonthepackagesha1.1.usegraphica1.symbo1.sinaccordancewithISO15223-1.1.abe1.1.ingonthepackagesha1.1.inc1.ude：a) nameandaddressofthemanufacturer;b) mode1.number(referencenumber);c) 1.otnumber(batchdesignation);7) IntfCtt)1.81fWt,Mfieidentification),as

33、requiredinthecountryofsa1.e.Instructionsforusesha1.1.inc1.ude：a) genera1.information(nameofthemanufacturer,productdescription)；b) indicationsforuse：c) contraindicationsforuse；d) warnings；e) precautionsforspecia1.hand1.ing;0knownadversereactions;g) reprocessingmethoddescribedinaccordanceWithISO17664-

34、1orISO17664-2,Inc1.udingc1.eaning,disinfection,steri1.izationandpackaging/storage;h) dateofissueorrevisionversion.Ifgraphica1.symbo1.sareusedwhicharenotinaccordancewithISO15223-1,theysha1.1.beexp1.ainedintheinstructionsforuse.Instructionsmanufacturer.forusecanbemadeaccessib1.einpaperore1.ectronicformonthehomepageoftheBib1.iography(1 ISO21531:2009,DentistryGraphica1.symbo1.sfordenta1.instruments(2 ISO21850-1,DentistryMateria1.sfordenta1.instrumentsPart1:Stain1.essstee1.