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,Processingofhea1.thcare