BS EN ISO 15098-1-2001 Dental tweezers - General requirements《牙科镊子 一般要》.pdf

1、BRITISH STANDARD BS EN ISO 15098-1:2001 Dental tweezers Part 1: General requirements The European Standard EN ISO 15098-1:2001 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN ISO 15098-1:2001 This British Standard, having

2、 been prepared under the direction of the Health and Environment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 July 2001 BSI 07-2001 ISBN 0 580 37005 4 National foreword This British Standard is the English language version of EN ISO 15098

3、-1:2001. It is identical with ISO 15098-1:1999. The UK participation in its preparation was entrusted to Technical Committee CH/52, Dental instruments, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references

4、 Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their corresponding European publications. The British Standards which implement these international or European publications may be found in t

5、he BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are r

6、esponsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and

7、keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page, the ISO title page, pages ii and iii, a blank page, p

8、ages 1 to 7, the annex ZA page, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO150981 March2001 ICS11

9、.060.20 Englishversion DentaltweezersPart1:Generalrequirements(ISO15098 1:2000) PrcellesdentairesPartie1:Exigencesgnrales(ISO 150981:2000) ZahnrztlichePinzettenTeil1:AllgemeineAnforderungen (ISO150981:2000) ThisEuropeanStandardwasapprovedbyCENon21December2000. CENmembersareboundtocomplywiththeCEN/CE

10、NELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEuropeanStandardexistsinth

11、reeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,

12、France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2001CEN Allrightsofexploitationinan

13、yformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO150981:2001EgaPe2 INES89051O1:1002 Foreword ThetextoftheInternationalStandardfromTechnicalCommitteeISO/TC106“Dentistry“of theInternationalOrganizationforStandardization(ISO)hasbeentakenoverasanEuropean StandardbyTechnicalCommitte

14、eCEN/TC55“Dentistry“,thesecretariatofwhichisheldby DIN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublication ofanidenticaltextorbyendorsement,atthelatestbySeptember2001,andconflicting nationalstandardsshallbewithdrawnatthelatestbySeptember2001. ENISO15098consistsofthefoll

15、owingparts,underthegeneraltitle DentalTweezers : Part1:Generalrequirements Part2:Meriamtypes Part3:Collegetypes AnnexesAandBofthispartofENISO15098areforinformationonly. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEurope

16、anStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited Kingdom. Endorsementnotice ThetextoftheInternationalStandardISO150981:1999 hasbeenapprovedbyCENasa EuropeanStandardwithou

17、tanymodification. NOTE:NormativereferencestoInternationalStandardsarelistedinannexZA(normative). ENISO150981:2001 A Referencenumbe r ISO150981:1999 (E) INTERNATIONAL STANDARD ISO 150981 Firstedition 19991015 Dentaltweezers Part1: Generalrequirements Prcellesdentaires Partie1:Exigencesgnrales ENISO15

18、0981:2001 )E(9991:189051OSI ii Contents 1Scop e1 2Normativereference s1 3Termsanddefinition s.1 4Materia l.1 5Requirement s.2 6Testmethods. .2 7Markin g.3 AnnexA (informative) Measurementofdimension s4 AnnexB (informative) Vickershardnesstestin g6 ENISO150981:2001 OSI )E(9991:189051OSI iii Foreword

19、ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISO memberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnical committees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhas therightt

20、oberepresentedonthatcommittee.Internationalorganizations,governmentalandnongovernmental,in liaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnical Commission(IEC)onallmattersofelectrotechnicalstandardization. InternationalStandardsaredraftedinaccordancewiththe

21、rulesgivenintheISO/IECDirectives,Part3. DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting. PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote. InternationalStandardISO150981waspreparedbyTechnicalCommitteeISO/T

22、C106, Dentistry,Subcommittee SC4, Dentalinstruments . ISO15098consistsofthefollowingparts,underthegeneraltitle Dentaltweezers : Part1:Generalrequirements Part2:Meriamtypes Part3:Collegetypes AnnexesAandBofthispartofISO15098areforinformationonly. ENISO150981:2001 ENISO150981:2001 DRADNATSLANOITANRETN

23、I ISO )E(9991:189051OSI 1 Dentaltweezers Part1: Generalrequirements 1Scope ThispartofISO15098specifiesgeneralmaterialandperformancerequirementsformetaldentaltweezers. 2Normative references Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsof thispart

24、ofISO15098.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublications donotapply.However,partiestoagreementsbasedonthispartofISO15098areencouragedtoinvestigatethe possibilityofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.Forundated references,thelatesteditio

25、nofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintain registersofcurrentlyvalidInternationalStandards. ISO19423, DentalvocabularyPart3:Dentalinstruments. ISO65071, MetallicmaterialsVickershardnesstestPart1:Testmethod . ISO71531, SurgicalinstrumentsMetallicmaterialsPart1:Stainlesssteel

26、. ISO13402, SurgicalanddentalhandinstrumentsDeterminationofresistanceagainstautoclaving,corrosionand thermalexposure . 3 Termsanddefinitions ForthepurposesofthispartofISO15098,thetermsanddefinitionsgiveninISO19423apply. 4Material TheworkingendshallbemadeofmartensiticstainlesssteelofgradeB,C,DorRorau

27、steniticstainlesssteel, complyingwithISO71531,orothermaterialsprovidingtheinstrumentmadetherefrommeetstherequirementsof clause5. ENISO150981:2001 )E(9991:189051OSI OSI 2 5Requirements 5.1 Maximumoveralllength UnlessspecifiedinotherpartsofISO15098,themaximumoveralllengthofdentaltweezersshallbe178mm.

28、AnnexAprovidesdetailsofonemethodofmeasurementapplicabletomosttypesofdentaltweezers. 5.2 Vickershardnessoftheworkingend TheVickershardnessoftheworkingendofthefinishedinstrument,whentestedinaccordancewithISO65071, shallbewithintherange390HV1to550HV1. AnnexBprovidesdetailsofamethodformeasuringtheVicker

29、shardness. 5.3Surface finish 5.3.1All surfaces Allsurfacesshallbevisiblyfreefrompores,crevices,grindingmarks,residualscales,acid,greaseandresidual grindingandpolishingmaterials,wheninspectedusingnormalvision. 5.3.2Satin finish Anysatinfinishshallbebothuniformandsmooth,anditshallreduceglare. 5.3.3Mir

30、ror finish Anymirrorfinishshallbegroundtoremoveallsurfaceimperfectionsandpolishedtoremovegrindingmarks, resultinginahighlyreflectivesurface. 5.4 Resistanceagainstcorrosion Whentestedforresistancetoautoclavingorboilingwaterinaccordancewith6.2or6.3,thetweezersshallexhibit novisiblesignsofcorrosion. 5.

31、5 Resistanceagainstthermalexposure Whentestedforresistanceagainstthermalexposureinaccordancewith6.3,thetweezersshallexhibitnovisible signsofalteration.TheVickershardnessafterthermalexposureshallremainwithinthestipulatedhardnessrange. 6Test methods 6.1 Testsequenceandcycles Carryoutoneofthefollowingt

32、estalternativesinonecontinousoperationforfivecycles: a) autoclavetestor b) boilingwatertestandthermalexposuretest. Aftercompletingthetestsequence(6.2or6.3),rubtheinstrumentvigorouslywithaclothtoremoveblemishes. 6.2Autoclave test CarryouttheautoclavetestasspecifiedinISO13402. ENISO150981:2001 OSI )E(

33、9991:189051OSI 3 6.3 Boilingwatertestandthermalexposuretest CarryoutboththeboilingwatertestandthethermalexposuretestasspecifiedinISO13402. 7Marking Theinstrumentshallbeindeliblymarkedwiththefollowinginformation: a) manufacturersnameortradename; b) patternnumberorname; c)lot number. ENISO150981:2001

34、)E(9991:189051OSI OSI 4 AnnexA (informative) Measurementofdimensions A.1General Thismethodofmeasurementisapplicabletomosttypesofdentalhandinstrumentandisbasedontheuseofan opticalprojector.Dimensionsaremeasuredparallel,andatrightangles,tothecentrelineoftheinstrumentandare constructedfromadatumpointat

35、itsworkingend. Althoughthisisthepreferredmethod,itisbynomeanstheonlytechniqueavailable. A.2Apparatus A.2.1 Opticalprojector (shadowgraph) fittedwitha10 3magnifyinglensandmicrometerstage . A.2.2 Glassspecimenslideandplasticine, or A.2.3 Mechanicalholdingdevice (e.g.lightmachinevice),or A.2.4 Vblock.

36、A.3Procedure A.3.1Preparationformeasurement A.3.1.1 SupportorholdthedentalinstrumentusingoneofthedevicesinA.2.2,A.2.3orA.2.4. A.3.1.2 Placethesupportedinstrumentonthemicrometerstageoftheprojector(A.2.1)andensurethatthe followingrequirementsaremet: a) theworkingendoftheinstrumentprojectsbeyondthehold

37、ingdevice; b) theinstrumentissecurelyheld; c) thereisanunobstructedviewoftheworkingend. A.3.1.3 Ensurethatthedentalinstrumentisparalleltothemicrometerstagebyfocusingon,andtraversingthe lengthof,thehandle.Ifthehandleremainsinfocusoverthetraverseddistance,thentheinstrumentisreadyfor measurement. Ifthe

38、handledoesnotremaininfocus,repeatA.3.1.2andA.3.1.3untilthehandleremainsinfocusthroughthefield oftraverse. A.3.1.4 Alignthecentrelineofthedentalinstrumentwiththeverticalorhorizontalcrosswiresontheprojector screen. ENISO150981:2001 OSI )E(9991:189051OSI 5 A.3.2Horizontalandverticalmeasurements A.3.2.1

39、 Refertotheillustration,tableofdimensionsandtableofmeasurementpointsrelatedtotheinstrumentto bemeasuredand,usingthemicrometerstage,bringtheappropriatepointoftheprojectedimagetoeitherthe verticalorhorizontalcrosswire,whicheverisappropriatetothedatummeasuringpointofinterest. A.3.2.2 Zerothemicrometera

40、ndmovethemicrometerstagetothefinalmeasurementpositionandrecordthe measurement. A.3.2.3 Realigntheinstrument(A.3.1.4)andrepeatstepsA.3.2.1andA.3.2.2fortheremainingdimensions. A.3.3Angularmeasurements A.3.3.1 Refertotheillustration,tableofdimensionsandtableofmeasurementpointsrelatedtotheinstrumentto b

41、emeasuredand,usingthemicrometerstage,bringtheappropriatepointoftheprojectedimagetoeitherthe verticalorhorizontalcrosswire,whicheverisappropriate. A.3.3.2 Rotatethebezeloftheprojectorscreentothedatummeasuringpointandnotetheangularreading. A.3.3.3 Rotatethebezeltothefinalmeasurementposition,subtractth

42、einitialangularreadingfromthefinal readingandrecordthemeasuredangle. ENISO150981:2001 )E(9991:189051OSI OSI 6 AnnexB (informative) Vickershardnesstesting B.1General Themethoddescribedhereinisapplicabletomosttypesofdentalinstrumentandisbasedonapplyinga1kgload, viaa136diamondindentor,totheworkingendof

43、theinstrument. NOTE Itmaybenecessarytoencapsulatetheworkingendsofcertaindentalinstrumentsinaplasticmountingmediumin ordertoachievethisobjective. ISO65071shallberegardedasthereferencetestmethod. B.2Apparatus B.2.1 Vickershardnesstestingmachine. B.2.2 Mass of1kg. B.2.3 Setoftables forconvertingocularreadingtoVickershardnessvalues. B.2.4 Finefile. B.2.5 Machinevice. B.2.6 Siliconcarbideabrasivepapers ,ofgrades180,320,400and600. B.3Preparation B.3.1Forlarger,robustdentalinstruments a) Prepareaflatareaontheworkingendoftheinstrumentusingafinefileandwip