BS EN ISO 15087-1-2001 Dental elevators - General requirements《牙科起子 一般要求》.pdf

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1、BRITISH STANDARD BS EN ISO 15087-1:2001 Incorporating Corrigendum No. 1 Dental elevators Part 1: General requirements The European Standard EN ISO 15087-1:2001 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBS EN ISO 15087-1:2

2、001 This British Standard, having been prepared under the direction of the Health and Environmental Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 18 September 2001 BSI 29 January 2002 ISBN 0 580 38058 0 National foreword Thi

3、s British Standard is the official English language version of EN ISO 15087-1:2001. It is identical with ISO 15087-1:1999. 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 t

4、his committee can be obtained on request to its secretary. Cross-references The British Standards which implement international or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”,

5、 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 responsible for their correct application. Compliance with a British Standard does not of itself confe

6、r 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 keep the UK interests informed; monitor related international and European developments and promulgat

7、e 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, pages 1 to 11, the Annex ZA page, an inside back cover and a back cover. The BSI copyright date displa

8、yed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date Comments 13635 Incorporating Corrigendum No. 1 29 January 2002 Corrected the EN ISO foreword page and inserted the Annex ZA page.EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO150

9、871 August2001 ICS11.060.20 Englishversion DentalelevatorsPart1:Generalrequirements(ISO15087 1:1999) ElvateursdentairesPartie1:Exigencesgnrales(ISO 150871:1999) ZahnrztlicheWurzelheberTeil1:Allgemeine Anforderungen(ISO150871:1999) ThisEuropeanStandardwasapprovedbyCENon11June2001. CENmembersareboundt

10、ocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEurope

11、anStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepub

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

13、tsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO150871:2001ECORRECTED20011205 Foreword ThetextoftheInternationalStandardfromTechnicalCommitteeISO/TC106“Dentistry“of theInternationalOrganizationforStandardization(ISO)hasbeentakenoverasanEuropean StandardbyTe

14、chnicalCommitteeCEN/TC55“Dentistry“,thesecretariatofwhichisheldby DIN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublication ofanidenticaltextorbyendorsement,atthelatestbyFebruary2002,andconflictingnational standardsshallbewithdrawnatthelatestbyFebruary2002. Accordingtothe

15、CEN/CENELECInternalRegulations,thenationalstandardsorganizationsof thefollowingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium, CzechRepublic,Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy, Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandtheUnited King

16、dom. Endorsementnotice ThetextoftheInternationalStandardISO150871:1999hasbeenapprovedbyCENasa EuropeanStandardwithoutanymodification. NOTE:NormativereferencestoInternationalStandardsarelistedinannexZA(normative). ENISO150871:2001 A Referencenumbe r ISO150871:1999 (E) INTERNATIONAL STANDARD ISO 15087

17、1 Firstedition 19991101 Dentalelevators Part1: Generalrequirements lvateursdentaires Partie1:Exigencesgnrales ENISO150871:2001 ii Contents 1Scop e1 2Normativereference s1 3Termsanddefinition s.1 4Classificatio n2 5Materia l.2 6Requirement s.2 7Testmethods. .3 8Markin g.4 AnnexA (informative) Measure

18、mentofdimension s5 AnnexB (informative) Vickershardnesstestin g7 AnnexC (informative) Testundertensileloa d.9 AnnexD (informative) Testundertorqu e10 ENISO150871:2001 iii Foreword ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISO memberbodies).The

19、workofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnical committees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhas therighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnongovernmental,in liaisonwithISO,alsotakepartin

20、thework.ISOcollaboratescloselywiththeInternationalElectrotechnical Commission(IEC)onallmattersofelectrotechnicalstandardization. InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3. DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememb

21、erbodiesforvoting. PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote. InternationalStandardISO150871waspreparedbyTechnicalCommitteeISO/TC106, Dentistry,Subcommittee SC4, Dentalinstruments . ISO15087consistsofthefollowingparts,underthegeneraltitle Dentalele

22、vators : Part1:Generalrequirements Part2:WarwickJameselevators Part3:Cryerelevators Part4:Couplandelevators Part5:Beinelevators Part6:Flohrelevators AnnexesAtoDofthispartofISO15087areforinformationonly. ENISO150871:2001 ENISO150871:2001 DRADNATSLANOITANRETNI OSI )E(9991:178051OSI 1 Dentalelevators P

23、art1: Generalrequirements 1Scope ThispartofISO15087specifiesthegeneralmaterialandperformancerequirementsfordentalelevators. 2Normative references Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsof thispartofISO15087.Fordatedreferences,subsequentame

24、ndmentsto,orrevisionsof,anyofthesepublications donotapply.However,partiestoagreementsbasedonthispartofISO15087areencouragedtoinvestigatethe possibilityofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.Forundated references,thelatesteditionofthenormativedocumentreferredtoapplies.Me

25、mbersofISOandIECmaintain registersofcurrentlyvalidInternationalStandards. ISO19423:1989, DentalvocabularyPart3:Dentalinstruments. ISO2592, PetroleumproductsDeterminationofflashandfirepointsClevelandopencupmethod. ISO3104,PetroleumproductsTransparentandopaqueliquidsDeterminationofkinematicviscosityan

26、d calculationofdynamicviscosity. ISO65071:1997, MetallicmaterialsVickershardnesstestPart1:Testmethod . ISO71531:1991, SurgicalinstrumentsMetallicmaterialsPart1:Stainlesssteel . ISO13402, SurgicalanddentalhandinstrumentsDeterminationofresistanceagainstautoclaving,corrosionand thermalexposure . 3 Term

27、sanddefinitions ForthepurposesofthispartofISO15087,thetermsanddefinitionsgiveninISO19423apply. ENISO150871:2001 )E(9991:178051OSI OSI 2 4Classification DentalelevatorsspecifiedinallpartsofISO15087areclassifiedaccordingtotheVickershardnessoftheworking endintothefollowingclasses: Class1:480HV1to600HV1

28、 Class2:600HV1to720HV1 ThemanufacturershallstatetheVickersclassificationintheproductdocumentation. 5Material 5.1 Materialoftheworkingend TheworkingendshallbemadeofmartensiticstainlesssteelofgradeB,C,DorRcomplyingwithISO71531,or othermaterialsprovidingtheinstrumentmadetherefrommeetstherequirementsofc

29、lause6. 5.2 Materialofthehandle Thematerialofthehandle,selectedatthediscretionofthemanufacturer,shallmeettherequirementsofclause6. 6Requirements 6.1 Maximumoveralllength UnlessotherwisespecifiedinotherpartsofISO15087,themaximumoveralllengthofdentalelevatorsshallbe 178mm. AnnexAprovidesdetailsofoneme

30、thodofmeasurementapplicabletomosttypesofdentalelevators. 6.2 Vickershardnessoftheworkingend TheVickershardnessoftheworkingendofthefinishedinstrument,whentestedinaccordancewithISO65071, shallbewithintherangeofclass1orclass2.Themanufacturershallstatetheappropriatehardnessclassforeach instrumentpattern

31、orrangeofinstrumentsintheproductdocumentation. AnnexBprovidesdetailsofamethodofmeasurementforVickershardness. 6.3Surface finish 6.3.1All surfaces Allsurfacesshallbevisiblyfreefrompores,crevices,grindingmarks,residualscales,acid,greaseandresidual grindingandpolishingmaterials,wheninspectedusingnormal

32、vision. 6.3.2Satin finish Anysatinfinishshallbebothuniformandsmooth,anditshallreduceglare. 6.3.3Mirror finish Anymirrorfinishshallbegroundtoremoveallsurfaceimperfectionsandpolishedtoremovegrindingmarks, resultinginahighlyreflectivesurface. 6.4 Resistanceagainstautoclaving Whentestedinaccordancewith7

33、.2,theinstrumentshallexhibitnovisiblesignsofalteration. ENISO150871:2001 OSI )E(9991:178051OSI 3 6.5 Resistanceagainstcorrosion 6.5.1Working end Whentestedforresistancetoboilingwaterinaccordancewith7.3,theworkingendshallexhibitnovisiblesignsof corrosion. 6.5.2Handle Whentestedforresistancetoboilingw

34、aterinaccordancewith7.3,thehandleshallexhibitnovisiblesignsof corrosion. 6.6 Resistanceagainstthermalexposure Whentestedforresistanceagainstthermalexposureinaccordancewith7.3,theinstrumentshallexhibitnovisible signsofalteration. 6.7 Unionbetweentheworkingendandhandle Theunionbetweentheworkingendandt

35、hehandleoftheinstrument,previouslytestedinaccordancewith6.3to 6.6,shallnotbecomeloosenedundertensileloadwhentestedinaccordancewith7.4.1andundertorquewhen testedinaccordancewith7.4.2. 6.8 Hollowhandleleaktest Whentestedinaccordancewith7.5.1or7.5.2,theinstrumenthandleshallemitnobubbleswhichareasignof

36、leakage. 7Test methods 7.1 Testsequenceandcycles Carryoutoneofthefollowingtestingalternativesinonecontinuousoperationforfivecycles: a) autoclavetestor b) boilingwatertestandthermalexposuretest. Aftercompletingthetest(7.2or7.3),rubtheinstrumentvigorouslywithaclothtoremoveblemishes. NOTE Instrumentswi

37、thhollowhandles,whensubjecttothecombinationofboilingwaterandthermalexposuretests,may rupturefromtheexpansionoftrappedmoisture. 7.2Autoclave test CarryouttheautoclavetestasspecifiedinISO13402. 7.3 Boilingwatertestandthermalexposuretest Carryoutboththeboilingwatertestandthethermalexposuretestasspecifi

38、edinISO13402. 7.4 Testforunionbetweenworkingendandhandle 7.4.1 Testundertensileload Subjecttheunionbetweentheworkingendandthehandletoatensileforceof1000N,appliedinthedirection paralleltothecentrelineofthehandle,foradurationofatleast5s. AnnexCdescribesasuitabletestprocedure. ENISO150871:2001 )E(9991:

39、178051OSI OSI 4 7.4.2 Testundertorque Subjecttheunionbetweentheworkingendandthehandletoatorqueof500N cmforadurationofatleast5s. AnnexDdescribesasuitabletestprocedure. 7.5 Hollowhandleleaktest 7.5.1 Heatedoiltest 7.5.1.1Apparatus 7.5.1.1.1 Heatresistantvessel. 7.5.1.1.2 Lightoil, ofminimumflashpoint2

40、20CinaccordancewithISO2592andnominalkinematicviscosityof 16,5mm 2 /sat100CinaccordancewithISO3104. 7.5.1.2Procedure Putthelightoilintotheheatresistantvessel. Heattheoilto(180 5)Candthencompletelyimmersetheelevatorhandleintheoilfor2min. Noairbubblesshallbeemittedduringthistest. 7.5.2Ultrasonic test 7

41、.5.2.1Apparatus 7.5.2.1.1 Ultrasoniccleaningapparatus. 7.5.2.1.2 Basketmadeofwirenet. 7.5.2.2Procedure Alignthedentalelevatorsinabasket(7.5.2.1.2).Putthebasketinanultrasoniccleaningapparatus(7.5.2.1.1)filled withwaterat(40 2)C.Shakethebasketcarefullybyhandandobservetheappearanceofthehandles.Ifair bu

42、bblesimmediatelyemergefromthehandlesurfaces,therearelargesizepinholesinthehandle. Sinkthebasketslowlytothebottom,leaveitfor3minandobserveagainwhetherairbubblesemergefromthe handlesurfaces. NOTE Afteralongtime,airbubblesformedfromairdissolvedinwatermayadheretothehandlesurfaces.Neglectthem. Subsequent

43、lyputthebasketinanultrasoniccleaningapparatusunderrunningwaterat(70 2)Cfor5min.The runningwaterwillremoveanyairbubblesadheringtothesurface.Iftheemergenceofsuchairbubblesis observed,thereareverysmallsizepinholesinthehandle. 8Marking Theinstrumentshallbeindeliblymarkedwiththefollowinginformation: a) manufacturersnameortradename; b) patternnumberorname; c)lot number. ENISO150871:2001 OSI )E(9991:178051OSI 5 AnnexA (informative) Measurementofdimensions A.1General Thismethodofmeasurementisapplicabletomosttypesofdentalhandinstrumentandisbasedontheuseofan opticalprojector.