1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 10637:2000 The
2、European Standard EN ISO 10637:2000 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Dental equipment High- and medium- volume suction systemsThis British Standard, having been prepared under the direction of the Health and Env
3、ironment Sector Committee, was published under the authority of the Standards Committee and comes into effect on 15 December 2000 BSI 12-2000 ISBN 0 580 36596 4 BS EN ISO 10637:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the official Eng
4、lish language version of EN ISO 10637:2000. It is identical with ISO 10637:1999. The UK participation in its preparation was entrusted to Technical Committee CH/60, Dental equipment, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/Europ
5、ean committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cr
6、oss-references 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 international or European publications referred
7、to in this document may be found in the 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 contr
8、act. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN ISO title page, the EN ISO foreword page,
9、 the ISO title page, pages ii to iv, pages 1 to 18, the annex ZA page and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued.EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO10637 October2000 ICS11.060.20 Englishversion DentalequipmentHig
10、handmediumvolumesuctionsystems (ISO10637:1999) MatrieldentaireSystmesdaspirationhautetmoyen volume(ISO10637:1999) ZahnrztlicheAusrstungenAbsaugsystememithoher undmittlererDurchflumenge(ISO10637:1999) ThisEuropeanStandardwasapprovedbyCENon9September2000. CENmembersareboundtocomplywiththeCEN/CENELECIn
11、ternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeof
12、ficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,Fra
13、nce,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG CentralSecretariat:ruedeStassart,36B1050Brussels 2000CEN Allrightsofexploitationinany
14、formandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.ENISO10637:2000E2egaP OSINE0002:73601 Foreword ThetextoftheInternationalStandardfromTechnicalCommitteeISO/TC106“Dentistry“ofthe InternationalOrganizationforStandardization(ISO)hasbeentakenoverasanEuropeanStandardby TechnicalCommitteeCE
15、N/TC55“Dentistry“,thesecretariatofwhichisheldbyDIN. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofan identicaltextorby endorsement,atthelatestbyApril2001,andconflictingnationalstandardsshallbe withdrawnatthelatestbyApril2001. AccordingtotheCEN/CENELECInternalRegul
16、ations,thenationalstandardsorganizationsofthe followingcountriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic, Denmark,Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxem bourg,Netherlands,Norway, Portugal,Spain,Sweden,SwitzerlandandtheUnitedKingdom. Endorsementnotice T
17、hetextoftheInternationalStandardISO10637:1999hasbeenapprovedbyCENasaEuropean Standardwithoutanymodification. NOTE:NormativereferencestoInternationalStandardsarelistedinannexZA(normative). EN ISO 10637:2000A Referencenumbe r ISO10637:1999 (E) INTERNATIONAL STANDARD ISO 10637 Firstedition 19990801 Den
18、talequipmentHighandmedium volumesuctionsystems MatrieldentaireSystmesdaspirationhautetmoyenvolume EN ISO 10637:2000)E(9991:73601OSI ii Contents Page 1Scop e1 2Normativereference s1 3Termsanddefinition s.2 4Classificatio n4 5Requirement s.5 6Samplin g.10 7Testprocedure s.10 8Informationtobesuppliedby
19、themanufacture r14 9Markin g.15 10Packagin g.16 AnnexA (normative) Sequenceoftestin g17 EN ISO 10637:2000OSI )E(9991:73601OSI iii Foreword ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISO memberbodies).TheworkofpreparingInternationalStandardsisno
20、rmallycarriedoutthroughISOtechnical committees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhas therighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnongovernmental,in liaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInte
21、rnationalElectrotechnical Commission(IEC)onallmattersofelectrotechnicalstandardization. InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3. DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting. PublicationasanInterna
22、tionalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote. InternationalStandardISO10637waspreparedbyTechnicalCommitteeISO/TC106, Dentistry,Subcommittee SC6, Dentalequipment . AnnexAformsanormativepartofthisInternationalStandard. EN ISO 10637:2000)E(9991:73601OSI OSI iv Introduction Th
23、isInternationalStandardcontainsspecificationsforhighandmediumvolumesuctionsystemswhichareusedin thedentalsurgeryaspartofthedentalequipment. TheaimofthisInternationalStandardistoensurethereliablefunctionofsuctionsystemsandthenecessarysafety incommonusageandwithinnormalambientconditions. Anyitemofdent
24、alequipmentrecommendedbythemanufacturerforuseinconnectionwithsuctionsystemsshould notrendertheequipmentunsafe. EN ISO 10637:2000LANOITANRETNIDRADNATS OSI )E(9991:73601OSI 1 Dentalequipment Highandmediumvolumesuctionsystems 1Scope ThisInternationalStandardappliestohighandmediumvolumesuctionsystemswhi
25、chareitemsofdental equipment.Theyareusuallyanintegralpartofadentalunit. ThisInternationalStandardspecifiesperformanceandsafetyrequirementsaswellastestproceduresforhighand mediumvolumesuctionsystems.Italsocontainsspecificationsonmanufacturersinstructions,markingand packaging. ThisInternationalStandar
26、dtakespriority,whereapplicable,overIEC606011,asspecifiedintheindividualclauses ofthisInternationalStandard. ThisInternationalStandardisnotapplicabletolowvolumesuctionsystems. 2Normative references Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsof
27、thisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthese publicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedto investigatethepossibilityofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.For undatedrefe
28、rences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIEC maintainregistersofcurrentlyvalidInternationalStandards. ISO19424, DentalvocabularyPart4:Dentalequipment. ISO7494, Dentalunits. lSO9687, DentalequipmentGraphicalsymbols. IEC603351, Safetyofhouseholdandsimilarelectrical
29、appliancesPart1:Generalrequirements. IEC606011:1988, MedicalelectricalequipmentPart1:Generalrequirementsforsafety. IEC60651, Soundlevelmetres. EN ISO 10637:2000)E(9991:73601OSI OSI 2 3 Termsanddefinitions ForthepurposesofthislnternationalStandard,thetermsanddefinitionsgiveninlEC606011:1988,clause2,a
30、nd thefollowingapply. 3.1 suctionsystem activeentityofdentalequipment,includingasuctionmachine,whichenablesanairflowtobeinducedwhichis designedtoremovespray,liquidsandsolidsfromthemouthofthedentalpatientduringdentaltreatment SeeFigure1. NOTE Itisacombinationofapparatusandaccessories.Somecomponentsar
31、edescribedin3.2to3.7. 3.2 suctiondevice passiveentitywhichcanonlyinduceanairflowwhenconnectedtoasuctionmachine 3.3 airseparator apparatuswhichseparatesliquidsandsolidsfromthesuctionair 3.4 filter apparatuswhichretainssolidsfromtheairandliquidspassingthroughit 3.5 centralsystem vacuumsystemhavingatle
32、astonesuctionmachinewhichservesmorethanonedevice 3.6 accessories cannula,manifold,filterand/ormobilesupport 3.7 cannulaconnector cartridge,attheendofthehosepartofthesuctionsystem,intendedforfittingofcannulaeandforplacementinthe mobilesupport NOTE Alsocalledasuctionhandpiece. 3.8 lowvolumesuctionsyst
33、em suctionsystemwithanairintakeoflessthan90l/min EN ISO 10637:2000OSI )E(9991:73601OSI 3 Figure1Suctionsystems EN ISO 10637:2000)E(9991:73601OSI OSI 4 4Classification 4.1 Accordingtotheairvolumeflowrateprovided SuctionsystemstowhichthisInternationalStandardisapplicableareclassifiedaccordingtotheairv
34、olumeflowrate providedasfollows: a) Highvolumesuctionsystem Suctionsystemwithanairintakeofmorethan250litresperminute(l/min)ineachsuctiondevice. b) Mediumvolumesuctionsystem Suctionsystemwithanairintakebetween90l/minand250l/minineachsuctiondevice. 4.2 Accordingtothetypeofsuction Suctionsystemsareclas
35、sifiedaccordingtothetypeofsuctionasfollows: a)Dry system Suctionsysteminwhich,withanairseparator,liquidsandsolidshavebeenremovedfromtheairflowbefore theairentersthesuctionmachineandinwhichtheseparatorandthesuctionmachinearetwodifferent devices.SeeFigure1. b)Semidry system Suctionsysteminwhich,withan
36、airseparator,liquidsandsolidshavebeenremovedfromtheairflowbefore theairentersthesuctionmachineandinwhichtheseparatorandthesuctionmachinearecombinedintoone device.SeeFigure1. c)Wet system Suctionsysteminwhichsolidshavebeenremovedfromtheairflowbyafilterbeforeairandliquidenterthe suctionmachine,whereth
37、eyinturnareseparated.SeeFigure1. 4.3 Accordingtothetypeofprotectionagainstelectricshock (seeIEC606011) Suctionsystemsareclassifiedaccordingtothetypeofprotectionagainstelectricshockbyclassesasfollows: a) ClassIequipment Equipmentinwhichprotectionagainstelectricshockdoesnotrelyonbasicinsulationonly,bu
38、tincludesan additionalsafetyprecautionwhichprovidesmeansfortheconnectionofaccessibleconductivepartstothe protective(earth)conductorinthefixedwiringoftheinstallationsuchthataccessibleconductivepartscannot becomeliveintheeventofafailureofthebasicinsulation. b) ClassIIequipment Equipmentinwhichprotecti
39、onagainstelectricshockdoesnotrelyonbasicinsulationonly,butinwhich additionalsafetyprecautionssuchasdoubleinsulationorreinforcedinsulationareprovided,therebeingno provisionforprotectiveearthingorrelianceuponinstallationconditions. EN ISO 10637:2000OSI )E(9991:73601OSI 5 4.4 Accordingtothedegreeofprot
40、ectionagainstelectricshock (seeIEC606011) Suctionsystemsareclassifiedaccordingtothedegreeofprotectionagainstelectricshockbytypeasfollows: a) TypeBequipment(seeIEC606011:1988,2.2.24) ClassIorIIequipmentorequipmentwithaninternalelectricalpowersourceprovidinganadequatedegreeof protectionagainstelectric
41、shock,particularlyregarding: allowableleakagecurrent; reliabilityoftheprotectiveearthconnection,ifpresent. NOTE TypeBequipmentis,forexample,suitableforintentionalexternalandinternalapplicationtothepatient, excludingdirectcardiacapplication. b) TypeBFequipment(seeIEC606011:1988,2.2.25) TypeBequipment
42、withanFtypeisolated(floated)appliedpart. 4.5 Accordingtothemodeofoperation (seeIEC606011:1988,2.10) Suctionsystemsareclassifiedasapplicableforeitherintermittentorcontinuousoperation. 5Requirements 5.1General Thisclausecontainsrequirementsrelevanttohighandmediumvolumesuctionsystems.Manyofthese requir
43、ementsarequantitativelyverifiableasdetailedinclause7. Somerequirementsareobjectivelyverifiablebyvisualinspection. Compliancewithsomerequirements,however,involvesasubjectivedecisionofqualifiedtestingpersonnel.Itis envisagedtoincludeinthesecasesquantitativetestsassoonasresultsofrelevantresearchworkare
44、available. Electricalrequirementsareonlyapplicabletoelectricallypoweredhighandmediumvolumesuctionsystemsand highandmediumvolumesuctiondevicesintendedforuseinpoweredsuctionsystems.However,thegeneral requirementsinIEC606011whicharereferredtoareapplicabletononelectricalsuctionsystemsanddevicesas well. 5.2General requirements 5.2.1Design 5.2.1.1 Highandmediumvolumesuctionsystemsshallbedesigned,const
