BS EN ISO 9997-2000 Dental cartridge syringes《带麻醉剂管的牙科用注射器》.pdf

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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN ISO 9997:2000 The E

2、uropean Standard EN ISO 9997:1999 has the status of a British Standard ICS 11.060.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Dental cartridge syringesThis British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was pub

3、lished under the authority of the Standards Committee and comes into effect on 15 April 2000 BSI 04-2000 ISBN 0 580 34321 9 BS EN ISO 9997:2000 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the official English language version of EN ISO 9997:1

4、999. It is identical with ISO 9997:1999. It supersedes BS 7432:1991 which is withdrawn. The UK participation in its preparation was entrusted to Technical Committee CH/52, Dental instruments, which has the responsibility to: aid enquirers to understand the text; present to the responsible internatio

5、nal/European 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 secr

6、etary. Cross-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 these international or European publica

7、tions 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 contract. Users of

8、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, the ISO title

9、 page, pages ii to v, a blank page, pages 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.EUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM ENISO9997 December1999 ICS11.040.20;11.060.20 Sup

10、ersedesEN29997:1992 Englishversion Dentalcartridgesyringes(ISO9997:1999) Seringuesusagedentairepourcartouches(ISO 9997:1999) ZahnrztlicheAmpullenspritzen(ISO9997:1999) ThisEuropeanStandardwasapprovedbyCENon15December1999. CENmembersareboundtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatet

11、heconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheCentralSecretariatortoanyCENmember. ThisEuropeanStandardexistsinthreeofficialversions(English,French,Ge

12、rman).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheCentralSecretariathasthesamestatusast heofficial versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechRepublic,Denmark,Finland,France,Germany,Greece, Iceland,Irel

13、and,Italy,Luxembourg,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG CentralSecretariat:ruedeStassart,36B1050Brussels 1999CEN Allrightsofexploitationinanyformandbyanymeansreserved worldw

14、ideforCENnationalMembers. Ref.No.ENISO9997:1999EgaPe2 INESO99:799919 Corrected20000223 Foreword ThetextoftheInternationalStandardISO9997:1999hasbeenpreparedbyTechnicalCommitteeISO/TC 106“Dentistry“incollaborationwithTechnicalCommitteeCEN/TC55“Dentistry“,thesecretariatofwhichis heldbyDIN. ThisEuropea

15、nStandardsupersedesEN29997:1992. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidentical textorbyendorsement,atthelatestbyJune2000,andconflictingnationalstandardsshallbewithdrawnat thelatestbyJune2000. AccordingtotheCEN/CENELECInternalRegulations,thenationalstan

16、dardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark, Finland,France,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Netherlands,Norway,Portugal, Spain,Sweden,SwitzerlandandtheUnitedKingdom. Endorsementnotice ThetextoftheInternationa

17、lStandardISO9997:1999wasapprovedbyCENasaEuropeanStandard withoutanymodification. NOTE:NormativereferencestoInternationalStandardsarelistedinannexZA(normative). EN ISO 9997:1999Referencenumber ISO9997:1999(E) INTERNATIONAL STANDARD ISO 9997 Secondedition 1999-12-15 Dentalcartridgesyringes Seringues u

18、sage dentaire pour cartouches EN ISO 9997:1999ii EN ISO 9997:1999 iii Contents Page Foreword.iv Introduction.v 1 Scope1 2 Normativereferences1 3 Termsanddefinitions.1 4 Classification2 5 Requirements.2 5.1 General2 5.2 Materials.3 5.3 Dimensions.3 6 Testmethods3 6.1 Visualinspection.3 6.2 Aspirating

19、testforsyringesofType2a.3 6.3 AspiratingtestforsyringesofType2b.4 6.4 Plungerrodtests.4 6.5 Boilingwatertestforcorrosion.6 6.6 Autoclavetestforcorrosion.6 6.7 Thermaltest(metalsyringesonly).6 7 Informationsuppliedbythemanufacturer6 8 Marking.6 8.1 Markingofunitpack6 8.2 Markingofsyringe.6 AnnexA(inf

20、ormative)Imperialthreadsize.7 EN ISO 9997:1999iv Foreword ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISO memberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnical committees.Eachmemberbodyinterestedinasubject

21、forwhichatechnicalcommitteehasbeenestablishedhas therighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,in liaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnical Commission(IEC)onallmattersofelectrotechnicalstandardi

22、zation. InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3. DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting. PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote. Attenti

23、onisdrawntothepossibilitythatsomeoftheelementsofthisInternationalStandardmaybethesubjectof patentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights. InternationalStandardISO9997waspreparedbyTechnicalCommitteeISO/TC106, Dentistry, Subcommittee SC4, Dental instruments. Thissecon

24、deditioncancelsandreplacesthefirstedition(ISO9997:1990),whichhasbeentechnicallyrevisedas follows: thedentalcartridgesyringesarenowclassifiedintonon-aspiratingandaspiratingtypeswithasubclassification accordingtoaspirationofforceproducedbydrawingtheplungerorbythedeflectionofadiaphragm; improveddescrip

25、tionofplungerrodtest; corrosiontestinaccordancewithISO13402; markingnowrequireslotnumber. EN ISO 9997:1999 v Introduction ThisInternationalStandardspecifiesrequirementsfordentalcartridgesyringeswithISOmetricthreadsizesonly. However,attentionisdrawntotheexistenceofavarietyofsyringeswithImperialthread

26、sizes(seeannexA). EN ISO 9997:1999EN ISO 9997:1999INTENRATIONALTSADNADR ISO9:799(9991)E1 Dentalcartridgesyringes 1 Scope ThisInternationalStandardspecifiesrequirementsandtestmethodsfordentalcartridgesyringeswhichare reusabledentalsyringesoftheaspirating,non-aspiratingandself-aspiratingtypesusingcart

27、ridgeswithdentallocal anaesthetics. ThisInternationalStandardisnotapplicabletocartridgesyringeshavingamechanical-advantageactionfor creatinghighpressure. 2 Normativereferences Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext,constituteprovisionsof thisInternationalStan

28、dard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthese publicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedto investigatethepossibilityofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.For undatedreferences,thelatestediti

29、onofthenormativedocumentreferredtoapplies.MembersofIECandISO maintainregistersofcurrentlyvalidInternationalStandards. ISO261, ISO general purpose metric screw threads General plan. ISO965-1, ISO general purpose metric screw threads Tolerances Part 1: Principles and basic data. ISO1942-3, Dental voca

30、bulary Part 3: Dental instruments. ISO11499, Dental cartridges for local anaesthetics. ISO13402:1995, Surgical and dental hand instruments Determination of resistance against autoclaving, corrosion and thermal exposure. 3 Termsanddefinitions ForthepurposesofthisInternationalStandard,thetermsanddefin

31、itionsgiveninISO1942-3,ISO11499andthe followingapply. 3.1 aspiration processbywhichbloodorbodyfluidisdrawnintoananaestheticcartridge 3.2 unitpack packcontainingadentalcartridgesyringe 3.3 cartridge containerforlocalanaesthetics EN ISO 9997:19992 4 Classification ForthepurposesofthisInternationalStan

32、dard,dentalcartridgesyringesareclassifiedintothefollowingtypes: Type1:non-aspirating Type2:aspirating Type2a:aspirationbyforceproducedbydrawingtheplungerawayfromtheneedle Type2b:aspirationbyforceproducedbythedeflectionofadiaphragminthecartridge. 5 Requirements 5.1 General Generalrequirementsfordenta

33、lcartridgesforlocalanaestheticsasspecifiedinISO11499shallbemet. 5.1.1 Loadingandcartridgesize Thecartridgeshallbecapableofbeingloadedeitherfromthesideorfromtheback(breechtype).Thesyringeshall permittheappropriatesizeoflocalanaestheticcartridgetobesecurelyheldandincapableofbeingdislodged duringuse. T

34、estingshallbecarriedoutinaccordancewith6.1. 5.1.2 Viewingofcontents Thesyringeshallallowthesolutionforinjectiontobeobserved,includingtheresultofaspiration. Testingshallbecarriedoutinaccordancewith6.1,6.2and6.3. 5.1.3 Plungerrod Theplungerrodshallsatisfytest6.4beforeandafterthetestsin6.5,6.6and6.7. T

35、hecartridgeendoftheplungerrodshallcontaineitherapermanentlyattachedtiporameansofsecuringvarious plungertipssuppliedbythemanufacturerofthecartridgesyringe. Testingshallbecarriedoutinaccordancewith6.1. 5.1.4 Aspiratingsyringes 5.1.4.1 General Aspiratingsyringesshallpermitaspirationatanytimeduringuse.

36、NOTE Someaspiratingsyringesareintendedforuseonlywithcartridgesfittedwithspeciallydesignedrubberplungers. Thesesyringesmaynotaspiratewhenusedwithanyothercartridges. 5.1.4.2 Syringesinwhichaspirationisachievedbymovingthecartridgeplungerawayfromtheneedle (Type2a) Testingshallbecarriedoutusingacartridge

37、complyingwithISO11499.Aftertesting,thereagent(6.2.1)shallhave beenaspiratedintothecartridgeandtheharpoonorthreadedportionoftheplungerrodshallnothavedisengaged. Testingshallbecarriedoutinaccordancewith6.2.2. EN ISO 9997:1999 3 5.1.4.3 Syringesinwhichaspirationisachievedbydeflectionofadiaphragmwithint

38、hecartridge (Type2b) UsecartridgescomplyingwithISO11499.Aftertesting,thereagent(6.2.1)shallhavebeenaspiratedintothe cartridge. Testingshallbecarriedoutinaccordancewith6.3.2. 5.2 Materials 5.2.1 Metalsyringes Thepartsshallbecapableofwithstandingrepeatedsterilizationwithoutimpairingthefunctionofthesyr

39、ingeand withoutshowingsignsofcorrosionsuchasblemishes,pittingsordiscolouration. Testingshallbecarriedoutinaccordancewith6.1and6.5andsubsequently6.6and6.7. 5.2.2 Plasticssyringes,includingmetalsyringeswithplasticparts Thematerialshallbecapableofwithstandingrepeatedsterilizationwithoutimpairingthefunc

40、tionofthesyringeand withoutshowingdeteriorationofthematerialofconstruction. Testingshallbecarriedoutinaccordancewith6.1,6.5andsubsequently6.6. Anymetalpartshallcomplywiththerequirementsof5.2.1. 5.3 Dimensions ThedimensionsshallbeasspecifiedinFigure1andthemetric-threadedneedle-mountinghubshallmeetthe

41、 requirementsforscrewthreadsinaccordancewithISO261andISO965-1. 6 Testmethods 6.1 Visualinspection Visualinspectionshallbeconductedatnormalvisualacuitywithoutmagnification. 6.2 AspiratingtestforsyringesofType2a 6.2.1 Reagent Acolouredliquid,forexampleanaqueoussolutionofmethyleneblue,withaviscosityof4

42、mPas(0,04poise)at (23 2)C. 6.2.2 Procedure Assemblethesyringe,cartridgeandneedleofdimensions0,4mm 35mm.Fixtheharpoonorthreadedportionof theworkingendoftheplungerrodtotheplungerofthelocalanaestheticcartridgeinaccordancewiththe manufacturersinstructions.Immersetheneedleinthecolouredliquid(6.2.1)anddep

43、resstheplungerfor5mmat arateof5mm/sandthen,atthesamerate,withdrawtheplungeruntilthereagentappearsinthecartridgeorfora maximumdistanceof5mm.Repeatthetestthreetimeswiththesamelocalanaestheticcartridge. EN ISO 9997:19994 6.2.3 Observation Observewhethertherequirementof5.1.4.2isfulfilledaftereachwithdra

44、waloftheplunger. 6.3 AspiratingtestforsyringesofType2b 6.3.1 Reagent Acolouredliquid,forexamplesee6.2.1. 6.3.2 Procedure Assemblethesyringe,cartridgeandneedleofdimensions0,4mm 35mm.Depresstheplunger5mmduring1s. Releasethepressureandthenimmediatelyagaindepresstheplungerafurther5mmfor1s.Immediatelyaft

45、erthis seconddepression,immersetheneedleinthecolouredliquid(6.3.1)anddepresstheplungeratarateof5mm/s for5mmandreleasethepressure. 6.3.3 Observation Observewhethertherequirementof5.1.4.3isfulfilled. 6.4 Plungerrodtests 6.4.1 Plungerrodmovement Whentheplungerrodispulledfullyoutofanemptysyringeheldvert

46、ically,itshallbecapableoftravellingfreelyand smoothlythewholelengthundertheforceofgravityinbothverticaldirectionsbyinvertingthesyringe. 6.4.2 Plungerroddisplacement Withtheplungerinthefullyforwardpositioninthesyringe(withoutacartridge)themaximumsideways displacementmeasuredatthefrontendoftheplungerr

47、odtipshallnotexceed2mminanydirectionfromthe centralaxisofthesyringe. EN ISO 9997:1999 5 Dimensionsinmillimetres Key 1 Threadedneedlemountinghub 2 Viewingport 3 Workingendofplungerrod 4 Barrel 5 Fingergrip 6 Plungerrod 7 Handle a Whenafullcartridgeismounted. b Dimensionsincludesanyaspiratingdeviceinc

48、orporatedattheneedleendofthesyringebarrel.Ifnoaspiratingdeviceis incorporated,dimensionsshallbereducedto4 0 1 . NOTE Thedesignshownisnotnecessarilypreferabletoanyotherdesignthatmayexist. Figure1Dentalcartridgesyringe EN ISO 9997:19996 6.5 Boilingwatertestforcorrosion TestthedentalcartridgesyringeinaccordancewithISO13402:1995,clause4. Performthecyclefivetimes. Visuallyinspect(see6.1)forcompliancewiththerequirementsof5.2.1or5.2.2asappropriate. 6.6 Autoclavetest