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 It supersedes BS 7432:1991 which is withdrawn.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
