1、BRITISH STANDARD BS EN 13868:2002 Catheters Test methods for kinking of single lumen catheters and medical tubing The European Standard EN 13868:2002 has the status of a British Standard ICS 11.040.20 BS EN 13868:2002 This British Standard, having been prepared under the direction of the Health and
2、Environment Sector Policy and Strategy Committee, was published under the authority of the Standards Policy and Strategy Committee on 13 September 2002 BSI 13 September 2002 ISBN 0 580 40406 4 National foreword This British Standard is the official English language version of EN 13868:2002. The UK p
3、articipation in its preparation was entrusted to Technical Committee CH/84, Catheters and syringes, which has the responsibility to: A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international
4、 or European publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to i
5、nclude all the necessary provisions of a contract. Users are responsible for its 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 en
6、quiries 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. Summary of pages This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 14, an insid
7、e back cover and a back cover. The BSI copyright date displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. Date CommentsEUROPEANSTANDARD NORMEEUROPENNE EUROPISCHENORM EN13868 August2002 ICS11.040.20 Englishversion CathetersTestmethodsfo
8、rkinkingofsinglelumencatheters andmedicaltubing CathtersMthodesdessaidersistancelaplicature pourcathterssimplevoieettubesusagemdical KatheterPrfverfahrenfrdieKnickbildungvonKathetern mitEinzellumenundSchluchenzurmedizinischen Anwendung ThisEuropeanStandardwasapprovedbyCENon10May2002. CENmembersarebo
9、undtocomplywiththeCEN/CENELECInternalRegulationswhichstipulatetheconditionsforgivingthisEurope an Standardthestatusofanationalstandardwithoutanyalteration.Uptodatelistsandbibliographicalreferencesconcernings uchnational standardsmaybeobtainedonapplicationtotheManagementCentreortoanyCENmember. ThisEu
10、ropeanStandardexistsinthreeofficialversions(English,French,German).Aversioninanyotherlanguagemadebytra nslation undertheresponsibilityofaCENmemberintoitsownlanguageandnotifiedtotheManagementCentrehasthesamestatusasthe official versions. CENmembersarethenationalstandardsbodiesofAustria,Belgium,CzechR
11、epublic,Denmark,Finland,France,Germany,Greece, Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain,Sweden,SwitzerlandandUnitedKingdom. EUROPEANCOMMITTEEFORSTANDARDIZATION COMITEUROPENDENORMALISATION EUROPISCHESKOMITEEFRNORMUNG ManagementCentre:ruedeStassart,36B1050Brussels 2002C
12、EN Allrightsofexploitationinanyformandbyanymeansreserved worldwideforCENnationalMembers. Ref.No.EN13868:2002EEN13868:2002(E) 2 Contents page Foreword3 Introduction .4 1 Scope 4 2 Termsanddefinitions. .4 3 Testmethodsandresults .5 AnnexA (normative) KinkingShorttermtest .6 AnnexB (normative) KinkingL
13、ongtermtest. .11EN13868:2002(E) 3 Foreword ThisEuropeanStandardhasbeenpreparedbyTechnicalCommitteeCEN/TC205“Nonactivemedicaldevices“, thesecretariatofwhichisheldbyBSI. ThisEuropeanStandardshallbegiventhestatusofanationalstandard,eitherbypublicationofanidenticaltextor byendorsement,atthelatestbyFebru
14、ary2003,andconflictingnationalstandardsshallbewithdrawnatthelatest byFebruary2003. AnnexesAandBarenormative. AccordingtotheCEN/CENELECInternalRegulations,thenationalstandardsorganizationsofthefollowing countriesareboundtoimplementthisEuropeanStandard:Austria,Belgium,CzechRepublic,Denmark,Finland, Fr
15、ance,Germany,Greece,Iceland,Ireland,Italy,Luxembourg,Malta,Netherlands,Norway,Portugal,Spain, Sweden,SwitzerlandandtheUnitedKingdom.EN13868:2002(E) 4 Introduction Tubesforcathetersandforcertainothermedicaluseshavetobeflexible,butsimultaneouslytheyneedalsoto haveanappropriateminimumstrength.Thestreng
16、thandflexibilityallowthetubetobehandledeasily,soitcanbe bentaroundobstacles,forexamplewithinthehumananatomy.However,notallflexibletubesshowthesame behaviourduringbending.Sometubescanbendconsiderablywithoutkinkingi.ewithoutcollapsingandthereby drasticallyreducingthecrosssectionalarea,whileotherskinke
17、asily.Incatheterapplications,thisreductionofthe flowareacancauseseverereductionintheflowoffluids. 1Scope ThisEuropeanStandardspecifiestestmethodsforkinkingpropertiesforsinglelumencathetersandmedicaltubing, aspresentedforclinicaluse,whenbentinasingleplane.Itisrecognizedthatotherforcese.g.twistingwill
18、influence thebehaviouroftheproduct,butnostandardtestmethodsareyetavailable.Itisalsorecognizedthatsuchtubingcan beusedtotransportliquidsorgases.However,waterisusedasastandardtestmedium,asthepurposeofthis standardistoensureuniformityintheevaluationoftubingkinkproperties. NOTE Thismethodisdesignedforsi
19、nglelumentubingbutcanalsobeusedformultilumentubing.Itshouldbeensured thatthebendingisdoneintheworstcasedirection,unlessthiswouldnotpresentapossiblereallifesituation. 2 Termsanddefinitions ForthepurposesofthisEuropeanStandard,thefollowingtermsanddefinitionsapply. 2.1 kinkdistance platedistanceatkinki
20、ntheshorttermtestmethod 2.2 kinklength L lengthofthetubingloopatkinkinthekinktesttoolinthelongtermtestmethod 2.3 kinkpoint totalcollapseordistinct“knee”whenkinking(seeFigureA.4) 2.4 platedistance D distancebetweenthetwoplatesofthetensiletestingapparatusintheshorttermtestmethod(seeFigureA.3) 2.5 corr
21、ectedkinkdistance C platedistanceatkinkpluscorrectionforgrooves,resultoftheshorttermtestmethod(seeFigureA.3)EN13868:2002(E) 5 3 Testmethodsandresults Inordertoreflectthatplasticsmaterialsshowdifferentviscoelasticpropertiesandthattherearegreatvariationsin exposuretimefordifferentkindsofmedicaltubing,
22、itisnecessarytohaveatestmethodforrelativelyshorttermuse (1h),thelongtermtestmethod.The usershallchoosethetestmethodwhichbestreflectstheintendedproductfunction. ThetestmethodsarespecifiedinannexesAandB. Thetestsshallbeperformedontestsampleswhichareassimilaraspossibletothefinalproduct.Unlessotherwise
23、specifiedinaparticularproductstandard,thetestsshallbeperformedunderthesameconditionsofuseasthefinal producte.g.onsterilizedsamplesiftheendproductsaresterilizedandat37Cifthatisthecasefortheend productsinuse.EN13868:2002(E) 6 AnnexA (normative) KinkingShorttermtest A.1 Principle Thisisamethodfordeterm
24、iningthekinkresistanceofmedicaltubingforshorttermuse(1h).Thetubingis definedasbeingkinkedwhenthebendingcausesadecreaseinflowsuchthattheinitialflowthroughthestraight tubeisreducedbymorethan50%. NOTE Forcemeasurement.Asanalternativeprinciple,ithasbeenverifiedthatthekinkingbehaviouroftubingcanbe indica
25、tedbyforcemeasurement.ByfollowingtheprocedureinA.3,theplatedistanceatkinkisdefinedasthatdistancewhere thecorrespondingforcemeasurementstartsdecreasing(seeFigureA.4). A.2Apparatus A.2.1Kinktesttool ,forshorttermtest(seeFigureA.1)havinggroovesofdepthasgiveninTableA.1. A.2.2Tensiletestingapparatus ,oro
26、thermeansofapplyingpush/pullforces. A.2.3Flowmeter(s ),witharangeofatleast40%to100%offullflowthroughthestraighttubeandpreferablywith aquickresponsetime. A.2.4Plotter ,orothermeasurementrecordingdevice. A.2.5Asystemwithconstantpressureof(100050)mmhydrostatichead,constanttemperature(see clause3)within
27、2Candadequatewatersupply ,(seeFigureA.2)arrangedsothatthetesttubinghasthe smallestdiameterofthesystemtherebyprovidingthelargestresistancetotheflow.Iftheflowistoolow,ahigher constantpressurecanbeused,butitshallbeverifiedthatitwillnotaffecttheresults. A.2.6Caliper, tomeasuretheplatedistance. A.3Proced
28、ure A.3.1Beforestarting,ensurethatthewaterandsamplesareequilibratedtotherequiredtesttemperature,and recordthistemperature.Ifappropriate,bothsampleandenvironmentshouldbeofthetypicalusetemperatureof theproduct.Itisimportanttoavoidthepresenceofairbubblesinthetubingthroughoutthetest. A.3.2 Measuretheful
29、lflow(100%)inthestraighttube. A.3.3Selectakinktesttool(A.2.1,FigureA.1)withplateshavinggroovesofdepthappropriatetothesizeoftubing tobetested(seeTableA.1).Insertthetubecarefullyinthegroovessoitformsanarchbetweentwoparallelplates (seeFigureA.1),sothatthearchwillremainwithintheplatesduringtheentiretest
30、.Thetubeiskeptinplacebythe groovesintheplates.Connectthetubetothewatersystem(seeFigureA.2). Thestartdistanceshallbefixed,welldefined(e.g.50mm,100mmor200mm)andatleasttwicetheexpected kinkdistance(theparallelplatedistanceatthekinkpoint).Securethetubes(withtape,rubberbandsorsimilar) aroundtheplates,tom
31、akesurethatthetubewillremaininthegrooves(seeFigureA.1). A.3.4Useatensiletestingapparatustopushtheupperplatedownatafixedrateof40mm/min20mm/min. A.3.5Monitortheflowasafunctionoftheplatedistance.Thiscanbedoneby,forexample,useofaplotter, computerorvoltagemeter.Thetubeisdefinedaskinkedwhentheflowisreduce
32、dto50%oftheflowthroughthe straighttube.Recordthecorrespondingplatedistance( D).EN13868:2002(E) 7 A.3.6Repeattheprocedurewithatleastfournewtubes(allsamplesofequaldimensions),andrecordineach casetheplatedistance(i.e.atleast5determinations). A.3.7Calculatethemeanvalueofplatedistancewith50%offullflow.Co
33、rrectthisvalueaccordingtoFigureA.3. Thecorrectedvalueiscalled“thecorrectedkinkdistance“( C)andiscalculatedfromtheexpression: C= D+2 hd( 2 /) where Cisthecorrectedkinkdistanceinmillimetres; histhedepthofgrooveinmillimetres; distheoutsidediameterofthetubeinmillimetres. A.4 Expressionofresults Thecorre
34、ctedkinkdistanceisthekinkdistanceforthetubing. Recordthemeancorrectedkinkdistancetogetherwiththeoutsideandinsidediametersforthetubing. Theresultsshallbeexpressedase.g.: “KinkingtestaccordingtoEN13868,annexA(shortterm): Correctedkinkdistance:“. TableA.1Recommendeddepthofgrooveinkinktesttool Catheter
35、size (Charrire) Cathetersize (outsidediameter) mm Recommendedvalueof h(see FigureA.3) mm 62 1 , 4 12 4 2,8 18 6 4,2 24 8 5,7EN13868:2002(E) 8 FigureA.1ShorttermkinktesttoolassemblyEN13868:2002(E) 9 1 2 2 3 4 5 6 7 8 9 10 (100050)mm Key 1 Waterinlet 6 Clamps 2W a t e r 7K i n k t e s t t o o l 3 Wide
36、boretubing 8 Tensiletestmachine 4 Flowmeter 9 Sample 5 Overflow 10 Plotter FigureA.2KinktestsetupShorttermEN13868:2002(E) 10 h 1 2 45 90 Key 1 D(platedistance) 2 C (correctedkinkdistance) h isthedepthofthegroove FigureA.3Calculationofcorrectedkinkdistance 1 2 3 Key 1F o r c e 2 Platedisplacement 3 K
37、inkpoint FigureA.4ForceasfunctionofplatedisplacementformosttubingmaterialsEN13868:2002(E) 11 AnnexB (normative) KinkingLongtermtest B.1 Principle Thisisamethodfordeterminingthekinkresistanceofmedicaltubingforlongtermuse(1h).Thekinklengthis measuredasthecircumferenceoftheloopinwhichtheflowis50%orless
38、oftheflowthroughahorizontalstraight tubeofthesamelength.Forsomematerials,thekinkresistanceisdependantontemperatureandtimeand thereforeitisrecommendedthattheproductistestedinaccordancewithitsintendeduse(temperatureandtime). NOTE Observablekinking.Asanalternativeprinciple,ithasbeenverifiedthatthekinki
39、ngbehaviourofsometubingcanbe indicatedbyvisualobservation.ByfollowingtheprocedureinB.3,afterremovalfromtheoven/waterbath,thesamplesare visuallyexaminedforkinking. B.2 Apparatus B.2.1Kinktesttoolforlongtermtest ,(seeFigureB.1andFigureB.2),withholesofadiameter10%largerthan thetubebeingtested.Theleadin
40、holesshallbeatleast25mminlengthandthedistancebetweenthe correspondingholesshallbezero. B.2.2Oven/Waterbath, atthetemperaturechosenforthetest. B.2.3Ruler B.2.4Flowmeter(s), witharangeofatleast40%to100%offullflowthroughthestraighttube. B.2.5Asystemwithconstantpressureof(100050)mmhydrostaticheadandadeq
41、uatewatersupply, (seeFigureB.3)arrangedsothatthetesttubinghasthesmallestdiameterofthesystemtherebyprovidingthe largestresistancetotheflow. B.2.6Waterproofmarkerpen, withafinetip. B.3Procedure B.3.1 Anapproximatemeasureofthekinklengthisestimatedbycarryingoutashorttermtestinthekinktesttool (seeannexA)
42、.Fromthis,asuitablestartlengthcanbecalculatedbyadding5mmto15mm. B.3.2Cutthestraighttubinginsuitablepiecesandmarkthedesiredstartinglength0,5mmoneachone.The recommendednumbersofpiecesare10samplesformeasurementand2samplesofthesamelengthfor measurementofthefullflowinastraighttube. B.3.3Mountthesamples,s
43、othattheywillformacircleinthekinktesttool,bypullingtheminauniformmannerto themarkedlength(FigureB.1). B.3.4 Immediatelyplacethekinktesttoolwiththesamplesinanovenorwaterbathatthedesiredtemperatureand forthedesiredlengthoftime. B.3.5 Removethekinktesttoolfromtheoven/waterbath,andexaminethekinkedsamplesaccordingtoB.3.6. B.3.6Arrangethew
