ISO TS 6417 2025.docx

1、ISOTechnicalSpecificationISO/TS6417Firstedition2025-06MicrofluidicpumpsSymbolsandperformancecommunicationReferencenumberISO/TS6417:2025(en)COPYRIGHTPROTECTEDDOCUMENTISO2025Allrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedoruti

2、lizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocopying,orpostingontheinternetoranintranet,withoutpriorwrittenpermission.PermissioncanberequestedfromeitherISOattheaddressbeloworISO,smemberbodyinthecountryoftherequester.ISOcopyrightofficeCP401Ch.deBlandonnet8CH-1214Vernier,Ge

3、nevaPhone:+41227490111Email:copyrightiso.orgWebsite:www.iso.orgPublishedinSwitzerlandContentsPageForewordivIntroductionv1 Scope12 Normativereferences13 Termsanddefinitions14 Symbols25 StandardDatasheets25.1 Naming25.2 Schematic/symbol25.3 Technologycharacteristics35.3.1 General35.3.2 ActuationType35

4、3.3 Requirementofadditionalconsumables35.3.4 Wettedmaterial35.3.5 Reversibleflow35.3.6 Closedlooppossibility35.3.7 Operationallifetime35.3.8 Reusable35.4 Generalworkingconditions45.4.1 Maximumpressuredelivered45.4.2 Abilitytoworkinanincubator45.4.3 Self-priming45.4.4 Lifetimeuntiloutofaccuracy45.4.

5、5 Self-heating45.4.6 Soundlevel45.4.7 Certifications45.4.8 Backpressure45.5 Electricalcharacteristics45.5.1 Powersupply45.5.2 Electromagneticcompatibility45.6 Mechanicalcharacteristics55.6.1 Internalvolume55.6.2 Dimension-Size55.6.3 Weight55.6.4 Workingpressure55.6.5 Integrationlevel55.6.6 Outlet/In

6、letconnectorandaccessories55.7 Flowcharacteristics55.7.1 General55.7.2 Standarddeviation(stability)55.7.3 Responsetime55.7.4 Openstatefluidicresistance65.7.5 Flowraterange6AnnexA(informative)Datasheetandsymbolsforpumps7Bibliography14ForewordISO(theInternationalOrganizationforStandardization)isaworld

7、widefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,gover

8、nmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.TheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthermaintenancearedescribedintheISO/IECDirectives,Pa

9、rt1.Inparticular,thedifferentapprovalcriterianeededforthedifferenttypesofISOdocumentshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(seeWWW.iso.org/directives).ISOdrawsattentiontothepossibilitythattheimplementationofthisdocumentmayinvolvetheuseof（八）pa

10、tent(三).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimedpatentrightsinrespectthereof.Asofthedateofpublicationofthisdocument,ISOhadnotreceivednoticeof（八）patent(三)whichmayberequiredtoimplementthisdocument.HoweverlImplementersarecautionedthatthismaynotrepresentthelatestinform

11、ation,whichmaybeobtainedfromthepatentdatabaseavailableatWWW.iso.org/patents.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.Anytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddoesnotconstituteanendorsement.Foranexplanationofthevoluntarynatureofstandards,the

12、meaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationaboutISOsadherencetotheWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoTrade(TBT),seeWWW.iso.org/iso/foreword.htmLThisdocumentwaspreparedbyTechnicalCommitteeISO/TC48,Laboratoryequipment.Anyfeedbackor

13、questionsonthisdocumentshouldbedirectedtotheusersnationalstandardsbody.AcompletelistingofthesebodiescanbefoundatWWW.iso.org/membnrs.htmLIntroductionSeveralmicrofluidicpumpsareavailableonthemarket.Therelevanttechnicalinformationfromthedatasheetwillenableend-userstocomparetheperformanceofthemicrofluid

14、icpumpsandtochoosethebest-fittedpumpfortheirapplication.Withoutastandardizeddatasheet,thecomparisonoftheperformanceofdifferentmicrofluidicpumpsisoftennotpossibleduetothelackofsimilarinformationordivergentdefinitionsofsimilarperformancecharacteristics.Thefollowinggroupsofcharacteristicsaredefined,des

15、cribedandexplainedwithexampleswhereitisappropriate: naming; schematic/symbol; technologycharacteristics; generalworkingconditions; electronicalcharacteristics; mechanicalcharacteristics; flowcharacteristics.MicrofluidicpumpsSymbolsandperformancecommunication1ScopeThisdocumentprovidessymbolsanddefine

16、sstandarddatasheetsforsomeofthemostoftenusedmicrofluidicPUmPs,suchastheperistalticpump,pressurepump,syringepumpanddiaphragm/membranepump.2 NormativereferencesThefollowingdocumentsarereferredtointhetextinsuchawaythatsomeoralloftheircontentconstitutesrequirementsofthisdocument.Fordatedreferences,onlyt

17、heeditioncitedapplies.Forundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)applies.ISO10991,MicrofluidicsVocabulary3 TermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO10991andthefollowingapply.ISOandIECmaintainterminologydatabasesforuseins

18、tandardizationatthefollowingaddresses: ISOOnlinebrowsingplatform:availableathttps:WWW.iso.org/obp IECElectropedia:availableathttps:WWW.electropedia.org/3.1peristalticpumpvolumetricpumpinwhichtheflowoftheliquidisachievedbythecyclicdeformation(expansionandcontraction)ofaflexiblebodySOURCE:ISO5681:2020

19、3.2.5.5modified“thecontinuousprogressionofadeformationinaflexibletube”replacedby,thecyclicdeformation(expansionandcontraction)ofaflexiblebody”.3.2pressurepumpvolumetricpumpinwhichtheflowisachievedbythepressurizationofagastodrivealiquidintoasystemSOURCE:ISO5681:2020,3.2.5.1modified“meansofthepositiv

20、edisplacementoftheliquidreplacedbynpressurizationofagastodrivealiquidintoasystem”.3.3syringepumpvolumetricpumpinwhichtheflowoftheliquidisachievedbymeansofoneormoresingleactionsyringe(三)orsimilarcontainer(三)SOURCE:IEC60601-2-24:2012,201.3.220,modified“infusionreplacedbyvolumetric;intendedforcontrolle

21、dinfusionofliquidsintothepatient“replacedby“inwhichtheflowoftheliquidisachieved;(egwherethecartridge/bagisemptiedbypositivepressureappliedtothecartridge/bag)inwhichdeliveryrateisindicatedinvolumeperunitoftimeorunitsrelatedtodrugdosage“wasdeleted.3.4diaphragmpumpmembranepumpvolumetricpumpinwhichthefl

22、owoftheliquidisachievedbythedeformationofadiaphragmSOURCE:ISO5681:2020,325.3,modifiedmembranepumphasbeenaddedasapreferredterm.4 SymbolsThesymbolspresentedinTabIe1usebasicelementsongraphicalsymbolsaccordingtoISO7000,IEC80416-ISO80416-2andIEC80416-31)Table1Graphicsymbolsfordifferenttypesofmicrofluidic

23、pumpsPERISTALTICPUMP(ISO14617-2-X440110PRESSUREPUMP(ISO14617-2-X2426)SYRINGEPUMP(ISO14617-2-X4402)ODIAPHRAGM/MEMBRANEPUMP(ISO14617-2-X4403)5 StandardDatasheets5.1 NamingAlongwiththededicatedmodelreference,whichismanufacturer-specific,anexplicittermcanbeinthedevicesnamebasedonthemainworkingprincipleo

24、fthepump.EXAMPLEBrandA,ModelB,Peristalticpump.5.2 Schematic/symbolAsymbolforthepumpshouldbeprovidedinthedatasheetinaccordancewithTable1.Whenneeded,additionalsymbolsofassociatedcomponentsandtheirrespectivewiring/pipingshouldbeprovidedaccordingtotherelevantstandard(e.g.ISO7000lIEC80416-1,ISO80416-2,IE

25、C80416-3).1)ThegraphicalsymbolcollectionofISO7000,IEC80416-1,ISO80416-2,IEC80416-3,andISO14617-2canbepreviewedandpurchasedontheOnlineBrowsingPlatform(OBP),WWW.iso.org/obp.5.3 Technologycharacteristics5.3.1 GeneralThetechnologycharacteristicsaccordingto5.3.2to5.3.8canbeincludedinthepumpsdatasheet.NOT

26、EThelistofcharacteristicsisnon-exhaustiveanditispossiblethatsomecharacteristicsarenotappropriateforaspecificpumpgivenitsworkingprincipleandspecificdesign.AnneXApresentsexamplesofdatasheetsfordifferentworkingprinciplesandtheirrespectivecharacteristicsandspecifications.5.3.2 ActuationTypeTheactuationt

27、ypeofagivenpumpcorrespondstothemainenergysourcewhichisusedtostartand/orputthepumpintooperation.Examplesforactuationtypesareelectrical,pneumatic,ormechanical(hand-drivenorrequestinganexternalmechanicalactuator).Inanycase,theminimumandmaximumintensitylevelsofthecharacteristicsoftherequiredenergyshould

28、beprovidedinthedatasheet(examplesare4VDCto10VDC,or0,2barto2bar1bar=0,1MPa=IO5Pa;1MPa=1Nmm2.),alongwiththerequiredstabilityand/orperiodicity.5.3.3 RequirementofadditionalconsumablesAnyrequirementforadditionalconsumables,necessaryforthecorrectoperationofthepump,shouldbespecified,alongwiththeirexpected

29、lifetime,dimensions,materials,etc.Examplesareremovablesyringesforsyringepumps,maintubing,fittingsandconnectors,gaskets,membranes,etc.forperistalticpumps.5.3.4 WettedmaterialInformationaboutallmaterialsincontactwiththefluidshouldbegiveninthedatasheet.Whenappropriate,biocompatibility,compatibilitywith

30、organicsolvents,pH-resistancerange,temperatureandpressureoperationalrangesofallwettedmaterialsshouldbeprovidedinthedatasheet.5.3.5 ReversibleflowInformationaboutthepossibilityofgeneratingand/orhandlingofflowinalternativedirectionsshouldbegiveninthedatasheet.Ifappropriate,aspecificdurationtolerancefo

31、rtheflowinalternativedirectionsshouldbegiven.5.3.6 ClosedlooppossibilityThepossibilitytoactuateand/orcontroltheflowbyintegratingthepumpinaclosedloopsystemcanbegiveninthedatasheet.Informationabouttherequiredcontrolsignal(三)(electrical,pneumatic)andtheiroperatingrangescanbegiven.Additionalinformationa

32、boutthesensor(三)usedforfeedbackcontrolcanbeincludedinthedatasheetaswell.5.3.7 OperationallifetimeExpecteddurationforwhichthepumpisoperatingunderthenominalspecificationscanbeincludedinthedatasheet.5.3.8 ReusableUseofapumpforthesamepurposeforwhichitwasconceived,withorwithoutthesupportofauxiliaryconsum

33、ablescanbeincludedinthedatasheet.Indicationofthereusabilityofthepumpshouldbegiven,alongwiththeexpectedlifespan.5.4 Generalworkingconditions5.4.1 MaximumpressuredeliveredThemaximumworkingpressureofthepumpshouldbegiveninthedatasheet.Ifappropriate,amaximumpressureperoperationaland/orconsumable-specific

34、conditionofuseshouldbespecifiedinthedatasheet.EXAMPLE4barmaximumfora1mlplasticsyringe.1.1.2 AbilitytoworkinanincubatorTheabilitytoworkinanincubatorcanbespecifiedinthedatasheet.Whenneeded,restrictionstotheoperationalperformances(flowraterange,etc.)canbedescribed.1.1.3 Self-primingIfthepumphastheabili

35、tytoself-primeitsinternalvolume,theself-primingprocedureshouldbegiveninthedatasheet.1.1.4 LifetimeuntiloutofaccuracyThelifetimeuntiloutofaccuracyshouldbegiveninthedatasheet,inunitoftime,ornumberofoperatingcycles.Example:forperistalticpumps,lifetimecanbeexpressedinnumberofrotations.1.1.5 Self-heating

36、Thelevelofself-heatingshouldbegivenintermsofunitoftemperatureperoperationallevel(flowrate,outletpressure)andforagivenfluid(examples:purewater,air,etc.).1.1.6 SoundlevelThesoundlevel,indB,shouldbegiveninthedatasheet.Thesoundlevelshouldbegivenforthenominaloperatingconditionand/orforthemaximumoperating

37、condition.Alternatively,thesoundlevelrange(e.g.35dBto40dB)canbegivenforaspecifiedoperatingrange.1.1.7 CertificationsDescriptionofthereferencedocumentorlegislationappliedtothecertificationoftheproductshouldbeincludedinthedatasheet.1.1.8 BackpressureThemaximumlevelofback-pressureforwhichthepumpremains

38、withinitsoperationalconditions(flowraterange,accuracy)shouldbespecifiedinthedatasheet.5.5 Electricalcharacteristics5.5.1 PowersupplyTherequiredcharacteristicsforthepowersupplyshouldbeprovidedinthedatasheetalongwiththerequiredstabilityand/orperiodicity,suchas4Vto10VDC.5.5.2 Electromagneticcompatibili

39、tyTheabilityofanequipmentorasystemtofunctionsatisfactorilyinitselectromagneticenvironmentwithoutintroducingintolerableelectromagneticdisturbancestoanythinginthatenvironment.Electromagneticcompatibility(compliance)levelshouldbequantifiedinthedatasheet.Ifappropriate,agreementtoaspecificelectromagnetic

40、compliancestandardordirectiveshouldbedescribedinthedatasheet.5.6 Mechanicalcharacteristics5.6.1 InternalvolumeMaximumtotalavailablevolumecomprisedwithinafluidiccomponent,deviceorsystemundernormalatmosphericpressure;thisisthetotalofdeadvolumeandsweptvolume.Expressedinvolumequantitiessuchasmm3ormicrol

41、iter.5.6.2 Dimension-SizeTheexternaldimensionsofthepumpshouldbeprovidedinthedatasheet,eitherwiththeadequatevaluesindimensionalunit,orillustratedinatechnicaldrawing.Foreachcomponentsdimension,tolerancescanbeprovided.5.6.3 WeightTheunloadedtotalweightofthepumpshouldbeprovidedinthedatasheet.Whenusedwit

42、hnecessaryaccessoriesorconsumables(syringes,tubing,etc)themanufacturershoulddescribeinthedatasheetiftheindicatedweightisgivenforapumpwithorwithoutitsconsumables/accessories.5.6.4 WorkingpressureTheoperatingworkingpressureofthepumpshallbegiveninpressureunit,forspecifiedoperatingconditionsandaspecifie

43、dfluid.5.6.5 IntegrationlevelTheintegrationpossibilities/levelcanbedescribedinthedatasheet,forexamplebylistingcompatiblecomponentsand/ordevices,orexamplesofintegrationinothersystems.5.6.6 Outlet/InletconnectorandaccessoriesThetypesofrequiredcompatibleinputand/oroutputconnectorsandaccessoriesshouldbe

44、specifiedinthedatasheet.EXEMPLESLuer,Luer-Iock,clamps,hose,etc.5.7 Flowcharacteristics5.7.1 GeneralThecircumstancesunderwhichtheflowcharacteristicsarestatedshouldbedescribed.5.7.2 Standarddeviation(stability)Thestabilityoftheflowrategeneratedbythepumpshouldbeexpressedinthedatasheetbyaquantifiedvalue

45、ofitsstandarddeviation.Thestandarddeviationcaneitherbeexpressedinflowunits,byasinglevalueorarangeofvalues,orbyapercentageofthemaximumornominalflow.5.7.3 ResponsetimeIntervaloftimebetweenthesetpointstepchangethemomenttheflow(orgeneratedpressure)hasincreasedx%ofisintendedriseorx%ofitsintendedfall.Typi

46、cally,x=90.Expressedintimeunits.Forapump,theflowaccuracyshouldbegivenforspecifiedoperatingconditionsandforaspecifiedfluid.5.7.4 OpenstatefluidicresistanceForrecirculatingpumps,theopenstate(i.e.ofthepumpitselffluidicresistanceshouldbegiveninpressureoverflowrateunits.5.7.5 FlowraterangeTheflowraterang

47、eshouldbegivenforspecifiedoperatingconditionsandforaspecifiedfluid.AnnexA(informative)DatasheetandsymbolsforpumpsA.lGeneralTablesA.ltoA.4presentexamplesforthestructureofdatasheetsandsymbolsforthefourmostimportantpumpsusedinmicrofluidics:syringe-,peristaltic-,diaphragm/membrane-andpressurepump.A.2Exa

48、mpleforthestructureofadatasheetforperistalticpumpTableA.lDatasheetforperistalticpumpsPERISTALTICPUMPGraphicalsymbol(ISO14617-2-X4401)SP&IDsymbol3DescriptionTechnologycharacteristicsActuationtypeDeadvolumeRequirementofadditionalconsumableTubingsize(IDODLength)TubingadaptorReusableWettedmaterialReversi