IEC 61847-1998 Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics《超声学 外科装置 基本输出特性的测量和标示》.pdf

1、INTERNATIONAL STANDARD IEC 61847 Firstedition 199801 UltrasonicsSurgicalsystems Measurementanddeclarationofthebasic outputcharacteristics UltrasonsSystmesdechirurgie Mesureetdclarationdescaractristiques desortie Referencenumber CEI/IEC61847:1998(E)Numbering Asfrom1January1997allIECpublicationsareiss

2、uedwithadesignationinthe60000series. Consolidatedpublications ConsolidatedversionsofsomeIECpublicationsincludingamendmentsareavailable.Forexample,editionnumbers 1.0,1.1and1.2refer,respectively,tothebasepublication,thebasepublicationincorporatingamendment1and thebasepublicationincorporatingamendments

3、1and2. Validityofthispublication ThetechnicalcontentofIECpublicationsiskeptunderconstantreviewbytheIEC,thusensuringthatthecontent reflectscurrenttechnology. InformationrelatingtothedateofthereconfirmationofthepublicationisavailableintheIECcatalogue. Informationontherevisionwork,theissueofrevisededit

4、ionsandamendmentsmaybeobtainedfromIECNational CommitteesandfromthefollowingIECsources: IECBulletin IECYearbook Onlineaccess* CatalogueofIECpublications Publishedyearlywithregularupdates (Onlineaccess)* Terminology,graphicalandletter symbols Forgeneralterminology,readersarereferredtoIEC60050: Interna

5、tionalElectrotechnicalVocabulary (IEV). Forgraphicalsymbols,andlettersymbolsandsignsapprovedbytheIECforgeneraluse,readersarereferredto publicationsIEC60027: Lettersymbolstobeusedinelectricaltechnology ,IEC60417: Graphicalsymbolsforuseon equipment.Index,surveyandcompilationofthesinglesheets and IEC60

6、617: Graphicalsymbolsfordiagrams. IECpublicationspreparedbythesame technicalcommittee TheattentionofreadersisdrawntotheendpagesofthispublicationwhichlisttheIECpublicationsissuedbythe technicalcommitteewhichhaspreparedthepresentpublication. * Seewebsiteaddressontitlepage.INTERNATIONAL STANDARD IEC 61

7、847 Firstedition 199801 UltrasonicsSurgicalsystems Measurementanddeclarationofthebasic outputcharacteristics UltrasonsSystmesdechirurgie Mesureetdclarationdescaractristiques desortie CommissionElectrotechniqueInternationale InternationalElectrotechnicalCommission Pourprix,voircatalogueenvigueur Forp

8、rice,seecurrentcatalogue IEC1998Droitsdereproductionrservs Copyrightallrightsreserved Aucunepartiedecettepublicationnepeuttrereproduiteni utilisesous quelqueformequecesoitetparaucun procd,lectroniqueoumcanique,ycomprislaphoto copieetlesmicrofilms,sanslaccordcritdelditeur. Nopartofthispublicationmayb

9、ereproducedorut ilizedin anyformorbyanymeans,electronicormechanical, includingphotocopyingandmicrofilm,withoutpermissionin writingfromthepublisher. InternationalElectrotechnicalCommission 3,ruedeVarembGeneva,Switzerland Telefax:+41229190300 email:inmailiec.ch IECwebsitehttp:/www.iec.ch CODEPRIX PRIC

10、ECODE P2 61847IEC:1998(E) CONTENTS Page FOREWORD . 3 INTRODUCTION . 4 Clause 1 Scope . 5 2 Normativereferences 5 3 Definitions. 6 4 Listofsymbols 9 5 Generalmeasurementrequirements 9 5.1 Operatingconditions 9 5.2 Loadconditions 9 5.3 Preparationformeasurements . 10 6 Measurementprocedures 10 6.1 Pri

11、marytipvibrationexcursion . 10 6.2 Secondarytipvibrationexcursion. 11 6.3 Drivefrequency 11 6.4 Tipvibrationfrequency. 11 6.5 Derivedoutputacousticpowerandoutputacousticpower 12 6.6 Directivitypattern. 13 6.7 Primarytipvibrationexcursionmodulation 13 6.8 Dutycycle 14 6.9 Quiescentelectricalpower . 1

12、4 6.10 Maximumelectricalpower 14 6.11 Primaryacousticoutputarea 15 6.12 Secondaryacousticoutputarea . 15 6.13 Powerreserveindex 15 7 Declarationofoutputcharacteristics 15 Figures 16 Annexes A Measurementmethodsandconditions. 21 B Theoryofoperationofultrasonicsurgicaldevices 26 C Bibliography 2961847

13、IEC:1998(E) 3 INTERNATIONALELECTROTECHNICALCOMMISSION _ ULTRASONICSSURGICALSYSTEMS Measurementanddeclarationofthebasicoutputcharacteristics FOREWORD 1) TheIEC(InternationalElectrotechnicalCommission)isaworldwideorganizationforstandardizationcomprising allnationalelectrotechnicalcommittees(IECNationa

14、lCommittees).TheobjectoftheIECistopromote internationalcooperationonallquestionsconcerningstandardizationintheelectricalandelectronicfields.To thisendandinadditiontootheractivities,theIECpublishesInternationalStandards.Theirpreparationis entrustedtotechnicalcommittees;anyIECNationalCommitteeinterest

15、edinthesubjectdealtwithmay participateinthispreparatorywork.International,governmentalandnongovernmentalorganizationsliaising withtheIECalsoparticipateinthispreparation.TheIECcollaboratescloselywiththeInternationalOrganization forStandardization(ISO)inaccordancewithconditionsdeterminedbyagreementbet

16、weenthetwo organizations. 2) TheformaldecisionsoragreementsoftheIEContechnicalmattersexpress,asnearlyaspossible,an internationalconsensusofopinionontherelevantsubjectssinceeachtechnicalcommitteehasrepresentation fromallinterestedNationalCommittees. 3) Thedocumentsproducedhavetheformofrecommendations

17、forinternationaluseandarepublishedintheform ofstandards,technicalreportsorguidesandtheyareacceptedbytheNationalCommitteesinthatsense. 4) Inordertopromoteinternationalunification,IECNationalCommitteesundertaketoapplyIECInternational Standardstransparentlytothemaximumextentpossibleintheirnationalandre

18、gionalstandards.Any divergencebetweentheIECStandardandthecorrespondingnationalorregionalstandardshallbeclearly indicatedinthelatter. 5) TheIECprovidesnomarkingproceduretoindicateitsapprovalandcannotberenderedresponsibleforany equipmentdeclaredtobeinconformitywithoneofitsstandards. 6) Attentionisdraw

19、ntothepossibilitythatsomeoftheelementsofthisInternationalStandardmaybethesubject ofpatentrights.TheIECshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights. InternationalStandardIEC61847hasbeenpreparedbyIECtechnicalcommittee87: Ultrasonics. Thetextofthisstandardisbasedonthefollowingdocumen

20、ts: FDIS Reportonvoting 87/114/FDIS 87/117/RVD Fullinformationonthevotingfortheapprovalofthisstandardcanbefoundinthereporton votingindicatedintheabovetable. AnnexesA,BandCareforinformationonly. Inthisstandardthefollowingprinttypesareused: Requirements:inromantype Testspecifications:initalictype Note

21、s:insmallromantype Wordsin boldinthetextaredefinedinclause3. Abilingualversionofthisstandardmaybeissuedatalaterdate.4 61847IEC:1998(E) INTRODUCTION Ultrasonicsurgicalsystems,operatinginthe20kHzto60kHzrange,areusedwidelyin ophthalmologyandneurosurgerytofragmentordisintegrateandaspirateunwantedtissue.

22、 Theircommercialuseinophthalmologystartedin1970.Theirapplicationinneurosurgery followedabout10yearslater.Ultrasonicsurgicalsystemsarealsowidelyusedinoncology surgery. ThisInternationalStandarddefinestheparameterswhichcharacterizetheoutputand performanceofopenandclosedsiteultrasonicsurgicalsystems,an

23、dindicateswhich parametersshouldbedeclared.Inaddition,measurementproceduresaredescribedsothat technicallyqualifiedpeoplewillbeabletoreportontheparametersinauniformand understandablefashion.Anopensurgicalsiteisoneinwhichtheincisionislargerelativeto thesizeoftheapplicatortipbeinginsertedthusprecluding

24、anyincreaseinpressureofthe organduetoanimbalanceofirrigantflowandsuctionflow.Anexampleofaclosedsurgical siteisaneyewheretheincisioniscloselycontrolled. ThisInternationalStandarddoesnotprovideanyguidanceonwhatistheresultantsafetyor efficacyofdevicesdescribedbytheseparameterssinceverylittlescientifica

25、llycontrolleddata areavailablebywhichsuchjudgementscanbemade.61847IEC:1998(E) 5 ULTRASONICSSURGICALSYSTEMS Measurementanddeclarationofthebasicoutputcharacteristics 1Scope ThisInternationalStandardspecifies: theessentialnonthermaloutputcharacteristicsofultrasonicsurgicalunits; NOTE1Oneoftheparameters

26、ofinterestisoutputacousticpower.Thisstandardaddressesonlythelow frequency(under100kHz)componentofthetotaldeliveredenergy.Thehighfrequencycomponent,whichprobably relatestocavitationdevelopedatthetip,isnotaddressed(seeA.4). methodsofmeasurementoftheseoutputcharacteristics; thosecharacteristicswhichsho

27、uldbedeclaredbythemanufacturersofsuchequipment. NOTE2Intheinterestofclarity,thisstandarddoesnotaddressallofthecomplexsurfacesandshapespossible forapplicatortips .Astraighttubularshapeisusedinthedescriptionoftheparametersandmeasurementstobe made.Itislefttotheuserofthisstandardtoadaptthebasicmethodolo

28、gydescribedtomorecomplexdesignsif required. ThisInternationalStandardisapplicabletoequipmentwhichmeetstherequirementsofa,b andcbelow: a) ultrasonicsurgicalsystemsoperatinginthefrequencyrange20kHzto60kHz;and b) ultrasonicsurgicalsystems,whoseuseisthefragmentationorcuttingofhumantissue, whetherornotth

29、oseeffectsaredeliveredinconjunctionwithtissueremovalorcoagulation; and c) ultrasonicsurgicalsystems,inwhichanacousticwaveisconductedbymeansofa specificallydesignedwaveguidetodeliverenergytothesurgicalsite. NOTE3Examplesofthesetypesofsystemsaresurgicalaspirators,intracorporeallithotripters,endcutting

30、 devicesetc. ThisInternationalStandardisnotapplicableto: lithotripsyequipmentwhichusesextracorporeallyinducedpressurepulses,focussed throughliquidconductingmediaandthesofttissuesofthebody; surgicaldevicesusedaspartofthetherapeuticprocess(hyperthermiasystems); surgicaldeviceswhoseacousticapplicationa

31、reasarenotattheendofalongitudinally vibratingapplicatortipandthereforewouldnotfitthemonopolemodelusedinthisstandard. ThisInternationalStandarddoesnotdealwiththeeffectivenessorsafetyofultrasonicsurgical systems. NOTE4Throughoutthisstandard,thetermaccuracymeanstheoveralluncertaintyexpressedatthe95% co

32、nfidencelevel. 2 Normativereferences Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext, constituteprovisionsofthisInternationalStandard.Atthetimeofpublication,theeditions indicatedwerevalid.Allnormativedocumentsaresubjecttorevision,andpartiesto agreementsbasedonthisInte

33、rnationalStandardareencouragedtoinvestigatethepossibility ofapplyingthemostrecenteditionsofthenormativedocumentsindicatedbelow.Membersof IECandISOmaintainregistersofcurrentlyvalidInternationalStandards. IEC60500:1974, IECstandardhydrophone IEC61205:1993, UltrasonicsDentaldescalersystemsMeasurementan

34、ddeclarationofthe outputcharacteristics6 61847IEC:1998(E) 3Definitions ForthepurposeofthisInternationalStandard,thefollowingdefinitionsapply. 3.1 applicatortip;appliedpart thatpartofthesurgicaltoolwhichcomesintodirectcontactwithbodytissues 3.2 directivitypattern normalizedvariationinacousticpressure

35、asafunctionofangleatconstantrangefromthe applicatortip NOTEThisparameterisimportantwhenoperatingadjacenttobodystructureswhicharesensitivetopressure andmotionsuchastheendothelialcellsontheinsideofthecorneaoracousticnerves. Symbol: p fd Unit:dimensionlessplot 3.3 drivefrequency meanfrequencyofthedrivi

36、ngvoltageorcurrent NOTEThisparameter,coupledwithtipvibrationexcursion,allowstheusertocomparethevelocitiesofapplicator tips. Symbol: f d Unit:kilohertz,kHz 3.4 dutycycle forthosesystemswhichmodulatetheelectricaldrivepower,theratioofthevoltageorcurrent pulseduration(ontime)tothedurationofonecompletemo

37、dulationcyclewhiletheequipment isactive Symbol: D cy Unit:dimensionless 3.5 maximumelectricalpower thepeakinputelectricalpowertotheultrasonichandpiecewhentheloadonthe applicatortip isgraduallyincreasedfromitsquiescentcondition NOTEThepeakelectricalpoweroccursatthepointatwhichareductioninthe primaryt

38、ipvibrationexcursion fromitsvaluecorrespondingtothe quiescentelectricalpower occurs(see6.9and6.10). Symbol: P max Unit:watts,W 3.6 outputacousticpower theacousticpowerdeliveredbythe applicatortipintowater,andmeasuredusinga calorimetricmethod(see6.5) NOTEMeasurementofacousticpowerdeliveredby applicat

39、ortips havingdifferentoutputareasand/orexcursion amplitudeswillfacilitateapplicationoftheALARAprinciple,theuseofexposurelevelsthatareaslowas reasonablyachievable. Symbol: P a Unit:milliwatts,mW61847IEC:1998(E) 7 3.7 derivedoutputacousticpower theacousticpowerdeliveredbythe applicatortip intowater,an

40、dderivedfrommeasurements madeusingahydrophone(see6.5) NOTEMeasurementofacousticpowerdeliveredby applicatortips havingdifferentoutputareasand/orexcursion amplitudeswillfacilitateapplicationoftheALARAprinciple,theuseofexposurelevelsthatareaslowas reasonablyachievable. Symbol: P ad Unit:milliwatts,mW 3

41、.8 powerreserveindex theratioof maximumelectricalpower to quiescentelectricalpower NOTE1The powerreserveindex givestheuserameasureofhowmuch“extra”powerisavailabletomaintaina constanttipexcursionamplitudeundervariousloadconditions. Symbol: P i Unit:dimensionless NOTE2The powerreserveindex willonlyall

42、owdirectcomparisonofdifferentdevicesifthosedevicessharethe sameoperatingmodality.Piezoelectricandmagnetostrictivedevicescannotbevalidlycomparedusingthe power reserveindex . 3.9 primaryacousticoutputarea theareaoftheprojectionofthesolidpartofthe applicatortip inthedirectionof primarytip vibrationexcu

43、rsion NOTE Primaryacousticoutputarea isusedindeterminingtheenergyradiatedfromtheendofan applicator tipfordifferenttipsoperatingatthesamevibrationexcursionandfrequency. Symbol: A ap Unit:squaremillimetres,mm 2 3.10 primarytipvibrationexcursion peaktopeakdisplacementofthe applicatortipinthedirectionofmaximumamplitude,ata pointonthe applicatortip notmorethan1mmfromi