1、INTERNATIONAL STANDARD IEC 61846 Firstedition 199804 Ultrasonics Pressurepulselithotripters Characteristicsoffields Ultrasons Lithotripteursondesdepression Caractrisationdeschamps Referencenumber IEC61846:1998(E)Numbering Asfrom1January1997allIECpublicationsareissuedwithadesignationinthe 60000series
2、. Consolidatedpublications ConsolidatedversionsofsomeIECpublicationsincludingamendmentsare available.Forexample,editionnumbers1.0,1.1and1.2refer,respectively,tothe basepublication,thebasepublicationincorporatingamendment1andthebase publicationincorporatingamendments1and2. Validityofthispublication T
3、hetechnicalcontentofIECpublicationsiskeptunderconstantreviewbytheIEC, thusensuringthatthecontentreflectscurrenttechnology. Informationrelatingtothedateofthereconfirmationofthepublicationisavailable intheIECcatalogue. Informationonthesubjectsunderconsiderationandworkinprogressundertakenby thetechnica
4、lcommitteewhichhaspreparedthispublication,aswellasthelistof publicationsissued,istobefoundatthefollowingIECsources: IECwebsite* CatalogueofIECpublications Publishedyearlywithregularupdates (Onlinecatalogue)* IECBulletin AvailablebothattheIECwebsite*andasaprintedperiodical Terminology,graphicalandlet
5、tersymbols Forgeneralterminology,readersarereferredtoIEC 60050: International ElectrotechnicalVocabulary (IEV). Forgraphicalsymbols,andlettersymbolsandsignsapprovedbytheIECfor generaluse,readersarereferredtopublicationsIEC60027: Lettersymbolstobe usedinelectricaltechnology,IEC60417:Graphicalsymbolsf
6、oruseonequipment. Index,surveyandcompilationofthesinglesheets and IEC60617: Graphicalsymbols fordiagrams. * Seewebsiteaddressontitlepage.INTERNATIONAL STANDARD IEC 61846 Firstedition 199804 Ultrasonics Pressurepulselithotripters Characteristicsoffields Ultrasons Lithotripteursondesdepression Caractr
7、isationdeschamps CommissionElectrotechniqueInternationale InternationalElectrotechnicalCommission IEC1998Copyrightallrightsreserved Droitsdereproductionrservs Aucunepartiedecettepublicationnepeuttrereproduiteni utilisesous quelqueformequecesoitetparaucun procd,lectroniqueoumcanique,ycomprislaphoto c
8、opieetlesmicrofilms,sanslaccordcritdelditeur. Nopartofthispublicationmaybereproducedorut ilizedin anyformorbyanymeans,electronicormechanical, includingphotocopyingandmicrofilm,withoutpermissionin writingfromthepublisher. InternationalElectrotechnicalCommission 3,ruedeVarembGeneva,Switzerland Telefax
9、:+41229190300 email:inmailiec.ch IECwebsitehttp:/www.iec.ch PRICECODE M Forprice,seecurrentcatalogue2 61846IEC:1998(E) CONTENTS Page FOREWORD . 3 INTRODUCTION . 4 Clause 1Scope. 5 2Normative references 5 3Definitions 6 4 Listofsymbols 10 5 Conditionsofmeasurement 10 6Test equipment. 11 6.1 Testchamb
10、er. 11 6.2 Hydrophone . 11 6.3 Voltagemeasurement 12 7Measurement procedure. 12 7.1 Spatialmeasurements . 12 7.2 Temporalmeasurements . 14 7.3 Acousticenergymeasurements 14 Annexes A Acousticwavelithotripsy. 16 B Typesofpressurewavetransducers . 18 C Fieldmeasurement . 20 D Bibliography 2561846IEC:1
11、998(E) 3 INTERNATIONALELECTROTECHNICALCOMMISSION _ ULTRASONICS PRESSUREPULSELITHOTRIPTERS CHARACTERISTICSOFFIELDS FOREWORD 1) TheIEC(InternationalElectrotechnicalCommission)isaworldwideorganizationforstandardizationcomprising allnationalelectrotechnicalcommittees(IECNationalCommittees).Theobjectofth
12、eIECistopromote internationalcooperationonallquestionsconcerningstandardizationintheelectricalandelectronicfields.To thisendandinadditiontootheractivities,theIECpublishesInternationalStandards.Theirpreparationis entrustedtotechnicalcommittees;anyIECNationalCommitteeinterestedinthesubjectdealtwithmay
13、 participateinthispreparatorywork.International,governmentalandnongovernmentalorganizationsliaising withtheIECalsoparticipateinthispreparation.TheIECcollaboratescloselywiththeInternationalOrganization forStandardization(ISO)inaccordancewithconditionsdeterminedbyagreementbetweenthetwo organizations.
14、2) TheformaldecisionsoragreementsoftheIEContechnicalmattersexpress,asnearlyaspossible,an internationalconsensusofopinionontherelevantsubjectssinceeachtechnicalcommitteehasrepresentation fromallinterestedNationalCommittees. 3) Thedocumentsproducedhavetheformofrecommendationsforinternationaluseandarep
15、ublishedintheform ofstandards,technicalreportsorguidesandtheyareacceptedbytheNationalCommitteesinthatsense. 4) Inordertopromoteinternationalunification,IECNationalCommitteesundertaketoapplyIECInternational Standardstransparentlytothemaximumextentpossibleintheirnationalandregionalstandards.Any diverg
16、encebetweentheIECStandardandthecorrespondingnationalorregionalstandardshallbeclearly indicatedinthelatter. 5) TheIECprovidesnomarkingproceduretoindicateitsapprovalandcannotberenderedresponsibleforany equipmentdeclaredtobeinconformitywithoneofitsstandards. 6) Attentionisdrawntothepossibilitythatsomeo
17、ftheelementsofthisInternationalStandardmaybethesubject ofpatentrights.TheIECshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights. InternationalStandardIEC61846hasbeenpreparedbyIECtechnicalcommittee87: Ultrasonics. Thetextofthisstandardisbasedonthefollowingdocuments: FDIS Reportonvoting 87
18、/115/FDIS 87/118/RVD Fullinformationonthevotingfortheapprovalofthisstandardcanbefoundinthereporton votingindicatedintheabovetable. AnnexesA,B,CandDareforinformationonly. Inthisstandard,thefollowingprinttypesareused: requirementsanddefinitions:inromantype; NOTES:insmallerromantype; compliance:initali
19、ctype; termsusedthroughoutthisstandardwhichhavebeendefinedinclause3:smallcase romanboldtype . Abilingualversionofthisstandardmaybeissuedatalaterdate.4 61846IEC:1998(E) INTRODUCTION Extracorporeallithotripsyisusedfortheclinicaltreatmentofrenal,uretericandbiliarystones. Lithotripsyemployshighintensity
20、acousticwavestoproducedisintegrationofthestones throughaprocessofsequentialapplicationofpressurewaves.Severaldifferentformsof lithotripsyequipmentarenowcommerciallyavailablefromanumberofmanufacturers. ThisInternationalStandardspecifiesmethodsofmeasuringandcharacterizingtheacoustic pressurefieldgener
21、atedbylithotripsyequipment.61846IEC:1998(E) 5 ULTRASONICS PRESSUREPULSELITHOTRIPTERS CHARACTERISTICSOFFIELDS 1Scope ThisInternationalStandardisapplicableto lithotripsyequipment usingextracorporeallyinducedpressurewaves; lithotripsyequipment producingfocusedmechanicalenergy. ThisInternationalStandard
22、doesnotapplytopercutaneousandlaser lithotripsyequipment . ThisInternationalStandardspecifies measurableparameterswhichcouldbeusedinthedeclarationoftheacousticoutputof extracorporeal lithotripsyequipment , methodsofmeasurementandcharacterizationofthepressurefieldgeneratedby lithotripsyequipment . NOT
23、ETheparametersdefinedinthisInternationalStandarddonotatthepresenttimeallowquantitative statementstobemadeabouteffectivenessandpossiblehazard.Inparticular,itisnotpossibletomakea statementaboutthelimitsfortheseeffects. Whilethisparticularstandardhasbeendevelopedforequipmentintendedforusein lithotripsy
24、,ithasbeendevelopedsuchthat,aslongasnootherspecificstandardsare availabletobeusedforothermedicalapplicationsoftherapeuticextracorporeal pressure pulseequipment,thisstandardmaybeusedasaguideline. 2 Normativereferences Thefollowingnormativedocumentscontainprovisionswhich,throughreferenceinthistext, co
25、nstituteprovisionsofthisInternationalStandard.Atthetimeofpublication,theeditions indicatedwerevalid.Allnormativedocumentsaresubjecttorevision,andpartiesto agreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibility ofapplyingthemostrecenteditionsofthenormativedocumentsindicate
26、dbelow.Membersof IECandISOmaintainregistersofcurrentlyvalidInternationalStandards. IEC60050(801):1994, InternationalElectrotechnicalVocabulary(IEV)Chapter801:Acoustics andelectroacoustics IEC60866:1987, Characteristicsandcalibrationofhydrophonesforoperationinthefrequency range0,5MHzto15MHz IEC61102:
27、1991, Measurementandcharacterisationofultrasonicfieldsusinghydrophonesin thefrequencyrange0,5MHzto15MHz6 61846IEC:1998(E) 3Definitions ForthepurposeofthisInternationalStandard,thefollowingdefinitionsapply. 3.1 acousticpulseenergy 3.1.1 derivedacousticpulseenergy spatialintegralofthe derivedpulseinte
28、nsityintegral overacircularcrosssectionalareaof radius R inthe xy planewhichcontainsthe focus Symbol: E R Unit:joule,J 3.1.2 derivedfocalacousticpulseenergy spatialintegralofthe derivedpulseintensityintegral overthe focalcrosssectionalarea Symbol: E f Unit:joule,J NOTEThisdefinitionmayoverestimate E
29、iftheapertureofthe pressurepulse generatorislarge. 3.2 beamaxis linepassingthroughthegeometriccentreoftheapertureofthe pressurepulse generatorand the focus NOTEThislineistakenasthe z axis.See6.1andclause7. 3.3 compressionalpulseduration timeintervalbeginningatthefirsttimethe instantaneousacousticpre
30、ssure exceeds50%of thepeakpositiveacousticpressureandendingatthenexttimethe instantaneous acousticpressure hasthatvalue(seefigureC.1) Symbol: t FWHMp+ Unit:second,s NOTEThesubscript“FWHM“standsfor“fullwidth,halfmaximum“. 3.4 derivedpulseintensityintegral timeintegralofthe instantaneousintensity atap
31、articularpointina pressurepulse fieldover the pressurepulsewaveform (see3.31ofIEC61102) Symbol: PII Unit:joulepermetresquared,J/m 2 3.5 endofcableloadedsensitivityofahydrophone ratioofthevoltageattheendofanyintegralcableorconnectorofahydrophone,when connectedtoaspecifiedelectricalinputimpedance,toth
32、e instantaneousacousticpressure intheundisturbedfreefieldofaplanewaveinthepositionoftheacousticcentreofthe hydrophoneifthe hydrophonewereremoved(see3.14ofIEC61102) Symbol: M L Unit:voltperpascal,VPa 161846IEC:1998(E) 7 3.6 focalcrosssectionalarea areaofthepeakcompressionalacousticpressure contourwhi
33、chis6dBrelativetothe valueatthefocusandisintheplane,perpendiculartothe beamaxis,whichcontainsthe focus Symbol: A f Unit:metresquared,m 2 3.7 focalextent shortestdistancealongthe zaxisthatconnectspointsonthe6dBcontourof peakpositive acousticpressure inthe xz planeoneithersideofthe focus Symbol: f z U
34、nit:metre,m 3.8 focalvolume volumeinspacecontainedwithinthesurfacedefinedbythe6dB(relativetothevalueatthe focus) peakcompressionalacousticpressure contoursmeasuredaroundthe focus Symbol: V f Unit:metrecubed,m 3 NOTEItisdifficulttomeasure6dBpointsthroughoutthevolumearoundthe focus.Itisreasonableinpra
35、ctice toapproximatethe focalvolume frommeasurementstakeninthreeorthogonaldirections:the beamaxis ( zaxis); thedirectionofmaximumbeamdiameter( x axis);theaxisperpendiculartothe x axis( y axis). 3.9 focalwidth,maximum maximumwidthofthe6dBcontourof p + aroundthe focusinthe xyplanewhichcontains thefocus
36、 Symbol: f x Unit:metre,m 3.10 focalwidth,orthogonal widthofthe6dBcontourof p + aroundthe focus,inthe xyplanewhichcontainsthe focus, inthedirectionperpendicularto f x Symbol: f y Unit:metre,m 3.11 focus locationinthe pressurepulse fieldofthemaximum peakpositiveacousticpressure 3.12 hydrophone transd
37、ucerthatproduceselectricalsignalsinresponsetowaterborneacousticsignals IEV8013226(seealsoIEC60866)8 61846IEC:1998(E) 3.13 instantaneousacousticpressure pressureminustheambientpressureataparticularinstantintimeandataparticularpointin anacousticfield(seealso8012119ofIEC60050(801) Symbol: p Unit:pascal
38、,Pa 3.14 instantaneousintensity acousticenergytransmittedperunittimeinthedirectionofacousticwavepropagationperunit areanormaltothisdirectionataparticularinstantintimeandataparticularpointinan acousticfield Formeasurementpurposesreferredtointhisstandard,wherefarfieldconditionsmaybe assumed,the instan
39、taneousintensity , I,isexpressedas: I p Z = 2 where p isthe instantaneousacousticpressure ; Z isthecharacteristicacousticimpedanceofthemedium. (Seealso3.21ofIEC61102.) Symbol: I Unit:wattpermetresquared,W/m 2 3.15 lithotripsyequipment devicefordisintegratingcalculiandotherconcretionswithinthebody NO
40、TEKnownapplicationsincluderenalstones,gallstones,pancreaticductstones,salivarystones,orthopaedic painandcalcificationintendons. 3.16 peaknegativeacousticpressure,peakrarefactionalacousticpressure maximumofthemodulusoftherarefactionalacousticpressureatanyspatiallocationinthe pressurepulse field(see3.
41、26ofIEC61102) Symbol: p Unit:pascal,Pa 3.17 peakpositiveacousticpressure,peakcompressionalacousticpressure maximumcompressionalacousticpressureatanyspatiallocationinthe pressurepulsefield (see3.27ofIEC61102) Symbol: p + Unit:pascal,Pa 3.18 pressurepulse acousticwaveemittedbythe lithotripsyequipment6
42、1846IEC:1998(E) 9 3.19 pressurepulsewaveform temporalwaveformoftheinstantaneousacousticpressureataspecifiedpositionina pressurepulsefieldanddisplayedoveraperiodsufficientlylongtoincludeallsignificant acousticinformationinthe pressurepulse 3.20 pulsepressuresquaredintegral timeintegralofthesquareofth
43、einstantaneousacousticpressureoverthepressurepulse waveform Symbol: p i Unit:pascalsquaredseconds 3.21 risetime atthe focus,timetakenforthe instantaneousacousticpressure toincreasefrom10%to 90%ofthe peakpositiveacousticpressure (seefigureC.1) Symbol: t r Unit:second,s 3.22 targetlocation locationinspacewherethemanufacturerintendstheusertolocatethecalculi 3.23 tempor
