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【英文标准名称】:Ultrasonics-Surgicalsystems-Measurementanddeclarationofthebasicoutputcharacteristics
【原文标准名称】:超声学外科装置基本输出特性的测量和标示
【标准号】:IEC61847-1998
【标准状态】:现行
【国别】:国际
【发布日期】:1998-01
【实施或试行日期】:
【发布单位】:国际电工委员会(IX-IEC)
【起草单位】:IEC/TC87
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗技术学;外科学;超声波学;输出量;超声波装置;额定值;电气工程;输出测定;电功率测量;测量技术;定义;测量
【英文主题词】:Definitions;Electricalengineering;Measurement;Measuringtechniques;Medicaltechnology;Outputdetermination;Outputquantities;Powermeasurement(electric);Ratings;Surgery;Ultrasonicdevices;Ultrasonics
【摘要】:ThisInternationalStandardspecifies:-theessentialnon-thermaloutputcharacteristicsofultrasonicsurgicalunits;NOTE1-Oneoftheparametersofinterestisoutputacousticpower.Thisstandardaddressesonlythelow-frequency(under100kHz)componentofthetotaldeliveredenergy.Thehigh-frequencycomponent,whichprobablyrelatestocavitationdevelopedatthetip,isnotaddressed(seeA.4).-methodsofmeasurementoftheseoutputcharacteristics;-thosecharacteristicswhichshouldbedeclaredbythemanufacturersofsuchequipment.NOTE2-Intheinterestofclarity,thisstandarddoesnotaddressallofthecomplexsurfacesandshapespossibleforapplicatortips.Astraighttubularshapeisusedinthedescriptionoftheparametersandmeasurementstobemade.Itislefttotheuserofthisstandardtoadaptthebasicmethodologydescribedtomorecomplexdesignsifrequired.ThisInternationalStandardisapplicabletoequipmentwhichmeetstherequirementsofa,bandcbelow:a)ultrasonicsurgicalsystemsoperatinginthefrequencyrange20kHzto60kHz;andb)ultrasonicsurgicalsystems,whoseuseisthefragmentationorcuttingofhumantissue,whetherornotthoseeffectsaredeliveredinconjunctionwithtissueremovalorcoagulation;andc)ultrasonicsurgicalsystems,inwhichanacousticwaveisconductedbymeansofaspecificallydesignedwaveguidetodeliverenergytothesurgicalsite.NOTE3-Examplesofthesetypesofsystemsaresurgicalaspirators,intracorporeallithotripters,end-cuttingdevicesetc.ThisInternationalStandardisnotapplicableto:-lithotripsyequipmentwhichusesextracorporeallyinducedpressurepulses,focussedthroughliquidconductingmediaandthesofttissuesofthebody;-surgicaldevicesusedaspartofthetherapeuticprocess(hyperthermiasystems);-surgicaldeviceswhoseacousticapplicationareasarenotattheendofalongitudinallyvibratingapplicatortipandthereforewouldnotfitthemonopolemodelusedinthisstandard.ThisInternationalStandarddoesnotdealwiththeeffectivenessorsafetyofultrasonicsurgicalsystems.NOTE4-Throughoutthisstandard,thetermaccuracymeanstheoveralluncertaintyexpressedatthe95%confidencelevel.
【中国标准分类号】:C41
【国际标准分类号】:11_040_60
【页数】:31P.;A4
【正文语种】:英语