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【英文标准名称】:ElectrosurgicalDevices
【原文标准名称】:电手术装置
【标准号】:ANSI/AAMIHF18-1993
【标准状态】:作废
【国别】:美国
【发布日期】:1993-09-17
【实施或试行日期】:
【发布单位】:美国国家标准学会(ANSI)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:医疗设备;规范(验收);手术器械
【英文主题词】:medicalequipment;specification(approval);surgicalinstruments
【摘要】:Thisstandardestablishesminimumsafetyandperformancerequirementsforelectrosurgicalsystems.Anelectrosurgicalsystemconsistsofahigh-frequencyelectrical-currentgenerator,cables,electrodes,andsafetydevicesfordeliveringthishigh-frequencyelectrosurgery.Thesystemincludesthecircuitryanddevicesneededtocontroltheduration,modeofoperation,andintensityoftheapplication.Includedwithinthescopeofthisstandardareelectrosurgicalportionofmultifunctiondevices.Examplesofdeviceswithinthescopeofthisstandardareelectrosurgicalhigh-frequencygeneratorsanddirectlyrelatedaccessories,includingactiveelectrodesandcables,dispersiveelectrodesandcables,andfootswitchesorotheroperator-controlledmechanismsforactivatingthegeneratoroutput.NOTE-Whenitisnecessarytocreateproductstanardsforspecialtydevices(e.g.,neurologicallesiongenerators,depilationunits,endoscopicdevicescombiningafiber-opticlightsourceorgasinsufflatorwiththeelectrosurgicalgenerator),appropriate,applicablerequirementsfortheelectrosurgicalportionoftheunitanditsaccessoriesmaybenecessary.
【中国标准分类号】:C39
【国际标准分类号】:11_040_30
【页数】:44P;A4
【正文语种】:英语