IEC 60601-2-11-1997 医用电气设备第2-11部分:γ射束治疗设备安全专用要求
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【英文标准名称】:Medicalelectricalequipment-Part2:Particularrequirementsforthesafetyofgammabeamtherapyequipment
【原文标准名称】:医用电气设备第2-11部分:γ射束治疗设备安全专用要求
【标准号】:IEC60601-2-11-1997
【标准状态】:现行
【国别】:国际
【发布日期】:1997-08
【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/SC62C
【标准类型】:()
【标准水平】:()
【中文主题词】:电气工程;治疗设备;医疗设备;安全要求;γ辐射;安全;电气器具;规范(验收)
【英文主题词】:Acceptanceinspection;Accompanyingforms;Bearings;Blasting;Contactsafetydevices;Controls;Definitions;Density;Design;Designations;Dielectricstrength;Documentations;Dose;Electricappliances;Electriccontactprotection;Electriccontacts;Electricpowersystems;Electricshock;Electricalengineering;Electricalequipment;Electricalmedicalequipment;Electricalsafety;Electromedicine;Enclosures;Environment;Environmentalcondition;Environmentalconditions;Environmentaltesting;Equipment;Equipmentsafety;Explosionhazard;Fire;Firehazards;Firerisks;Gamma-irradiationfacility;Gamma-radiation;Gamma-rayapparatus;Handling;Hydraulics;Identification;Inscription;Inspection;Inspectionspecification;Instruments;Irradiance;Irradiationapparatus;Leaktests;Marking;Measurement;Medicalequipment;Medicalradiology;Medicalsciences;Medicaltechnology;Motion;Motionalarea;Operation;Operationalinstructions;Patients;People;Performance;Persons;Phototherapy;Plant;Pneumatics;Processengineering;Production;Projectors;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Radiation;Radiationprotection;Radioactivesources;Radiology;Radiologyapparatus(medical);Radionuclides;Radiotherapy;Regulatorsoftemperature;Rules;Safety;Safetycircuits;Safetyengineering;Safetyrequirements;Shields;Specification(approval);Stress;Surveillance(approval);Switches;Temperature;Temperaturecontrollers;Terms;Testreports;Testing;Therapyequipment;Time;Transport;Typeoftest;Usefulbeam;Warningsymbols;X-rays
【摘要】:Addition:aa)ThisParticularStandardspecifiesrequirementsforthesafetyofGAMMABEAMTHERAPYEQUIPMENTintendedforRADIOTHERAPYinhumanmedicalpracticeandincludesEQUIPMENTinwhichtheselectionandDISPLAYofoperatingparameterscanbecontrolledbyaPROGRAMMABLEELECTRONICSYSTEM(PES).bb)ThisParticularStandardappliestoEQUIPMENTwhichisintendedtodeliveraGAMMARADIATIONBEAM(S)atNORMALTREATMENTDISTANCESgreaterthan5cmusingaSEALEDRADIOACTIVESOURCE(S).ForEQUIPMENToperatingatshorterdistances,specialprecautionsmaybenecessary.cc)ThisParticularStandardappliestoEQUIPMENTintendedtobe:-usedundertheauthorityofappropriatelylicensedorQUALIFIEDPERSONS,byOPERATORShavingtheskillsrequiredforaparticularmedicalapplicationandactinginaccordancewiththeINSTRUCTIONSFORUSE,-maintainedatpredeterminedintervals,-subjecttoregularchecksbytheuser,-usedforparticularspecifiedclinicalpurposese.g.STATIONARYRADIOTHERAPYorMOVINGBEAMRADIOTHERAPY.dd)ThisParticularStandardisapplicabletothemanufactureandsomeinstallationaspectsofGAMMABEAMTHERAPYEQUIPMENTbytheinclusionofTYPETESTSandSITETESTSrespectively.ee)ThisParticularStandardspecifiestherequirementsforEQUIPMENT.ItdoesnotspecifytherequirementsfortheRADIATIONSOURCES.
【中国标准分类号】:C43
【国际标准分类号】:11_040_50;13_280
【页数】:95P.;A4
【正文语种】:英语
【原文标准名称】:医用电气设备第2-11部分:γ射束治疗设备安全专用要求
【标准号】:IEC60601-2-11-1997
【标准状态】:现行
【国别】:国际
【发布日期】:1997-08
【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/SC62C
【标准类型】:()
【标准水平】:()
【中文主题词】:电气工程;治疗设备;医疗设备;安全要求;γ辐射;安全;电气器具;规范(验收)
【英文主题词】:Acceptanceinspection;Accompanyingforms;Bearings;Blasting;Contactsafetydevices;Controls;Definitions;Density;Design;Designations;Dielectricstrength;Documentations;Dose;Electricappliances;Electriccontactprotection;Electriccontacts;Electricpowersystems;Electricshock;Electricalengineering;Electricalequipment;Electricalmedicalequipment;Electricalsafety;Electromedicine;Enclosures;Environment;Environmentalcondition;Environmentalconditions;Environmentaltesting;Equipment;Equipmentsafety;Explosionhazard;Fire;Firehazards;Firerisks;Gamma-irradiationfacility;Gamma-radiation;Gamma-rayapparatus;Handling;Hydraulics;Identification;Inscription;Inspection;Inspectionspecification;Instruments;Irradiance;Irradiationapparatus;Leaktests;Marking;Measurement;Medicalequipment;Medicalradiology;Medicalsciences;Medicaltechnology;Motion;Motionalarea;Operation;Operationalinstructions;Patients;People;Performance;Persons;Phototherapy;Plant;Pneumatics;Processengineering;Production;Projectors;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Radiation;Radiationprotection;Radioactivesources;Radiology;Radiologyapparatus(medical);Radionuclides;Radiotherapy;Regulatorsoftemperature;Rules;Safety;Safetycircuits;Safetyengineering;Safetyrequirements;Shields;Specification(approval);Stress;Surveillance(approval);Switches;Temperature;Temperaturecontrollers;Terms;Testreports;Testing;Therapyequipment;Time;Transport;Typeoftest;Usefulbeam;Warningsymbols;X-rays
【摘要】:Addition:aa)ThisParticularStandardspecifiesrequirementsforthesafetyofGAMMABEAMTHERAPYEQUIPMENTintendedforRADIOTHERAPYinhumanmedicalpracticeandincludesEQUIPMENTinwhichtheselectionandDISPLAYofoperatingparameterscanbecontrolledbyaPROGRAMMABLEELECTRONICSYSTEM(PES).bb)ThisParticularStandardappliestoEQUIPMENTwhichisintendedtodeliveraGAMMARADIATIONBEAM(S)atNORMALTREATMENTDISTANCESgreaterthan5cmusingaSEALEDRADIOACTIVESOURCE(S).ForEQUIPMENToperatingatshorterdistances,specialprecautionsmaybenecessary.cc)ThisParticularStandardappliestoEQUIPMENTintendedtobe:-usedundertheauthorityofappropriatelylicensedorQUALIFIEDPERSONS,byOPERATORShavingtheskillsrequiredforaparticularmedicalapplicationandactinginaccordancewiththeINSTRUCTIONSFORUSE,-maintainedatpredeterminedintervals,-subjecttoregularchecksbytheuser,-usedforparticularspecifiedclinicalpurposese.g.STATIONARYRADIOTHERAPYorMOVINGBEAMRADIOTHERAPY.dd)ThisParticularStandardisapplicabletothemanufactureandsomeinstallationaspectsofGAMMABEAMTHERAPYEQUIPMENTbytheinclusionofTYPETESTSandSITETESTSrespectively.ee)ThisParticularStandardspecifiestherequirementsforEQUIPMENT.ItdoesnotspecifytherequirementsfortheRADIATIONSOURCES.
【中国标准分类号】:C43
【国际标准分类号】:11_040_50;13_280
【页数】:95P.;A4
【正文语种】:英语
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