BS EN 60601-1-6-2010 医用电气设备.基本安全性和基本性能的一般要求.并列标准.可用性
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【英文标准名称】:Medicalelectricalequipment-Generalrequirementsforbasicsafetyandessentialperformance-Collateralstandard-Usability
【原文标准名称】:医用电气设备.基本安全性和基本性能的一般要求.并列标准.可用性
【标准号】:BSEN60601-1-6-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-05-31
【实施或试行日期】:2010-05-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Accidentprevention;Anaesthesiology;Classesofprotection;Classification;Colourcodes;Definitions;Design;Dimensions;Earthconductors;Earthing;Electriccontactprotection;Electricenclosures;Electricmains;Electricpowersystems;Electricshocks;Electricalaccidents;Electricalengineering;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electrically-operateddevices;Electromagneticcompatibility;Electromedicine;Electrostatics;EMC;Enclosures;Environmentalconditions;Equipmentsafety;Explosionprotection;Firesafety;Fitnessforpurpose;Graphicsymbols;Hazards;Inspection;Instructionsforuse;Insulatingenclosures;Insulations;Lists;Marking;Measurement;Measuringtechniques;Mechanicalsafety;Medicalequipment;Medicalradiology;Medicalsciences;Medicaltechnology;Occupationalsafety;Operationalinstructions;Protectionagainstelectricshocks;Protectioncoverings;Qualificationtests;Radiationprotection;Riskanalysis;Safety;Safetydevices;Safetyengineering;Safetyregulations;Safetyrequirements;Specification(approval);Strengthofmaterials;Surveys;Symbols;Testatmospheres;Testing;Testingconditions;Transformers
【摘要】:ThisInternationalStandardspecifiesaPROCESSforaMANUFACTURERtoanalyse,specify,design,VERIFYandVALIDATEUSABILITY,asitrelatestoBASICSAFETYandESSENTIALPERFORMANCEofMEDICALELECTRICALEQUIPMENT,hereafterreferredtoasMEEQUIPMENT.ThisUSABILITYENGINEERINGPROCESSassessesandmitigatesRISKScausedbyUSABILITYproblemsassociatedwithCORRECTUSEandUSEERRORS,i.e.,NORMALUSE.ItcanbeusedtoidentifybutdoesnotassessormitigateRISKSassociatedwithABNORMALUSE.IftheUSABILITYENGINEERINGPROCESSdetailedinthiscollateralstandardhasbeencompliedwithandtheacceptancecriteriadocumentedintheUSABILITYVALIDATIONplanhavebeenmet(see5.9ofIEC62366:2007),thentheRESIDUALRISKS,asdefinedinISO14971,associatedwithUSABILITYofMEEQUIPMENTarepresumedtobeacceptable,unlessthereisOBJECTIVEEVIDENCEtothecontrary(see4.1.2ofIEC62366:2007).
【中国标准分类号】:C37
【国际标准分类号】:11_040_01
【页数】:28P.;A4
【正文语种】:英语
【原文标准名称】:医用电气设备.基本安全性和基本性能的一般要求.并列标准.可用性
【标准号】:BSEN60601-1-6-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-05-31
【实施或试行日期】:2010-05-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Accidentprevention;Anaesthesiology;Classesofprotection;Classification;Colourcodes;Definitions;Design;Dimensions;Earthconductors;Earthing;Electriccontactprotection;Electricenclosures;Electricmains;Electricpowersystems;Electricshocks;Electricalaccidents;Electricalengineering;Electricalmedicalequipment;Electricalprotectionequipment;Electricalsafety;Electrically-operateddevices;Electromagneticcompatibility;Electromedicine;Electrostatics;EMC;Enclosures;Environmentalconditions;Equipmentsafety;Explosionprotection;Firesafety;Fitnessforpurpose;Graphicsymbols;Hazards;Inspection;Instructionsforuse;Insulatingenclosures;Insulations;Lists;Marking;Measurement;Measuringtechniques;Mechanicalsafety;Medicalequipment;Medicalradiology;Medicalsciences;Medicaltechnology;Occupationalsafety;Operationalinstructions;Protectionagainstelectricshocks;Protectioncoverings;Qualificationtests;Radiationprotection;Riskanalysis;Safety;Safetydevices;Safetyengineering;Safetyregulations;Safetyrequirements;Specification(approval);Strengthofmaterials;Surveys;Symbols;Testatmospheres;Testing;Testingconditions;Transformers
【摘要】:ThisInternationalStandardspecifiesaPROCESSforaMANUFACTURERtoanalyse,specify,design,VERIFYandVALIDATEUSABILITY,asitrelatestoBASICSAFETYandESSENTIALPERFORMANCEofMEDICALELECTRICALEQUIPMENT,hereafterreferredtoasMEEQUIPMENT.ThisUSABILITYENGINEERINGPROCESSassessesandmitigatesRISKScausedbyUSABILITYproblemsassociatedwithCORRECTUSEandUSEERRORS,i.e.,NORMALUSE.ItcanbeusedtoidentifybutdoesnotassessormitigateRISKSassociatedwithABNORMALUSE.IftheUSABILITYENGINEERINGPROCESSdetailedinthiscollateralstandardhasbeencompliedwithandtheacceptancecriteriadocumentedintheUSABILITYVALIDATIONplanhavebeenmet(see5.9ofIEC62366:2007),thentheRESIDUALRISKS,asdefinedinISO14971,associatedwithUSABILITYofMEEQUIPMENTarepresumedtobeacceptable,unlessthereisOBJECTIVEEVIDENCEtothecontrary(see4.1.2ofIEC62366:2007).
【中国标准分类号】:C37
【国际标准分类号】:11_040_01
【页数】:28P.;A4
【正文语种】:英语
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