BS EN 62366-2008 医疗设备.医疗设备可用性工程的应用
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【英文标准名称】:Medicaldevices-Applicationofusabilityengineeringtomedicaldevices
【原文标准名称】:医疗设备.医疗设备可用性工程的应用
【标准号】:BSEN62366-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2008-04-30
【实施或试行日期】:2008-04-30
【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】:随附表格;应用;定义;设计;电气工程;企业;人类工效学;应用领域;适用性;操纵;医疗设备;医疗产品;医学科学;医疗技术学;生产;安全;规范(验收);培训;使用;有校性
【英文主题词】:Accompanyingforms;Applications;Definition;Definitions;Design;Electricalengineering;Enterprises;Ergonomics;Fieldofapplications;Fitnessforpurpose;Handlings;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Production;Safety;Specification(approval);Training;Usage;Use;Validation
【摘要】:ThisInternationalStandardspecifiesaPROCESSforaMANUFACTURERtoanalyse,specify,design,VERIFYandVALIDATEUSABILITY,asitrelatestoSAFETYofaMEDICALDEVICE.ThisUSABILITYENGINEERINGPROCESSassessesandmitigatesRISKScausedbyUSABILITYproblemsassociatedwithCORRECTUSEandUSEERRORS,i.e.NORMALUSE.ItcanbeusedtoidentifybutdoesnotassessormitigateRISKSassociatedwithABNORMALUSE.NOTEForthepurposesofthisstandard,USABILITY(see3.17)islimitedtocharacteristicsoftheUSERINTERFACE.IftheUSABILITYENGINEERINGPROCESSdetailedinthisInternationalStandardhasbeencompliedwithandtheacceptancecriteriadocumentedintheUSABILITYVALIDATIONplanhavebeenmet(see5.9),thentheRESIDUALRISKS,asdefinedinISO14971,associatedwithUSABILITYofaMEDICALDEVICEarepresumedtobeacceptable,unlessthereisOBJECTIVEEVIDENCEtothecontrary(see4.1.2).ThisInternationalStandarddoesnotapplytoclinicaldecision-makingrelatingtotheuseofaMEDICALDEVICE.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01
【页数】:104P.;A4
【正文语种】:英语
【原文标准名称】:医疗设备.医疗设备可用性工程的应用
【标准号】:BSEN62366-2008
【标准状态】:现行
【国别】:英国
【发布日期】:2008-04-30
【实施或试行日期】:2008-04-30
【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】:随附表格;应用;定义;设计;电气工程;企业;人类工效学;应用领域;适用性;操纵;医疗设备;医疗产品;医学科学;医疗技术学;生产;安全;规范(验收);培训;使用;有校性
【英文主题词】:Accompanyingforms;Applications;Definition;Definitions;Design;Electricalengineering;Enterprises;Ergonomics;Fieldofapplications;Fitnessforpurpose;Handlings;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Production;Safety;Specification(approval);Training;Usage;Use;Validation
【摘要】:ThisInternationalStandardspecifiesaPROCESSforaMANUFACTURERtoanalyse,specify,design,VERIFYandVALIDATEUSABILITY,asitrelatestoSAFETYofaMEDICALDEVICE.ThisUSABILITYENGINEERINGPROCESSassessesandmitigatesRISKScausedbyUSABILITYproblemsassociatedwithCORRECTUSEandUSEERRORS,i.e.NORMALUSE.ItcanbeusedtoidentifybutdoesnotassessormitigateRISKSassociatedwithABNORMALUSE.NOTEForthepurposesofthisstandard,USABILITY(see3.17)islimitedtocharacteristicsoftheUSERINTERFACE.IftheUSABILITYENGINEERINGPROCESSdetailedinthisInternationalStandardhasbeencompliedwithandtheacceptancecriteriadocumentedintheUSABILITYVALIDATIONplanhavebeenmet(see5.9),thentheRESIDUALRISKS,asdefinedinISO14971,associatedwithUSABILITYofaMEDICALDEVICEarepresumedtobeacceptable,unlessthereisOBJECTIVEEVIDENCEtothecontrary(see4.1.2).ThisInternationalStandarddoesnotapplytoclinicaldecision-makingrelatingtotheuseofaMEDICALDEVICE.
【中国标准分类号】:C30
【国际标准分类号】:11_040_01
【页数】:104P.;A4
【正文语种】:英语
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