IEC 62366-2007 医疗设备.医疗设备易用性工程的应用

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【英文标准名称】:Medicaldevices-Applicationofusabilityengineeringtomedicaldevices
【原文标准名称】:医疗设备.医疗设备易用性工程的应用
【标准号】:IEC62366-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-10
【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/SC62A
【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);训练;使用;证实
【英文主题词】:Accompanyingforms;Applications;Definitions;Design;Electricalengineering;Enterprises;Ergonomics;Fieldofapplications;Fitnessforpurpose;Handlings;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Presentations;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】:C37
【国际标准分类号】:11_040_01
【页数】:209P;A4
【正文语种】:英语