IEC 61010-2-101-2002 测量、控制和实验室用电气设备的安全要求.第2-101部分:实验室诊断(IVD)医疗设备的特殊要求

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【英文标准名称】:Safetyrequirementsforelectricalequipmentformeasurement,controlandlaboratoryuse-Part2-101:Particularrequirementsforinvitrodiagnostic(IVD)medicalequipment
【原文标准名称】:测量、控制和实验室用电气设备的安全要求.第2-101部分:实验室诊断(IVD)医疗设备的特殊要求
【标准号】:IEC61010-2-101-2002
【标准状态】:现行
【国别】:国际
【发布日期】:2002-01
【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/TC66
【标准类型】:()
【标准水平】:()
【中文主题词】:在实验室条件下;安全;诊断设备;测量仪器;安全要求;实验室器皿;规范(验收);试验;电气器具;实验室条件下诊断;医疗设备;实验室医学;实验室器具;定义;控制设备;电气工程
【英文主题词】:Controlequipment;Definitions;Diagnosticequipment;Electricappliances;Electricalengineering;Invitro;In-vitrodiagnostic;Laboratoryapparatus;Laboratorymedicine;Laboratoryware;Measuringinstruments;Medicalequipment;Safety;Safetyrequirements;Specification(approval);Testing
【摘要】:Replacement:Thispart2appliestoequipmentintendedforinvitrodiagnostic(IVD)medicalpurposes,includingself-testIVDmedicalpurposes.IVDmedicalequipment,whetherusedaloneorincombination,isintendedbythemanufacturertobeusedinvitrofortheexaminationofspecimens,includingbloodandtissuesamples,derivedfromthehumanbody,solelyorprincipallyforthepurposeofprovidinginformationconcerningoneormoreofthefollowing:·aphysiologicalorpathologicalstate;or·acongenitalabnormality;·thedeterminationofsafetyandcompatibilitywithpotentialrecipients;·themonitoringoftherapeuticmeasures.Self-testIVDmedicalequipmentisintendedbythemanufacturerforusebylaypersonsinahomeenvironment.NOTEIfallorpartoftheequipmentfallswithinthescopeofoneormoreotherpart2standardsofIEC61010aswellaswithinthescopeofthisstandard,itwillalsoneedtomeettherequirementsofthoseotherpart2standards.2EquipmentexcludedfromscopeAddition:Addthefollowingsecondparagraph:ProductsforgenerallaboratoryusearenotIVDmedicaldevicesunlesssuchproducts,inviewoftheircharacteristics,arespecificallyintendedbytheirmanufacturertobeusedforinvitrodiagnosticexamination.
【中国标准分类号】:N20
【国际标准分类号】:11_100_10
【页数】:43P;A4
【正文语种】:英语