BS EN 61010-2-101-2002 测量、控制和实验室用电气设备的安全要求.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-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.实验室诊断(IVD)医疗设备的特殊要求
【标准号】:BSEN61010-2-101-2002
【标准状态】:现行
【国别】:英国
【发布日期】:2002-12-09
【实施或试行日期】:2002-12-09
【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】:实验室器皿;安全;定义;安全要求;规范(验收);在实验室条件下;电气器具;诊断设备;测量仪器;实验室条件下诊断;控制设备;试验;医疗设备;实验室医学;实验室器具;电气工程
【英文主题词】:Controlequipment;Definition;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;oracongenitalabnormality;thedeterminationofsafetyandcompatibilitywithpotentialrecipients;themonitoringoftherapeuticmeasures.Self-testIVDmedicalequipmentisintendedbythemanufacturerforusebylaypersonsinahomeenvironment.NOTEIfallorpartoftheequipmentfallswithinthescopeofoneormoreotherpart2standardsofIEC61010aswellaswithinthescopeofthisstandard,itwillalsoneedtomeettherequirementsofthoseotherpart2standards.
【中国标准分类号】:N20
【国际标准分类号】:11_100_10
【页数】:26P;A4
【正文语种】:英语