【英文标准名称】:Medicalelectricalequipment.Particularrequirementsforthebasicsafetyandessentialperformanceofautomatednon-invasivesphygmomanometers
【原文标准名称】:医疗电气设备.自动非入侵式血压测量计的基本安全和主要性能的特定要求
【标准号】:BSEN80601-2-30-2010
【标准状态】:现行
【国别】:英国
【发布日期】:2010-10-31
【实施或试行日期】:2010-10-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:IEC/TC55
【标准类型】:()
【标准水平】:()
【中文主题词】:
【英文主题词】:Automatic;Bloodpressure;Bloodpressuremeter;Controlinstruments;Cyclic;Definitions;Determinations;Efficiency;Electricappliances;Electricalengineering;Electricalsafety;Electromedicine;Measuringinstruments;Medicalequipment;Medicalsciences;Medicaltechnology;Protectionagainstelectricshocks;Safety;Safetyengineering;Safetyrequirements;Specification(approval);Sphygmography;Sphygmomanometers;Surveillance(approval);Testing
【摘要】:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofAUTOMATEDSPHYGMOMANOMETERS,hereafterreferredtoasMEEQUIPMENT,whichbymeansofaninflatableCUFF,areusedforintermittentindirectmeasurementoftheBLOODPRESSUREwithoutarterialpuncture.ThisstandardspecifiesrequirementsfortheBASICSAFETYandESSENTIALPERFORMANCEforthisMEEQUIPMENTanditsACCESSORIES,includingtherequirementsfortheaccuracyofaDETERMINATION.Thisstandardcoverselectrically-poweredintermittent,indirectmeasurementoftheBLOODPRESSUREwithoutarterialpuncture,MEEQUIPMENTwithautomaticmethodsforestimatingBLOODPRESSURE,includingBLOODPRESSUREmonitorsfortheHOMEHEALTHCAREENVIRONMENT.RequirementsforindirectmeasurementoftheBLOODPRESSUREwithoutarterialpunctureMEEQUIPMENTwithanelectrically-poweredPRESSURETRANSDUCERand/ordisplaysusedinconjunctionwithastethoscopeorothermanualmethodsfordeterminingBLOODPRESSURE(NON-AUTOMATEDSPHYGMOMANOMETERS)arespecifiedindocumentISO81060-1.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin201.11and201.105.3.3,aswellas7.2.13and8.4.1ofIEC60601-1.
【中国标准分类号】:
【国际标准分类号】:11_040_55
【页数】:58P;A4
【正文语种】:英语