【英文标准名称】:Medicalelectricalequipment.Particularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipment
【原文标准名称】:医用电气设备.对脉搏血氧计设备基本安全和基本性能的特殊要求
【标准号】:BSENISO80601-2-61-2011
【标准状态】:现行
【国别】:英国
【发布日期】:2011-08-31
【实施或试行日期】:2011-08-31
【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】:
【英文主题词】:Alarm;Alpharadiation;Anaestheticequipment;Assembling;Betaradiation;Biocompatibility;Bloodcounts;Bodies;Breathingequipment;Chargings;Chemicalanalysisandtesting;Clamps;Cleaning;Compatibility;Components;Connections;Continuouscurrent;Corners;Covers;Defects;Definitions;Determinations;Dielectricstrength;Discharge;Disinfections;Earthconductors;Earthingconductorterminations;Edge;Electricpowersystems;Electrical;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Electrostatics;EMC;Enclosures;Energy;Environmentalconditions;Environmentaltesting;Equipmentsafety;Fireprevention;Gamma-radiation;Haemoglobin;Haemoglobincontent;Hydraulics;Infraredradiation;Inputcurrent;Interruptions;Laserbeams;Layout;Limitations;Liquids;Luminousradiation;Mass;Measuringinstruments;Mechanics;Medicaldevices;Medicalequipment;Medicalsciences;Medicaltechnology;Moisture;Neutronradiation;Noise;Outlets;Overflows;Oximeters;Oximetry;Oxygensaturation;Paper;Patientauxiliarycurrent;Performancerequirements;Pneumatics;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Protectivemeasures;Pulse;Pulseoximeters;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Saturation;Separation;Signals;Soundenergy;Specification(approval);Stability;Sterilization(hygiene);Strengthofmaterials;Stress;Surfaces;Systemearthing;Temperature;Testing;Ultrasonics;Ultravioletradiation;Use;Vibrations;Workingdata;X-rays
【摘要】:Subclause1.1ofThegeneralstandardisreplacedby:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofPULSEOXIMETEREQUIPMENTintendedforuseonhumans,hereafterreferredtoasMEEQUIPMENT.ThisincludesanypartnecessaryforNORMALUSE,includingthePULSEOXIMETERMONITOR,PULSEOXIMETERPROBE,andPROBECABLEEXTENDER.TheserequirementsalsoapplytoPULSEOXIMETEREQUIPMENT,includingPULSEOXIMETERMONITORS,PULSEOXIMETERPROBESandPROBECABLEEXTENDERS,whichhavebeenREPROCESSED.TheintendeduseofPULSEOXIMETEREQUIPMENTincludes,butisnotlimitedto,theestimationofarterialoxygenhaemoglobinsaturationandpulserateofPATIENTSinprofessionalhealthcareinstitutionsaswellasPATIENTSintheHOMEHEALTHCAREENVIRONMENT.ThisInternationalStandardisnotapplicabletoPULSEOXIMETEREQUIPMENTintendedforuseinlaboratoryresearchapplicationsnortooximetersthatrequireabloodsamplefromthePATIENT.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptin201.11andin7.2.13and8.4.1ofthegeneralstandard.NOTESeealso4.2ofthegeneralstandard.ThisstandardcanalsobeappliedtoPULSEOXIMETEREQUIPMENTandtheirACCESSORIESusedforcompensationoralleviationofdisease,injuryordisability.ThisInternationalStandardisnotapplicabletoPULSEOXIMETEREQUIPMENTintendedsolelyforfoetaluse.ThisInternationalStandardisnotapplicabletoremoteorslave(secondary)devicesthatdisplaySpO2valuesthatarelocatedoutsideofthePATIENTENVIRONMENT.
【中国标准分类号】:C38
【国际标准分类号】:11_040_55
【页数】:98P.;A4
【正文语种】:英语