【英文标准名称】:Medicalelectricalequipment-Part2-61:Particularrequirementsforbasicsafetyandessentialperformanceofpulseoximeterequipment
【原文标准名称】:医疗电气设备.第2-61部分:脉动光电血氧计设备的基础安全性和基本性能详细要求
【标准号】:ISO80601-2-61-2011
【标准状态】:现行
【国别】:国际
【发布日期】:2011-04-01
【实施或试行日期】:2011-04-01
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC121
【标准类型】:()
【标准水平】:()
【中文主题词】:警报;α辐射;麻醉设备;组装;β辐射;生物适应性;血细胞计数;壳体;呼吸设备;充电;化学分析和测试;夹具;清洁处理;兼容性;元部件;连接;恒电流;转角;封盖物;缺陷;定义(术语);测定;介电强度;放电;消毒;接地导线;接地线端子;边;电力系统;电气的;电气工程;医用电气设备;电气安全性;电磁兼容性;电医学;静电学;电磁兼容性(EMC);外壳;能量;环境条件;环境测试;设备安全性;防火;γ辐射;血红蛋白;血色素含量;液压装置;红外线辐射;输入电流;中断;激光束;布置;极限;液体;发光辐射;质量(物质);测量仪器;力学;医疗器材;医学科学;医疗技术学;潮气;中子射线;噪声;引出端;溢水口;光电血氧计;血氧定量法;氧饱和;纸;患者辅助电流;性能要求;气动力学;电位均衡;功率消耗;精密度;压力;压力容器;防电击;保护覆盖层;保护装置;保护措施;脉冲;脉动血氧计;辐射防护;安全性;安全性工程;安全性要求;饱和;分离;信号;声能;规范(验收);稳定性;灭菌;材料强度;应力;表面;系统接地;温度;测试;超声波学;紫外线辐射;使用;振动;工作数据;X射线
【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;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)devicesthatdisplaySpOvaluesthatarelocatedoutsideofthePATIENTENVIRONMENT.
【中国标准分类号】:C39
【国际标准分类号】:11_040_10
【页数】:92P.;A4
【正文语种】:英语