【英文标准名称】:Medicalelectricalequipment-Part2-12:Particularrequirementsforbasicsafetyandessentialperformanceofcriticalcareventilators
【原文标准名称】:医疗电气设备.第2-12部分:急救护理呼吸机的基本安全性和本质性能的详细要求
【标准号】:ISO80601-2-12-2011
【标准状态】:现行
【国别】:国际
【发布日期】:2011-04-15
【实施或试行日期】:
【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】:事故预防;调节;送风;报警;α辐射线;人工呼吸;组装;袋;β辐射;生物适应性;呼吸;呼吸装置;呼吸设备;充电;夹件;等级;清洁处理;兼容性;校正(误差);组件;连接;恒电流;控制仪器;转角;封盖物;排除污染;缺陷;定义(术语);设计;介电强度;放电;消毒;长距通信;接地导线;接地;接地线端子;边;电力系统;电击;电气事故;电气工程;医用电气设备;电气安全性;电磁学;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;设备安全性;故障;过滤器;防火;火灾危险;柔性管;γ辐射;搬运;热传导;湿润剂;液压装置;红外线辐射;输入电流;检验;使用说明书;仪器;强化护理设备;强化护理病房;中断;钻模;激光辐射;布置;泄漏量;清晰度;极限;液体;光辐射;肺通气机;标志;质量(物质);测量仪器;机械安全性;力学;医用呼吸器;医疗设备;医学科学;医疗技术学;微波炉辐射;潮气;中子射线;噪声;护理;职业安全性;操作;引出端;溢水口;氧;供氧;包装件;纸;装置部件;患者辅助电流;气动力学;电位均衡;功率消耗;动力传动系统;精密度;压力;压力释放;压力容器;保护(装置);防电击;保护覆盖层;保护装置;辐射防护;电阻器;呼吸作用;呼吸器;安全性;安全性工程;安全性要求;分离;信号;声能;规范(验收);稳定性;灭菌;材料强度;应力;物质;表面;系统接地;温度;拉力;试验;试验条件;超声波学;紫外线辐射;使用;振动;能见度;体积;警告;工作数据;工作场所安全性;X射线
【英文主题词】:Accidentprevention;Adjustments;Airsupply;Alarm;Alpharadiation;Artificialrespiration;Assembling;Bags;Betaradiation;Biocompatibility;Breathing;Breathingapparatus;Breathingequipment;Chargings;Clamps;Classes;Cleaning;Compatibility;Compensation(errors);Components;Connections;Continuouscurrent;Controlinstruments;Corners;Covers;Decontaminations;Defects;Definitions;Design;Dielectricstrength;Discharge;Disinfections;Distanttransmission;Earthconductors;Earthing;Earthingconductorterminations;Edge;Electricpowersystems;Electricshock;Electricalaccidents;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromagnetism;Electromedicine;Electrostatics;EMC;Enclosures;Energy;Environmentalconditions;Environmentaltesting;Equipment;Equipmentsafety;Failure;Filters;Fireprevention;Firerisks;Flexiblepipes;Gamma-radiation;Handling;Heatexchange;Humectants;Hydraulics;Infraredradiation;Inputcurrent;Inspection;Instructionsforuse;Instruments;Intensivecareequipment;Intensive-careward;Interruptions;Jigs;Laserradiation;Layout;Leakage;Legibility;Limitations;Liquids;Luminousradiation;Lungventilators;Marking;Mass;Measuringinstruments;Mechanicalsafety;Mechanics;Medicalbreathingapparatus;Medicalequipment;Medicalsciences;Medicaltechnology;Microwaveradiation;Moisture;Neutronradiation;Noise;Nursing;Occupationalsafety;Operation;Outlets;Overflows;Oxygen;Oxygensupply;Packages;Paper;Partofadevice;Patientauxiliarycurrent;Pneumatics;Potentialequalization;Powerconsumption;Powertransmissionsystems;Precision;Pressure;Pressurereleases;Pressurevessels;Protection;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Radiationprotection;Resistors;Respiration;Respirators;Safety;Safetyengineering;Safetyrequirements;Separation;Signals;Soundenergy;Specification(approval);Stability;Sterilization(hygiene);Strengthofmaterials;Stress;Substances;Surfaces;Systemearthing;Temperature;Tensileforce;Testing;Testingconditions;Ultrasonics;Ultravioletradiation;Use;Vibrations;Visibility;Volume;Warnings;Workingdata;Workplacesafety;X-rays
【摘要】:Subclause1.1ofIEC60601-1:2005,Clause1isreplacedby:ThisInternationalStandardappliestotheBASICSAFETYandESSENTIALPERFORMANCEofaVENTILATORincombinationwithitsACCESSORIES,hereafterreferredtoasMEEQUIPMENT:?intendedtobeattendedbyaprofessionalOPERATORforthosePATIENTSwhoaredependentonmechanicalventilation;andNOTE1SuchVENTILATORSareconsideredaLIFE-SUPPORTINGMEEQUIPMENTORMESYSTEM.?intendedforuseincriticalcareenvironmentsinaprofessionalhealthcarefacilityorintendedforuseintransportwithinaprofessionalhealthcarefacility.NOTE2AcriticalcareVENTILATORintendedforuseintransportwithinaprofessionalhealthcarefacilityisnotconsideredanemergencyandtransportventilator.ThisInternationalStandardisalsoapplicabletothoseACCESSORIESintendedbytheirMANUFACTURERtobeconnectedtoaBREATHINGSYSTEM,ortoaVENTILATOR,wherethecharacteristicsofthoseACCESSORIEScanaffecttheBASICSAFETYorESSENTIALPERFORMANCEoftheVENTILATOR.ThisInternationalStandardisnotapplicabletoMEEQUIPMENToranMESYSTEMoperatinginventilationmodesintendedforpatientswhoarenotdependentonmechanicalventilation.NOTE3AcriticalcareVENTILATOR,whenoperatinginsuchamode,isnotconsideredLIFE-SUPPORTINGMEEQUIPMENTORMESYSTEM.IfaclauseorsubclauseisspecificallyintendedtobeapplicabletoMEEQUIPMENTonly,ortoMESYSTEMSonly,thetitleandcontentofthatclauseorsubclausewillsayso.Ifthatisnotthecase,theclauseorsubclauseappliesbothtoMEEQUIPMENTandtoMESYSTEMS,asrelevant.HAZARDSinherentintheintendedphysiologicalfunctionofMEEQUIPMENTorMESYSTEMSwithinthescopeofthisstandardarenotcoveredbyspecificrequirementsinthisstandardexceptinIEC60601-1:2005,7.2.13and8.4.1.NOTE4AdditionalinformationcanbefoundinIEC60601-1:2005,4.2.ThisInternationalStandardisnotapplicabletocontinuouspositiveairwaypressure(CPAP)MEEQUIPMENT,sleepapnoeatherapyMEEQUIPMENT,HOMEHEALTHCAREENVIRONMENTVENTILATORS,ventilatorysupportMEEQUIPMENT,emergencyandtransportventilators,anaestheticventilators,high-frequencyjetventilators(HFJVs)andhigh-frequencyoscillatoryventilators(HFOVs).[26]ThisInternationalStandarddoesnotspecifytherequirementsforMEEQUIPMENTthatisintendedsolelytoaugmenttheventilationofspontaneouslybreathingPATIENTSwithinaprofessionalhealthcarefacility.ThisInternationalStandarddoesnotspecifytherequirementsforVENTILATORSorACCESSORIESintendedforanaestheticapplicationswhicharegiveninISO80601-2-13.ThisInternationalStandarddoesnotspecifytherequirementsforVENTILATORSorACCESSORIESintendedforhomecareventilatorsforventilator-dependentPATIENTSwhicharegiveninISO10651-21).ThisInternationalStandarddoesnotspecifytherequirementsforVENTILATORSorACCESSORIESintendedforemergencyandtransportwhicharegiveninISO10651-32).ThisInternationalStandarddoesnotspecifytherequirementsforVENTILATORSorACCESSORIESintendedforhome-careventilatorysupportdeviceswhicharegiveninISO10651-63).
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:88P.;A4
【正文语种】:英语