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【英文标准名称】:Lungventilatorsformedicaluse-Particularrequirementsforbasicsafetyandessentialperformance-Part2:Homecareventilatorsforventilator-dependentpatients
【原文标准名称】:医用肺通气机.基本安全和性能的特殊要求.第2部分:通气机依赖型病人用家庭护理通气机
【标准号】:ISO10651-2-2004
【标准状态】:现行
【国别】:国际
【发布日期】:2004-07
【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】:分类;电气工程;电气安全;电气设备;肺部感染;试验;检验;设备安全;环境条件;保护(装置);规范(验收);安全;定义;作标记;护理;安全工程;安全要求;设计;规范;家用记录仪;设备;家用;医学科学;防电击;医疗产品;呼吸器;医疗设备;应急设备;肺通气机;呼吸;辐射防护;呼吸设备;使用说明;通风机;肺脏;救护服务;救护工作;呼吸装置;强化护理设备;医用电气设备;医疗技术学;医院;工作数据;呼吸作用
【英文主题词】:Alarm;Alpharadiation;Ambulanceservices;Assembling;Bags;Betaradiation;Biocompatibility;Bodies;Breathing;Breathingapparatus;Breathingequipment;Changing;Clamps;Classification;Cleaning;Compatibility;Conditions;Connections;Continuouscurrent;Controlinstruments;Corners;Covers;Defects;Definitions;Design;Dielectricstrength;Discharge;Disinfections;Earthconductors;Earthingconductorterminations;Edge;Electricpowersystems;Electricalengineering;Electricalequipment;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electrostatics;EMC;Emergencyequipment;Enclosures;Energy;Energysupplysystems(buildings);Environmentalconditions;Environmentaltesting;Equipment;Equipmentsafety;Failure;Fireprevention;Firerisks;Flexiblepipes;Flows;Gamma-radiation;Handling;Heatexchangers;Homehealthcareenvironment;Homeuse;Homes;Hospitals;Householduse;Humectants;Infraredradiation;Inputcurrent;Inspection;Instructionsforuse;Intensivecareequipment;Laserbeams;Layout;Limitations;Liquids;Luminousradiation;Lungventilators;Lungs;Marking;Mass;Measurement;Measuringinstruments;Mechanics;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Microwaveradiation;Moisture;Neutronradiation;Noise;Nursing;Outlets;Overflows;Oxygen;Paper;Patientauxiliarycurrent;Pneumatics;Potentialequalization;Powerconsumption;Powertransmissionsystems;Precision;Pressure;Pressurevessels;Protection;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Pulmonaryaffection;Radiationprotection;Rescueandambulanceservices;Respiration;Respirators;Safety;Safetyengineering;Safetyrequirements;Separation;Soundenergy;Specification;Specification(approval);Stability;Sterilization(hygiene);Strengthofmaterials;Substances;Surfaces;Systemearthing;Temperature;Testing;Ultrasonics;Ultravioletradiation;Use;Ventilators;Vibrations;Workingdata;X-rays
【摘要】:IEC60601-1:1988,Clause1applies,exceptasfollows.Amendment:ThispartofISO10651specifiesrequirementsforlungventilatorsintendedforhomeapplicationsforthosepatientswhoaredependentonventilatorysupport.Suchventilatorsareconsideredlife-supportingequipment,arefrequentlyusedinlocationswheredrivingpowerisnotreliable,andareoftensupervisedbynon-healthcarepersonnelwithdifferentlevelsoftraining.ThispartofISO10651isnotapplicabletocuirassand"iron-lung"ventilators.ThispartofISO10651isnotapplicabletoventilatorsintendedonlytoaugmenttheventilationofspontaneouslybreathingpatients.TherequirementsofthispartofISO10651whichreplaceormodifytherequirementsofIEC60601-1:1988anditsAmendments1(1991)and2(1995)areintendedtotakeprecedenceoverthecorrespondinggeneralrequirements.
【中国标准分类号】:C45
【国际标准分类号】:11_040_10
【页数】:31P;A4
【正文语种】:英语