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【英文标准名称】:Medicalelectricalequipment-Particularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitors
【原文标准名称】:医疗电气设备.呼吸气监测器的基本安全和主要性能的特殊要求
【标准号】:ISO21647-2004
【标准状态】:现行
【国别】:国际
【发布日期】:2004-11
【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】:气体;安全工程;分类系统;医疗技术学;防电击;电磁兼容性;电力系统;呼吸气;试验;分类;定义;医疗设备;麻醉学;呼吸设备;救护服务;作标记;安全要求;监视装置;控制仪器;含氧量;麻醉设备;混合气体;监督(认可);使用说明;医用气体;医院设备;氧;供氧设备;呼吸装置;特点;规范(验收);医用呼吸器;二氧化碳;电气安全;文字书写;氧气浓度;事故预防;安全;测量仪器
【英文主题词】:Accidentprevention;Adjusters;Alarm;Alpharadiation;Anaesthesiology;Anaestheticequipment;Analyzers;Applications;Assembling;Betaradiation;Biocompatibility;Bodies;Breathingapparatus;Breathingequipment;Capnometers;Carbondioxide;Chargings;Clamps;Classification;Classificationsystems;Cleaning;Closures;Combustible;Compatibility;Components;Concentration;Condensation;Conduits;Conglomerates;Connections;Contact;Continuouscurrent;Control;Controlinstruments;Corners;Covers;Defects;Definitions;Design;Detailspecification;Determinations;Dielectricstrength;Discharge;Disinfections;Drift;Earthconductors;Earthingconductorterminations;Edge;Electricpowersystems;Electricshock;Electrical;Electricalappliances;Electricalengineering;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electromedicine;Electrostatics;EMC;Enclosures;Energy;Environmentalcondition;Environmentalconditions;Environmentaltesting;Equipmentsafety;Exhaustgases;Explosionprotection;Features;Fireprevention;Firerisks;Firesafety;Gamma-radiation;Gasanalysis;Gasmeasuringinstruments;Gasmixtures;Gases;Handling;Hospitalequipment;Hydraulics;Ignition;Impurities;Indications;Infraredradiation;Inhalation;Inputcurrent;Inscription;Instructionsforuse;Instruments;Interferences;Interruptions;Laserbeams;Layout;Leakage;Letterings;Limitations;Liquids;Luminousradiation;Marking;Mass;Materials;Measurement;Measuringaccuracy;Measuringinstruments;Medicalbreathingapparatus;Medicaldevices;Medicalequipment;Medicalgases;Medicaltechnology;Microwaveradiation;Moisture;Monitoringdevice;Neutronradiation;Noise;Operation;Outlets;Overflows;Oxygen;Oxygenbreathingapparatus;Oxygenconcentration;Oxygencontent;Paper;Partialpressures;Patientauxiliarycurrent;Patients;People;Pneumatics;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protection;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Radiation;Radiationprotection;Rescueandambulanceservices;Respiration;Respiratorysystem;Respiredgases;Safety;Safetyengineering;Safetymeasures;Safetyrequirements;Samples;Sensors;Separation;Sequenceofoperations;Signals;Sound;Soundenergy;Soundpressurelevel;Spark;Specification(approval);Stability;Steam;Sterilization(hygiene);Strengthofmaterials;Stress;Surfaces;Surveillance(approval);Systemearthing;Temperature;Testing;Ultrasonics;Ultravioletradiation;Use;Vapours;Vibrations;Workingdata;X-rays
【摘要】:IEC60601-1:1998,Clause1,applies,exceptasfollows.Amendment(addattheendof1.1):ThisInternationalStandardspecifiesparticularrequirementsforthebasicsafetyandessentialperformanceofrespiratorygasmonitors(RGM)(asdefinedin3.15)intendedforcontinuousoperationforusewithhumans.ThisInternationalStandardspecifiesrequirementsforaa)anaestheticgasmonitoring,bb)carbondioxidemonitoring,cc)oxygenmonitoring.ThisInternationalStandardisnotapplicabletomonitorsintendedforusewithflammableanaestheticagents.TherequirementsofthisInternationalStandardwhichreplaceormodifytherequirementsofIEC60601-1:1988anditsAmendments1(1991)and2(1995)areintendedtotakeprecedenceoverthecorrespondinggeneralrequirements.EnvironmentalaspectsareaddressedinAnnexCC.NOTEAdditionalaspectsofenvironmentalimpactareaddressedinISO14971.
【中国标准分类号】:C39
【国际标准分类号】:11_040_10
【页数】:40P;A4
【正文语种】:英语