【英文标准名称】:Lungventilatorsformedicaluse-Particularrequirementsforbasicsafetyandessentialperformance-Part2:Homecareventilatorsforventilator-dependentpatients(ISO10651-2:2004);GermanversionENISO10651-2:2009
【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:通气机依赖型患者用家庭保健通气机(ISO10651-2-2004);德文版ENISO10651-2-2009
【标准号】:DINENISO10651-2-2011
【标准状态】:现行
【国别】:德国
【发布日期】:2011-06
【实施或试行日期】:2009-08-01
【发布单位】:德国标准化学会(DE-DIN)
【起草单位】:
【标准类型】:()
【标准水平】:()
【中文主题词】:
【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】:IEC60601-1:1998,Clause1applies,exceptasfollows.Amendment:ThispartofISO10651specifiesrequirementsforlungventilatorsintendedforhomecareapplicationsforthosepatientswhoaredependentonventilatorysupport.Suchventilatorsareconsideredlife-supportingequipment.Theseventilatorsarefrequentlyusedinlocationswheredrivingpowerisnotreliableandareoftensupervisedbynon-healthcarepersonnelwithdifferentlevelsoftraining.
【中国标准分类号】:
【国际标准分类号】:11_040_10
【页数】:46P.;A4
【正文语种】:英语