DIN EN ISO 10651-2-2009 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);德文版本ENISO10651-2-2009
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【英文标准名称】:Lungventilatorsformedicaluse-Particularrequirementsforbasicsafetyandessentialperformance-Part2:Homecareventilatorsforventilator-dependentpatients(ISO10651-2:2004);EnglishversionofDINENISO10651-2:2009-08
【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);德文版本ENISO10651-2-2009
【标准号】:DINENISO10651-2-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-08
【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】:警报;α辐射;α辐射线;救护工作;组装;袋;β辐射;生物适应性;壳体;呼吸;呼吸装置;呼吸设备;变更;夹具;分类;清洁处理;兼容性;条件;连接件;直流;控制仪器;转角;封盖物;缺陷与故障;定义;设计;介电强度;放电;卸货;消毒;接地导线;接地线端子;边;电力系统;电气工程;电气设备;医用电气设备;电气安全;电磁兼容性;静电学;EMC;应急设备;外壳;能量;供能系统(建筑物);环境条件;环境试验;设备;设备安全;故障;失效;防火;火灾危险;柔性管;流动;γ辐射;操作;热交换器;家用保健环境;家用;家;医院;家庭用;湿润剂;红外线辐射;输入电流;检验;使用说明书;强化护理设备;激光束;布置;极限;液体;光辐射;肺通气机;肺脏;处理;质量(物质);测量;测量仪器;力学;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;微波炉辐射;潮气;中子射线;噪声;护理;出口;溢水口;氧;纸;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;压力容器;保护(装置);防电击;保护覆盖层;保护装置;肺部影响;辐射防护;救护服务;呼吸作用;呼吸器;安全;安全工程;安全要求;分离;声能;规范;规范(验收);稳定性;灭菌;材料强度;物质;表面;系统接地;温度;试验;超声波学;紫外线辐射;使用;通风机;振动;工作数据;X射线
【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】:C46
【国际标准分类号】:11_040_10
【页数】:46P.;A4
【正文语种】:英语
【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);德文版本ENISO10651-2-2009
【标准号】:DINENISO10651-2-2009
【标准状态】:作废
【国别】:德国
【发布日期】:2009-08
【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】:警报;α辐射;α辐射线;救护工作;组装;袋;β辐射;生物适应性;壳体;呼吸;呼吸装置;呼吸设备;变更;夹具;分类;清洁处理;兼容性;条件;连接件;直流;控制仪器;转角;封盖物;缺陷与故障;定义;设计;介电强度;放电;卸货;消毒;接地导线;接地线端子;边;电力系统;电气工程;电气设备;医用电气设备;电气安全;电磁兼容性;静电学;EMC;应急设备;外壳;能量;供能系统(建筑物);环境条件;环境试验;设备;设备安全;故障;失效;防火;火灾危险;柔性管;流动;γ辐射;操作;热交换器;家用保健环境;家用;家;医院;家庭用;湿润剂;红外线辐射;输入电流;检验;使用说明书;强化护理设备;激光束;布置;极限;液体;光辐射;肺通气机;肺脏;处理;质量(物质);测量;测量仪器;力学;医疗器械;医疗设备;医疗产品;医学科学;医疗技术学;微波炉辐射;潮气;中子射线;噪声;护理;出口;溢水口;氧;纸;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;压力容器;保护(装置);防电击;保护覆盖层;保护装置;肺部影响;辐射防护;救护服务;呼吸作用;呼吸器;安全;安全工程;安全要求;分离;声能;规范;规范(验收);稳定性;灭菌;材料强度;物质;表面;系统接地;温度;试验;超声波学;紫外线辐射;使用;通风机;振动;工作数据;X射线
【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】:C46
【国际标准分类号】:11_040_10
【页数】:46P.;A4
【正文语种】:英语
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