DIN EN ISO 8359-2009 医用氧气浓缩器.安全性要求(ISO8359-1996);德文版本ENISO8359-2009
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【英文标准名称】:Oxygenconcentratorsformedicaluse-Safetyrequirements(ISO8359:1996);EnglishversionofDINENISO8359:2009-08
【原文标准名称】:医用氧气浓缩器.安全性要求(ISO8359-1996);德文版本ENISO8359-2009
【标准号】:DINENISO8359-2009
【标准状态】:现行
【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】:事故预防;α辐射;组装;β辐射;生物适应性;壳体;呼吸装置;呼吸设备;充电;夹具;分类;清洁处理;色码;组件;浓缩器;连接件;直流;转角;封盖物;缺陷与故障;定义;介电强度;消毒;接地导线;接地线端子;边;电力系统;电击;电气安全;电磁兼容性;静电学;EMC;外壳;能量;环境条件;环境试验;设备安全;爆炸危险;防爆;故障;防火;消防;火灾危险;防火安全;γ辐射;煤气;格栅;高温防护;液压装置;指示;红外线辐射;内部的空气;输入电流;作标记;检验;使用说明书;仪器;中断;激光束;布置;液体;光辐射;处理;质量(物质);机械安全;医用呼吸器;医疗器械;医疗设备;医用气体;医学科学;医疗技术学;药用植物;微波炉辐射;潮气;噪声;职业安全;操作说明书;出口;溢水口;氧;供氧设备;氧浓度;纸;患者辅助电流;气动力学;电位均衡;功率消耗;精密度;压力;压力容器;保护(装置);危险防护;保护覆盖层;保护装置;辐射防护;安全;安全工程;安全要求;分离;声音;声能;规范;规范(验收);详细规范;稳定性;灭菌;材料强度;应力;供应;表面;系统接地;技术数据单;温度;试验组织;测试;热防护;超声波学;紫外线辐射;使用;振动;工作数据
【英文主题词】:Accidentprevention;Alpharadiation;Assembling;Betaradiation;Biocompatibility;Bodies;Breathingapparatus;Breathingequipment;Chargings;Clamps;Classification;Cleaning;Colourcodes;Components;Concentrators;Connections;Continuouscurrent;Corners;Covers;Defects;Definitions;Dielectricstrength;Disinfections;Earthconductors;Earthingconductorterminations;Edge;Electricpowersystems;Electricshock;Electricalsafety;Electromagneticcompatibility;Electrostatics;EMC;Enclosures;Energy;Environmentalconditions;Environmentaltesting;Equipmentsafety;Explosionhazard;Explosionprotection;Failure;Fireprevention;Fireprotection;Firerisks;Firesafety;Gamma-radiation;Gases;Grids;Heatprotection;Hydraulics;Indications;Infraredradiation;Inneratmosphere;Inputcurrent;Inscription;Inspection;Instructionsforuse;Instruments;Interruptions;Laserbeams;Layout;Liquids;Luminousradiation;Marking;Mass;Mechanicalsafety;Medicalbreathingapparatus;Medicaldevices;Medicalequipment;Medicalgases;Medicalsciences;Medicaltechnology;Medicinalplants;Microwaveradiation;Moisture;Noise;Occupationalsafety;Operationalinstructions;Outlets;Overflows;Oxygen;Oxygenbreathingapparatus;Oxygenconcentration;Paper;Patientauxiliarycurrent;Pneumatics;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protection;Protectionagainstdanger;Protectioncoverings;Protectivedevices;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Separation;Sound;Soundenergy;Specification;Specification(approval);Specifications;Stability;Sterilization(hygiene);Strengthofmaterials;Stress;Supply;Surfaces;Systemearthing;Technicaldatasheets;Temperature;Testset-ups;Testing;Thermalprotection;Ultrasonics;Ultravioletradiation;Use;Vibrations;Workingdata
【摘要】:NOTE1SeetherationaleinannexP.ISO8359isoneofaseriesofInternationalStandardsbasedonIEC601-1.InIEC601-1(the"GeneralStandard"),thistypeofInternationalStandardisreferredtoasa"ParticularStandard".Asstatedin1,3ofIEC601-1:1988,therequirementsofthisInternationalStandardtakeprecedenceoverthoseofIEC601-1.Thescopeandobjectgiveninclause1ofIEC601-1:1988apply,exceptthat1,1shallbereplacedbythefollowing:ThisInternationalStandardspecifiessafetyrequirementsforcontinuous-flowoxygenconcentrators,asdefinedin1.3.8(inthisInternationalStandard).ThisInternationalStandarddoesnotapplytooxygenconcentratorsintendedtosupplygastoseveralpatientsviaapipedmedicalgasinstallationortothoseintendedforuseinthepresenceofflammableanaestheticand/orcleaningagents.ThescopeofthisInternationalStandardisnotrestrictedtomembraneoxygenconcentratorsandpressureswingabsorbers(seeIntroduction),asalternativemethodsofconcentratingoxygenmaybecomeavailableanditisnotintendedthatthisInternationalStandardshouldrestrictfuturedevelopments.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:36P.;A4
【正文语种】:英语
【原文标准名称】:医用氧气浓缩器.安全性要求(ISO8359-1996);德文版本ENISO8359-2009
【标准号】:DINENISO8359-2009
【标准状态】:现行
【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】:事故预防;α辐射;组装;β辐射;生物适应性;壳体;呼吸装置;呼吸设备;充电;夹具;分类;清洁处理;色码;组件;浓缩器;连接件;直流;转角;封盖物;缺陷与故障;定义;介电强度;消毒;接地导线;接地线端子;边;电力系统;电击;电气安全;电磁兼容性;静电学;EMC;外壳;能量;环境条件;环境试验;设备安全;爆炸危险;防爆;故障;防火;消防;火灾危险;防火安全;γ辐射;煤气;格栅;高温防护;液压装置;指示;红外线辐射;内部的空气;输入电流;作标记;检验;使用说明书;仪器;中断;激光束;布置;液体;光辐射;处理;质量(物质);机械安全;医用呼吸器;医疗器械;医疗设备;医用气体;医学科学;医疗技术学;药用植物;微波炉辐射;潮气;噪声;职业安全;操作说明书;出口;溢水口;氧;供氧设备;氧浓度;纸;患者辅助电流;气动力学;电位均衡;功率消耗;精密度;压力;压力容器;保护(装置);危险防护;保护覆盖层;保护装置;辐射防护;安全;安全工程;安全要求;分离;声音;声能;规范;规范(验收);详细规范;稳定性;灭菌;材料强度;应力;供应;表面;系统接地;技术数据单;温度;试验组织;测试;热防护;超声波学;紫外线辐射;使用;振动;工作数据
【英文主题词】:Accidentprevention;Alpharadiation;Assembling;Betaradiation;Biocompatibility;Bodies;Breathingapparatus;Breathingequipment;Chargings;Clamps;Classification;Cleaning;Colourcodes;Components;Concentrators;Connections;Continuouscurrent;Corners;Covers;Defects;Definitions;Dielectricstrength;Disinfections;Earthconductors;Earthingconductorterminations;Edge;Electricpowersystems;Electricshock;Electricalsafety;Electromagneticcompatibility;Electrostatics;EMC;Enclosures;Energy;Environmentalconditions;Environmentaltesting;Equipmentsafety;Explosionhazard;Explosionprotection;Failure;Fireprevention;Fireprotection;Firerisks;Firesafety;Gamma-radiation;Gases;Grids;Heatprotection;Hydraulics;Indications;Infraredradiation;Inneratmosphere;Inputcurrent;Inscription;Inspection;Instructionsforuse;Instruments;Interruptions;Laserbeams;Layout;Liquids;Luminousradiation;Marking;Mass;Mechanicalsafety;Medicalbreathingapparatus;Medicaldevices;Medicalequipment;Medicalgases;Medicalsciences;Medicaltechnology;Medicinalplants;Microwaveradiation;Moisture;Noise;Occupationalsafety;Operationalinstructions;Outlets;Overflows;Oxygen;Oxygenbreathingapparatus;Oxygenconcentration;Paper;Patientauxiliarycurrent;Pneumatics;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protection;Protectionagainstdanger;Protectioncoverings;Protectivedevices;Radiationprotection;Safety;Safetyengineering;Safetyrequirements;Separation;Sound;Soundenergy;Specification;Specification(approval);Specifications;Stability;Sterilization(hygiene);Strengthofmaterials;Stress;Supply;Surfaces;Systemearthing;Technicaldatasheets;Temperature;Testset-ups;Testing;Thermalprotection;Ultrasonics;Ultravioletradiation;Use;Vibrations;Workingdata
【摘要】:NOTE1SeetherationaleinannexP.ISO8359isoneofaseriesofInternationalStandardsbasedonIEC601-1.InIEC601-1(the"GeneralStandard"),thistypeofInternationalStandardisreferredtoasa"ParticularStandard".Asstatedin1,3ofIEC601-1:1988,therequirementsofthisInternationalStandardtakeprecedenceoverthoseofIEC601-1.Thescopeandobjectgiveninclause1ofIEC601-1:1988apply,exceptthat1,1shallbereplacedbythefollowing:ThisInternationalStandardspecifiessafetyrequirementsforcontinuous-flowoxygenconcentrators,asdefinedin1.3.8(inthisInternationalStandard).ThisInternationalStandarddoesnotapplytooxygenconcentratorsintendedtosupplygastoseveralpatientsviaapipedmedicalgasinstallationortothoseintendedforuseinthepresenceofflammableanaestheticand/orcleaningagents.ThescopeofthisInternationalStandardisnotrestrictedtomembraneoxygenconcentratorsandpressureswingabsorbers(seeIntroduction),asalternativemethodsofconcentratingoxygenmaybecomeavailableanditisnotintendedthatthisInternationalStandardshouldrestrictfuturedevelopments.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:36P.;A4
【正文语种】:英语
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