BS EN ISO 8185-2009 医用呼吸道加湿器.呼吸加湿系统详细要求
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【英文标准名称】:Respiratorytracthumidifiersformedicaluse.Particularrequirementsforrespiratoryhumidificationsystems
【原文标准名称】:医用呼吸道加湿器.呼吸加湿系统详细要求
【标准号】:BSENISO8185-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:调整设备;麻醉学;麻醉设备;组装;生物适应性;壳体;呼吸装置;呼吸设备;呼吸管;帽(闭塞物);充电;夹件;分类;清洁处理;颜色;兼容性;元部件;连接;触点;恒电流;转角;封盖物;缺陷与故障;定义(术语);密度;介电强度;放电;消毒;接地导线;接地线端子;边;电力系统;电击;电气工程;电气安全性;电学;电磁兼容性;静电学;电磁兼容性(EMC);外壳;能量;焓;环境条件;周围条件;设备安全性;蒸发;蒸发器;装满;防火;火险;柔性管;受液器;压头损失;热传递;湿润剂;加湿器;液压装置;点火;指示;输入电流;检验;使用说明书;仪器;中断;灯;布置;输入线;文字书写;水平;极限;液体;作标记;质量(物质);测量;医用呼吸器;医疗器械;医疗设备;医疗器材;医学科学;药用植物;潮气;噪声;不可燃的;开口;引出端;溢水口;纸;设备部件;患者辅助电流;病人;性能;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);防电击;保护覆盖层;保护装置;救生设备;呼吸作用;安全性;安全性工程;安全性要求;传感器;分离;操作程序;火花;规范(验收);规范;稳定性;灭菌;材料强度;应力;表面;系统接地;温度;测试;使用;振动;润湿;工作数据
【英文主题词】:Adjustingequipment;Anaesthesiology;Anaestheticequipment;Assembling;Biocompatibility;Bodies;Breathingapparatus;Breathingequipment;Breathingtubes;Caps(closures);Chargings;Clamps;Classification;Cleaning;Colour;Compatibility;Components;Connections;Contact;Continuouscurrent;Corners;Covers;Defects;Definitions;Density;Dielectricstrength;Discharge;Disinfections;Earthconductors;Earthingconductorterminations;Edge;Electricpowersystems;Electricshock;Electricalengineering;Electricalsafety;Electricity;Electromagneticcompatibility;Electrostatics;EMC;Enclosures;Energy;Enthalpy;Environmentalcondition;Environmentalconditions;Equipmentsafety;Evaporation;Evaporators;Filling-up;Fireprevention;Firerisks;Flexiblepipes;Fluidreceivers;Headlosses;Heattransfer;Humectants;Humidifiers;Hydraulics;Ignition;Indications;Inputcurrent;Inspection;Instructionsforuse;Instruments;Interruptions;Lamps;Layout;Lead-inwires;Letterings;Level;Limitations;Liquids;Marking;Mass;Measurement;Medicalbreathingapparatus;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalsciences;Medicinalplants;Moisture;Noise;Non-combustible;Openings;Outlets;Overflows;Paper;Partofadevice;Patientauxiliarycurrent;Patients;Performance;Pneumatics;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protection;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Rescueequipment;Respiration;Safety;Safetyengineering;Safetyrequirements;Sensors;Separation;Sequenceofoperations;Spark;Specification(approval);Specifications;Stability;Sterilization(hygiene);Strengthofmaterials;Stress;Surfaces;Systemearthing;Temperature;Testing;Use;Vibrations;Wetting;Workingdata
【摘要】:IEC60601-1:1988,Clause1,applies,exceptasfollows:Amendment(addattheendof1.1):ThisInternationalStandardincludesrequirementsforthebasicsafetyandessentialperformanceofhumidificationsystems,asdefinedin3.6.ThisInternationalStandardalsoincludesrequirementsforindividualdevicesspecifiedforuseinhumidificationsystemssuchasheatedbreathingtubes(heated-wirebreathingtubes)anddevicesintendedtocontroltheseheatedbreathingtubes(heatedbreathingtubecontrollers).ISO5367specifiesothersafetyandperformancerequirementsforbreathingtubes.ThisInternationalStandardalsoincludesrequirementsforactiveHME(heatandmoistureexchanger)devices,whichactivelyaddheatandmoisturetoincreasethehumiditylevelofthegasdeliveredfromtheHMEtothepatient.ThisInternationalStandardisnotapplicabletopassiveHMEs,whichreturnaportionofthepatient'sexpiredmoistureandheattotherespiratorytractduringinspirationwithoutaddingheatandmoisture.ISO9360-1andISO9360-2specifysafetyandperformancerequirementsforpassiveHMEsanddescribemethodsfortestingperformance.Respiratorytracthumidifierscanbegas-powered,electrically-powered,orboth.However,thisInternationalStandardhasbeenpreparedasaParticularStandardbasedonIEC60601-1,whichgivesgeneralrequirementsforallaspectsofsafety,notonlyelectricalsafety,andmanyoftherequirementsarethereforeapplicabletohumidifiersnotpoweredbyelectricity.WherethisInternationalStandardspecifiesthataClauseofIEC60601-1applies,itmeansthattheClauseappliesonlyiftherequirementisrelevanttothehumidificationsystemunderconsideration.ThisInternationalStandardisnotapplicabletodevicescommonlyreferredtoas"roomhumidifiers"orhumidifiersusedinheating,ventilationandairconditioningsystems,orhumidifiersincorporatedintoinfantincubators.ThisInternationalStandardisnotapplicabletonebulizersusedforthedeliveryofdrugstopatients.IntheplanninganddesignofproductswithinthescopeofthisInternationalStandard,itisadvisabletogivedueconsiderationtotheenvironmentalimpactfromtheproductduringitslifecycle.EnvironmentalaspectsareaddressedinAnnexGG.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:66P.;A4
【正文语种】:英语
【原文标准名称】:医用呼吸道加湿器.呼吸加湿系统详细要求
【标准号】:BSENISO8185-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-07-31
【实施或试行日期】:2009-07-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:调整设备;麻醉学;麻醉设备;组装;生物适应性;壳体;呼吸装置;呼吸设备;呼吸管;帽(闭塞物);充电;夹件;分类;清洁处理;颜色;兼容性;元部件;连接;触点;恒电流;转角;封盖物;缺陷与故障;定义(术语);密度;介电强度;放电;消毒;接地导线;接地线端子;边;电力系统;电击;电气工程;电气安全性;电学;电磁兼容性;静电学;电磁兼容性(EMC);外壳;能量;焓;环境条件;周围条件;设备安全性;蒸发;蒸发器;装满;防火;火险;柔性管;受液器;压头损失;热传递;湿润剂;加湿器;液压装置;点火;指示;输入电流;检验;使用说明书;仪器;中断;灯;布置;输入线;文字书写;水平;极限;液体;作标记;质量(物质);测量;医用呼吸器;医疗器械;医疗设备;医疗器材;医学科学;药用植物;潮气;噪声;不可燃的;开口;引出端;溢水口;纸;设备部件;患者辅助电流;病人;性能;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);防电击;保护覆盖层;保护装置;救生设备;呼吸作用;安全性;安全性工程;安全性要求;传感器;分离;操作程序;火花;规范(验收);规范;稳定性;灭菌;材料强度;应力;表面;系统接地;温度;测试;使用;振动;润湿;工作数据
【英文主题词】:Adjustingequipment;Anaesthesiology;Anaestheticequipment;Assembling;Biocompatibility;Bodies;Breathingapparatus;Breathingequipment;Breathingtubes;Caps(closures);Chargings;Clamps;Classification;Cleaning;Colour;Compatibility;Components;Connections;Contact;Continuouscurrent;Corners;Covers;Defects;Definitions;Density;Dielectricstrength;Discharge;Disinfections;Earthconductors;Earthingconductorterminations;Edge;Electricpowersystems;Electricshock;Electricalengineering;Electricalsafety;Electricity;Electromagneticcompatibility;Electrostatics;EMC;Enclosures;Energy;Enthalpy;Environmentalcondition;Environmentalconditions;Equipmentsafety;Evaporation;Evaporators;Filling-up;Fireprevention;Firerisks;Flexiblepipes;Fluidreceivers;Headlosses;Heattransfer;Humectants;Humidifiers;Hydraulics;Ignition;Indications;Inputcurrent;Inspection;Instructionsforuse;Instruments;Interruptions;Lamps;Layout;Lead-inwires;Letterings;Level;Limitations;Liquids;Marking;Mass;Measurement;Medicalbreathingapparatus;Medicaldevices;Medicalequipment;Medicalinstruments;Medicalsciences;Medicinalplants;Moisture;Noise;Non-combustible;Openings;Outlets;Overflows;Paper;Partofadevice;Patientauxiliarycurrent;Patients;Performance;Pneumatics;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protection;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Rescueequipment;Respiration;Safety;Safetyengineering;Safetyrequirements;Sensors;Separation;Sequenceofoperations;Spark;Specification(approval);Specifications;Stability;Sterilization(hygiene);Strengthofmaterials;Stress;Surfaces;Systemearthing;Temperature;Testing;Use;Vibrations;Wetting;Workingdata
【摘要】:IEC60601-1:1988,Clause1,applies,exceptasfollows:Amendment(addattheendof1.1):ThisInternationalStandardincludesrequirementsforthebasicsafetyandessentialperformanceofhumidificationsystems,asdefinedin3.6.ThisInternationalStandardalsoincludesrequirementsforindividualdevicesspecifiedforuseinhumidificationsystemssuchasheatedbreathingtubes(heated-wirebreathingtubes)anddevicesintendedtocontroltheseheatedbreathingtubes(heatedbreathingtubecontrollers).ISO5367specifiesothersafetyandperformancerequirementsforbreathingtubes.ThisInternationalStandardalsoincludesrequirementsforactiveHME(heatandmoistureexchanger)devices,whichactivelyaddheatandmoisturetoincreasethehumiditylevelofthegasdeliveredfromtheHMEtothepatient.ThisInternationalStandardisnotapplicabletopassiveHMEs,whichreturnaportionofthepatient'sexpiredmoistureandheattotherespiratorytractduringinspirationwithoutaddingheatandmoisture.ISO9360-1andISO9360-2specifysafetyandperformancerequirementsforpassiveHMEsanddescribemethodsfortestingperformance.Respiratorytracthumidifierscanbegas-powered,electrically-powered,orboth.However,thisInternationalStandardhasbeenpreparedasaParticularStandardbasedonIEC60601-1,whichgivesgeneralrequirementsforallaspectsofsafety,notonlyelectricalsafety,andmanyoftherequirementsarethereforeapplicabletohumidifiersnotpoweredbyelectricity.WherethisInternationalStandardspecifiesthataClauseofIEC60601-1applies,itmeansthattheClauseappliesonlyiftherequirementisrelevanttothehumidificationsystemunderconsideration.ThisInternationalStandardisnotapplicabletodevicescommonlyreferredtoas"roomhumidifiers"orhumidifiersusedinheating,ventilationandairconditioningsystems,orhumidifiersincorporatedintoinfantincubators.ThisInternationalStandardisnotapplicabletonebulizersusedforthedeliveryofdrugstopatients.IntheplanninganddesignofproductswithinthescopeofthisInternationalStandard,itisadvisabletogivedueconsiderationtotheenvironmentalimpactfromtheproductduringitslifecycle.EnvironmentalaspectsareaddressedinAnnexGG.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:66P.;A4
【正文语种】:英语
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