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【英文标准名称】:Respiratorytracthumidifiersformedicaluse-Particularrequirementsforrespiratoryhumidificationsystems(ISO8185:2007);EnglishversionofDINENISO8185:2009-07
【原文标准名称】:医用呼吸道加湿器.呼吸潮湿系统特殊要求(ISO8185:2007),英文版本DINENISO8185:2009-07
【标准号】:DINENISO8185-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-07
【实施或试行日期】:2009-07-01
【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】: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);笔帽;充电;夹件;夹具;分类;清洁处理;颜色;兼容性;可混用性;元部件;组件;连接;连接件;触点;;转角;封盖物;缺陷与故障;缺陷;定义;耐久性;密度;介电强度;放电;卸货;消毒;接地导线;接地线端子;边;电力系统;电击;电气工程;电气安全;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;环境条件;设备安全;蒸发;蒸发器;装满;防火;火灾危险;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;套圈;使用说明;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;处理;惰性气体铠装电弧焊;作标记;质量(物质);测量;医用呼吸器;医疗器械;医疗设备;医疗器械;医学科学;药用植物;潮气;噪声;不可燃的;开口;;溢水口;纸;;;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;营救设备;呼吸作用;警告;危险管理;安全;安全工程;安全要求;传感器;测头;分离;操作程序;火花;规范(验收);规范;稳定性试验;稳定性;灭菌;材料强度;应力;表面;;温度;试验;测试;痕量元素分析;应用;使用;振动;润湿;
【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】:ThisInternationalStandardincludesrequirementsforthebasicsafetyandessentialperformanceofhumidificationsystems,asdefinedin3.6.ThisInternationalStandardalsoincludesrequirementsforindividualdevicesspecifiedforuseinhumidificationsystemssuchasheatedbreathingtubes(heated-wirebreathingtubes)anddevicesintendedtocontroltheseheatedbreathingtubes(heatedbreathingtubecontrollers).ISO5367specifiesothersafetyandperformancerequirementsforbreathingtubes.NOTEHeatedbreathingtubesaremedicalelectricalequipmentandaresubjecttotherequirementsofIEC60601-1.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.ThisInternationalStandardisnotapplicabletonebulizersusedforthedeliveryofdrugstopatientsIntheplanninganddesignofproductswithinthescopeofthisInternationalStandard,itisadvisabletogivedueconsiderationtotheenvironmentalimpactfromtheproductduringitslifecycle.EnvironmentalaspectsareaddressedinAnnexGG.NOTEAdditionalaspectsofenvironmentalimpactareaddressedinISO14971
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:64P.;A4
【正文语种】:英语