ISO 8185-2007 医用呼吸道加湿器.呼吸潮湿系统特殊要求
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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.呼吸潮湿系统特殊要求
【标准号】:ISO8185-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC121
【标准类型】:()
【标准水平】:()
【中文主题词】:麻醉设备;呼吸装置;呼吸设备;呼吸管;分类;定义;电气工程;电气安全;设备安全;蒸发;蒸发器;湿润剂;加湿器;检验;使用说明;文字书写;作标记;医用呼吸器;医疗设备;医疗器械;医学科学;性能;防电击;营救设备;呼吸作用;安全;安全工程;安全要求;规范(验收);规范;测试;试验;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】:IEC60601-1:1988,Clause1,applies,exceptasfollows:Amendment(addattheendof1.1):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.ThisInternationalStandardisnotapplicabletonebulizersusedforthedeliveryofdrugstopatients.IntheplanninganddesignofproductswithinthescopeofthisInternationalStandard,itisadvisabletogivedueconsiderationtotheenvironmentalimpactfromtheproductduringitslifecycle.EnvironmentalaspectsareaddressedinAnnexGG.NOTEAdditionalaspectsofenvironmentalimpactareaddressedinISO14971.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:49P;A4
【正文语种】:英语
【原文标准名称】:医用呼吸道加湿器.呼吸潮湿系统特殊要求
【标准号】:ISO8185-2007
【标准状态】:现行
【国别】:国际
【发布日期】:2007-07
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC121
【标准类型】:()
【标准水平】:()
【中文主题词】:麻醉设备;呼吸装置;呼吸设备;呼吸管;分类;定义;电气工程;电气安全;设备安全;蒸发;蒸发器;湿润剂;加湿器;检验;使用说明;文字书写;作标记;医用呼吸器;医疗设备;医疗器械;医学科学;性能;防电击;营救设备;呼吸作用;安全;安全工程;安全要求;规范(验收);规范;测试;试验;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】:IEC60601-1:1988,Clause1,applies,exceptasfollows:Amendment(addattheendof1.1):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.ThisInternationalStandardisnotapplicabletonebulizersusedforthedeliveryofdrugstopatients.IntheplanninganddesignofproductswithinthescopeofthisInternationalStandard,itisadvisabletogivedueconsiderationtotheenvironmentalimpactfromtheproductduringitslifecycle.EnvironmentalaspectsareaddressedinAnnexGG.NOTEAdditionalaspectsofenvironmentalimpactareaddressedinISO14971.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:49P;A4
【正文语种】:英语
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