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【英文标准名称】:Medicalsuctionequipment-Part1:Electricallypoweredsuctionequipment-Safetyrequirements(ISO10079-1:1999);EnglishversionofDINENISO10079-1:2009-07
【原文标准名称】:医用抽吸设备.第1部分:电动抽吸设备的安全要求(ISO10079-1:1999),DINENISO10079-1:2009-07的英文版本
【标准号】:DINENISO10079-1-2009
【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】:事故预防;阻升;α辐射;α辐射线;使用;应用;组装;蓄电池供电;β辐射;壳体;充电;清洁处理;兼容性;可混用性;元部件;组件;触点;容器;集装箱;;转角;封盖物;缺陷与故障;缺陷;定义;耐久性;介电强度;消毒;接地导线;接地线端子;边;效率;电气器具;电器具;电器;电的;电气的;医用电气设备;电气安全;电磁兼容性;静电学;电磁兼容性;EMC;外壳;能量;环境条件;评定;评估;防火;防火;火灾危险;防火安全;流动;γ辐射;危害;气体环境;高温防护;液压装置;红外线辐射;输入电流;仪器;激光束;布置;泄漏量;极限;液体;;电力网供电;质量(物质);材料;措施;力学;医疗器械;医疗设备;医疗技术学;药用植物;微波炉辐射;最低要求;潮气;中子射线;噪声;操作;;溢水口;纸;;病人;性能;气动力学;便携的;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;公共卫生;辐射防护;警告;危险管理;安全;安全要求;分离;声音;声能;规范(验收);稳定性试验;稳定性;灭菌;材料强度;应力;吸引器具(医疗);吸引设备;表面;;温度;试验组织;热防护;超声波学;紫外线辐射;应用;使用;振动;;X射线
【英文主题词】:Accidentprevention;Alpharadiation;Applications;Assembling;Batterieoperation;Betaradiation;Bodies;Chargings;Cleaning;Compatibility;Components;Contact;Containers;Continuouscurrent;Corners;Covers;Defects;Definitions;Dielectricstrength;Disinfections;Earthconductors;Earthingconductorterminations;Edge;Efficiency;Electricappliances;Electrical;Electricalmedicalequipment;Electricalsafety;Electromagneticcompatibility;Electrostatics;EMC;Enclosures;Energy;Environmentalconditions;Evaluations;Fireprevention;Fireprotection;Firerisks;Firesafety;Flows;Gamma-radiation;Hazards;Heatprotection;Hydraulics;Infraredradiation;Inputcurrent;Instruments;Laserbeams;Layout;Leakage;Limitations;Liquids;Luminousradiation;Mainspowersupply;Mass;Materials;Measure;Mechanics;Medicaldevices;Medicalequipment;Medicaltechnology;Medicinalplants;Microwaveradiation;Minimumrequirements;Moisture;Neutronradiation;Noise;Operation;Outlets;Overflows;Paper;Patientauxiliarycurrent;Patients;Performance;Pneumatics;Portable;Potentialequalization;Powerconsumption;Precision;Pressure;Pressurevessels;Protection;Protectionagainstelectricshocks;Protectioncoverings;Protectivedevices;Publichealth;Radiationprotection;Safety;Safetyrequirements;Separation;Sound;Soundenergy;Specification(approval);Stability;Sterilization(hygiene);Strengthofmaterials;Stress;Suctionapparatus(medical);Suctionequipment;Surfaces;Systemearthing;Temperature;Testset-ups;Thermalprotection;Ultrasonics;Ultravioletradiation;Use;Vibrations;Workingdata;X-rays
【摘要】:ThispartoftSO10079specifiesminimumsafetyandperformancerequirementsformedicalandsurgicalsuctionequipment(seeFigure1)forhealthcarefacilitiessuchashospitals,fordomiciliarycareofpatientsandforfieldan~transportuse.Althoughsuchequipmentmaybedrivenbycentrallypoweredpipedvacuumsystems,compressedgasesantelectricity,orbemanuallypoweredforavarietyofapplications,thispartofISO10079addressesonlymain~electricity-andbattery-poweredsuctionequipment.NOTESeealsoannexMinthispartofISO10079.ISO10079-1isoneofaseriesofInternationalStandardsbasedonIEC60601-1:1988;inIEC60601-1(th~"GeneralStandard"),thistypeofInternationalStandardisreferredtoasa"ParticularStandard".Asstatedin1.3oIEC60601-1:1988,therequirementsofthispartofISO10079takeprecedenceoverthoseofIEC60601-1.Thescopeandobjectgiveninclause1ofIEC60601-1:1988apply,exceptthat1.1shallbereplacedbyth~following:ThispartofISO10079isnotapplicableto:a)centralpowersupply(byvacuum/compressedairgeneration),pipingsystemsofvehiclesandbuildingsandwallconnectors;b)cathetertubes,drains,curettesandsuctiontips;c)syringes;d)dentalsuctionequipment;e)wastegasscavengingsystems;f)laboratorysuction;g)autotransfusionsystems;h)passiveurinarydrainage;i)closedsystemsforwounddrainage;j)gravitygastricdrainage;k)orallyoperatedmucousextractors;I)suctionequipmentwherethecollectioncontainerisdownstreamofthevacuumpump;m)equipmentmarkedassuctionunitforpermanenttracheostomy;n)ventouse(obstetric)equipment;o)neonatalmucousextractors;p)suctionequipmentmarkedforendoscopicuseonly.
【中国标准分类号】:C46
【国际标准分类号】:11_040_10
【页数】:39P.;A4
【正文语种】:英语