【英文标准名称】:Sterilizersformedicalpurposes-Ethyleneoxidesterilizers-Requirementsandtestmethods(includesAmendmentA1:2009);EnglishversionofDINEN1422:2009-08
【原文标准名称】:医用灭菌器.环氧乙烷灭菌器.要求和试验方法(包括修改件A1-2009).英文版本DINEN1422-2009-08
【标准号】:DINEN1422-2009
【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】:通气;轴承;生物危害;灭菌容量;内室;收费;阻气门;闭塞物;组件;冷凝物;状态调节;连接;结构要求;容器;控制;控制装置;控制功能;协调;周期;定义;密度;尺寸;门;双道门;干燥度;电气装置;电驱动装置;电磁学;环境影响;设备;设备安全性;环氧乙烷;给水;过滤器;冲洗;储气瓶;气体灭菌器;气体;垫圈;手动的;热学;湿度;杂质;指示装置;惰性气体;信息;使用说明书;仪器;干扰抑制;干扰;作标记;材料;最大值;测量;测量技术;医疗器械;医疗设备;医学科学;操作说明书;操作;过热;性能;性能试验;相位;管道;电动的;压力;压力容器;公共卫生;记录仪器;可靠性;安全性;安全工程;安全性要求;抽样方法;螺纹件;传感器;操作程序;声音;规范;规范(验收);灭菌(产生率控制);灭菌(卫生学);灭菌器;灭菌气体;储存;供应;符号;水箱;温度;试验;隔热;热电的;时间;运输;真空的;蒸气;通风;水
【英文主题词】:Aeration;Bearings;Biologicalhazards;Capabilityofsterilization;Chambers;Charge;Chokes;Closures;Components;Condensates;Conditioning;Connections;Constructionrequirements;Containers;Control;Controldevices;Controlfunctions;Coordination;Cycle;Definitions;Density;Dimensions;Doors;Doubledoors;Dryness;Electricalinstallations;Electrically-operateddevices;Electromagnetism;Environmentaleffect;Equipment;Equipmentsafety;Ethyleneoxide;Feed-waters;Filters;Flushing;Gascylinders;Gassterilizers;Gases;Gaskets;Handoperated;Heat;Humidity;Impurities;Indicatingdevices;Inertgases;Information;Instructionsforuse;Instruments;Interferencesuppression;Interferences;Marking;Materials;Maximumvalues;Measurement;Measuringtechniques;Medicaldevices;Medicalequipment;Medicalsciences;Operatinginstructions;Operation;Overheating;Performance;Performancetesting;Phases;Pipelines;Power-operated;Pressure;Pressurevessels;Publichealth;Recordinginstruments;Reliability;Safety;Safetyengineering;Safetyrequirements;Samplingmethods;Screwings;Sensors;Sequenceofoperations;Sound;Specification;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizers;Sterilizinggases;Storage;Supply;Symbols;Tanks(containers);Temperature;Testing;Thermalinsulation;Thermoelectric;Time;Transport;Vacuum;Vapours;Ventilations;Water
【摘要】:1.1ThisEuropeanstandardspecifiestheminimumperformancerequirementsandtestmethodsoftwotypesofsterilizersemployingethyleneoxidegasasthesterilant,eitherasapuregasorinadmixturewithothergases(whethersuppliedreadymixedormixedatthepointofuse)inatemporarilysealedchamber.Thesesterilizersareintendedtobeusedformedical,dental,pharmaceutical,veterinaryandindustrialorrelatedpurposes.ThetwotypesofsterilizershavebeendesignatedTypeAandTypeBrespectivelyusingthefollowingcriteria:--TypeAsterilizersarecapableofbeingprogrammedbytheuser;--TypeBsterilizersareoflimitedsizeandprovidedwithoneormorepre-setoperatingcycleswhichcannotbevariedbytheuser.Theclausesofthisstandardapplytobothtypesofsterilizerunlessitisspecificallyindicatedwithintheclausethatitappliesonlytooneofthetypesinparticular.1.2Thisstandardincludesminimumperformanceandconstructionrequirementsforsterilizersworkingaboveorbelowatmosphericpressure:--Toensurethattheprocessiscapableofbeingusedtosterilizemedicalproducts;--Fortheequipmentandcontrolsnecessarytopermitvalidationandmonitoringofthesterilizationprocess.1.3Thisstandarddoesnotspecifythosetestswhicharenecessarytodeterminetheprobabilityofaprocessedproductbeingsterile,northeroutinequalitycontroltestsrequiredpriortoreleaseofsterileproduct.ThesetopicsareaddressedinEN550.1.4Thisstandarddoesnotspecifytheproceduresandequipmentwhichcanbeusedtoimprovetheefficacyand/orefficiencyoftheprocessbeforeorafterthesterilizationcycle.1.5ConsiderationsofoperatorsafetyareaddressedinEN61010-1:A2andIEC1010-2-042.1.6Thisstandardisapplicablewhen:a)specifiedinacontractforsupplyofanethyleneoxidesterilizer;or,b)asterilizermanufacturerdeclarescompliancewhenintendingtosupplyanethyleneoxidesterilizer.ThisstandardisnotintendedasachecklistforsuitabilityofanexistingethyleneoxidesterilizerwhenassessingcompliancewithEN550.
【中国标准分类号】:C46
【国际标准分类号】:11_080_10
【页数】:58P.;A4
【正文语种】:英语