【英文标准名称】:Sterilizersformedicalpurposes-Ethyleneoxidesterilizers-Requirementsandtestmethods
【原文标准名称】:医用消毒器.环氧乙烷消毒器.要求和试验方法
【标准号】:BSEN1422-1997+A1-2009
【标准状态】:现行
【国别】:英国
【发布日期】:1998-04-15
【实施或试行日期】:1998-04-15
【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】:通气;轴承;生物危害;消毒能力;内庭;收费;阻气门;闭塞物;组件;冷凝物;状态调节;连接件;结构要求;容器;控制;控制装置;控制功能;合作;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;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;处理;材料;最大值;测量;医疗设备;医学科学;操作说明书;操作;过热;性能;性能测试;相位;管道;电动的;压力;压力容器;公共卫生;记录仪器;可靠度;安全;安全工程;安全要求;抽样方法;螺纹件;传感器;操作程序;声音;规范;规范(验收);绝育;灭菌;灭菌器;灭菌气体;供应;符号;水箱;温度;试验;绝热;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;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;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】:C47
【国际标准分类号】:11_080_10
【页数】:60P.;A4
【正文语种】:英语