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【英文标准名称】:Sterilizersformedicalpurposes-Ethyleneoxidesterilizers-Requirementsandtestmethods
【原文标准名称】:医用灭菌器.氧乙烯灭菌器.要求和试验方法
【标准号】:BSEN1422-1998
【标准状态】:作废
【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】:压力计;水;储存;尺寸;数学计算;温度计;性能试验;漏泄试验;污染物;试验设备;控制装置;密封件;门;杂质;表面处理;组件;管;设备安全;工业的;气体分析;隔热;分类系统;作标记;牙科设备;设计;环氧乙烷;温度测量;定型试验;灭菌;空气;性能;氧化乙烯;气体灭菌器;使用说明;蒸汽;声学测量;阀门;信号装置;体温计;灭菌器;制药技术;联锁装置;兽医设备;医疗设备;记录仪表;测头;元部件
【英文主题词】:Capabilityofsterilization;Components;Constructionrequirements;Control;Definition;Definitions;Dimensions;Doors;Electricalinstallations;Electrically-operateddevices;Equipment;Equipmentsafety;Ethyleneoxide;Gassterilizers;Gases;Instructionsforuse;Interferencesuppression;Marking;Materials;Medicalequipment;Medicalsciences;Operatinginstructions;Performance;Performancetesting;Pipelines;Publichealth;Safety;Safetyengineering;Safetyrequirements;Screwings;Specification;Specification(approval);Sterilization(birthcontrol);Sterilization(hygiene);Sterilizers;Sterilizinggases;Symbols;Testing;Thermalinsulation
【摘要】:1ThisEuropeanStandardspecifiestheminimumperformancerequirementsandtestmethodsoftwotypesofsterilizersemployingethyleneoxidegasasthesterilant,eitherasapuregasorinadmixturewithothergases(whethersuppliedreadymixedormixedatthepointofuse)inatemporarilysealedchamber.Thesesterilizersareintendedtobeusedformedical,dental,pharmaceutical,veterinaryandindustrialorrelatedpurposes.ThetwotypesofsterilizershavebeendesignatedTypeAandTypeBrespectivelyusingthefollowingcriteria.—TypeAsterilizersarecapableofbeingprogrammedbytheuser;—TypeBsterilizersareoflimitedsizeandprovidedwithoneormorepresetoperatingcycleswhichcannotbevariedbytheuser.Theclausesofthisstandardapplytobothtypesofsterilizersunlessitisspecificallyindicatedwithintheclausethatitappliesonlytooneofthetypesinparticular.2Thisstandardincludesminimumperformanceandconstructionrequirementsforsterilizersworkingaboveorbelowatmosphericpressure:—toensurethattheprocessiscapableofbeingusedtosterilizemedicalproducts;—fortheequipmentandcontrolsnecessarytopermitvalidationandmonitoringofthesterilizationprocess.3Thisstandarddoesnotspecifythosetestswhicharenecessarytodeterminetheprobabilityofaprocessedproductbeingsterile,northeroutinequalitycontroltestsrequiredpriortoreleaseofsterileproduct.ThesetopicsareaddressedinEN550.4Thisstandarddoesnotspecifytheproceduresandequipmentwhichcanbeusedtoimprovetheefficacyand/orefficiencyoftheprocessbeforeorafterthesterilizationcycle.5ConsiderationsofoperatorsafetyareaddressedinEN61010-1+A2andIEC1010-2-042.6Thisstandardisapplicablewhen:a)specifiedinacontractforsupplyofanethyleneoxidesterilizer;orb)asterilizermanufacturerdeclarescompliancewhenintendingtosupplyanethyleneoxidesterilizer.ThisstandardisnotintendedasachecklistforsuitabilityofanexistingethyleneoxidesterilizerwhenassessingcompliancewithEN550.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:44P.;A4
【正文语种】:英语