DIN EN 14180-2003 医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验

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【英文标准名称】:Sterilizersformedicalpurposes-Lowtemperaturesteamandformaldehydesterilizers-Requirementsandtesting;GermanversionEN14180:2003
【原文标准名称】:医用灭菌器.低温蒸汽和甲醛灭菌器.要求和试验
【标准号】:DINEN14180-2003
【标准状态】:作废
【国别】:德国
【发布日期】:2003-10
【实施或试行日期】:
【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】:性能要求;气体灭菌器;尺寸;声功率;医疗设备;灭菌;甲醛;灭菌器;声级;使用说明;安全工程;蒸汽灭菌器;信息;低温;医疗产品;蒸气;医疗技术学;方法;输出测定;定义;试验;医学科学;作标记;设备安全;材料;安全要求;规范(验收);设计
【英文主题词】:Definitions;Design;Dimensions;Equipmentsafety;Formaldehyde;Gassterilizers;Information;Instructionsforuse;Lowtemperatures;Marking;Materials;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Medicaltechnology;Methods;Outputdetermination;Performancerequirements;Safetyengineering;Safetyrequirements;Soundlevel;Soundpower;Specification(approval);Steamsterilizers;Sterilization(hygiene);Sterilizers;Testing;Vapours
【摘要】:ThisstandardspecifiesrequirementsandtestsforLTSFsterilizers,whichuseamixtureoflowtemperaturesteamandformaldehydeassterilizingagent,andwhichareworkingbelowambientpressureonly.Thesesterilizersareprimarilyusedforsterilizationofheatlabilemedicaldevicesinhealthcarefacilities.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:56P.;A4
【正文语种】:德语


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【英文标准名称】:StandardTestMethodforQuantitativeSporicidalThree-StepMethod(TSM)toDetermineSporicidalEfficacyofLiquids,LiquidSprays,andVapororGasesonContaminatedCarrierSurfaces
【原文标准名称】:在受污染的载体表面测定液体、喷液、蒸气或气体的杀孢子效率的定量杀孢子三步法的标准试验方法
【标准号】:ASTME2414-2005
【标准状态】:现行
【国别】:
【发布日期】:2005
【实施或试行日期】:
【发布单位】:美国材料与试验协会(US-ASTM)
【起草单位】:E54.03
【标准类型】:(TestMethod)
【标准水平】:()
【中文主题词】:灭菌;步骤;喷雾;承载装置;效率;气体;定量的;表面;液体;蒸气;消毒;卫生学;试验
【英文主题词】:biodefense;biologicalprotection;carriersurfaces;decontamination;disinfection;liquidsterilization;microbicidaleffect;sporicidalefficacy
【摘要】:Thequantitativemicromethoddescribedhereinwasdesignedtofulfillthefollowingspecifications:4.1.1Tobequantitative(thenumberofviablesporesloadedintocarriersisdeterminedbythesporesquantitativelyrecoveredinthecontrols),4.1.2Sensitive(sporicidalactivitycanbeaccuratelymeasuredupto7Log10inactivation,seeSection12),4.1.3Reproducible(standarddeviationofsporekillingissmallerthan1Logandusuallycloserto1/10ofaLog,seeSection12),4.1.4Rapid(exceptfortheovernightculture,itcanbecompletedwithin4h),4.1.5Economical(beingamicromethod,itusescarriers,dishes,andplasticwaresthataresmall,inexpensive,anddisposable),and4.1.6Environmentallyfriendly(usingamicrolitrevolumeofdisinfectantagent,thetestmethodcanbeconsideredforallpracticalpurposesasnondestructive).1.1Thistestmethoddeterminestheefficacyofsporicidalagentsonmicroorganismsdriedonthesurfaceofsolidcarriers.1.2Thistestmethodcanbeusedtoevaluatesporicidalproducts(ordecontaminant,disinfectant,andsoforth),suspected,claimed,orassumedtohavesporicidalactivity.Thistestmethodallows:1.2.1Establishingthesporicidalefficacyofdifferentdisinfectants;1.2.2Identifyingtheeffect,ifany,ofthesurfacematerialsonsporicidalefficacy;and1.2.3Comparingtherelativeresistancetodisinfectionofdifferentmicrobialspeciesorstrains.1.3ThevaluesstatedinSIunitsaretoberegardedasthestandard.1.4Strictadherencetotheprotocolisnecessaryforthevalidityofthetestresults.1.5Followallthesafetyguidanceoftheinstitutioninwhichthetestingisbeingconducted.Thisstandarddoesnotpurporttoaddressallofthesafetyconcerns,ifany,associatedwithitsuse.Itistheresponsibilityoftheuserofthisstandardtoestablishappropriatesafetyandhealthpracticesanddeterminetheapplicabilityofregulatorylimitationspriortouse.
【中国标准分类号】:Z04
【国际标准分类号】:11_080_01
【页数】:9P.;A4
【正文语种】: