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【英文标准名称】:Comparisonofworldwideescalatorandmovingwalksafetystandards-Part1:Rulebyrulecomparison
【原文标准名称】:全球范围电梯和自动走道安全标准对比.第1部分:规则对比原则
【标准号】:ISO/TR14799-1-2005
【标准状态】:现行
【国别】:
【发布日期】:2005-08
【实施或试行日期】:
【发布单位】:国际标准化组织(ISO)
【起草单位】:ISO/TC178
【标准类型】:()
【标准水平】:()
【中文主题词】:美洲;澳大利亚;比较;定义;设计;差值;自动电梯;欧洲;日本;南朝鲜;物料搬运设备;可移动路面;载客传送带;俄国;安全标准;规范(验收);标准化
【英文主题词】:
【摘要】:ThisTechnicalReportconsistsofacomparisonoftherequirementsofselectedtopicsascoveredbythefollowingworld-widesafetystandards(excludinglocaldeviations):a)Europe(CEN)–EN115;Safetyrulesfortheconstructionandinstallationofescalatorsandpassengerconveyors(EditionJanuary1995andamendmentA1:1998);b)USA–ASMEA17.1-1996;SafetyCodeforElevatorsandEscalatorsNOTETherequirementsforCanada(B44)aregenerallythesameasfortheUSA.Anydifferencesarestatedinthetext.c)Australia–AS1735parts5and6forescalatorsandmovingwalks(Edition1996);d)Japan–SafetyrequirementsmainlycomprisedofBuildingStandardLawEnforcementOrder(BSLJ-EO),NotificationsofMinistryofConstruction(MOC-N,No.1110-1981)anddraftofJapanElevatorAssociationStandard(JEAS);e)Russia–PUBEE10-77-94,Regulationsfortheinstallationandsafeuseofescalators(Edition1995);f)Korea–TheElevatorInspectionStandards,KATS2001-414EditionaccordingtotheKoreaElevatorLaw4482,bothcoverthesafetyrequirementsontheescalatorandmovingwalk.Itshouldbenotedthatinadditiontotheabovelistedstandardsandotherregulations,escalatorsandmovingwalksmayberequiredtoconformtotherequirementsofotherstandardsasappropriate.WhereISO/TC178/WG5wasawareofthesestandardstheyarementionedinthebibliography.
【中国标准分类号】:Q78
【国际标准分类号】:91_140_90
【页数】:226P;A4
【正文语种】:英语


【英文标准名称】:Sterilizationofmedicaldevices.Lowtemperaturesteamandformaldehyde.Requirementsfordevelopment,validationandroutinecontrolofasterilizationprocessformedicaldevices
【原文标准名称】:医疗设备消毒.低温蒸汽和甲醛.医疗设备消毒流程的开发,确认和常规控制要求
【标准号】:BSENISO25424-2011
【标准状态】:现行
【国别】:英国
【发布日期】:2011-08-31
【实施或试行日期】:2011-08-31
【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】:
【英文主题词】:Applications;Definitions;Developments;Formaldehyde;Hygiene;Lowtemperatures;Medicaldevices;Medicalequipment;Medicalproducts;Medicalsciences;Packages;Qualitymanagement;Specification(approval);Steamsterilization;Sterilization(hygiene);Use;Validation;Vapours
【摘要】:1.1Inclusions1.1.1ThisEuropeanStandardspecifiesrequirementsforthedevelopment,validationandroutinecontrolofaLowTemperatureSteamandFormaldehyde(LTSF)sterilizationprocessformedicaldevices.NOTEAlthoughthescopeofthisstandardislimitedtomedicaldevices,itspecifiesrequirementsandprovidesguidancethatmaybeapplicabletootherproductsandequipment.1.1.2ThisEuropeanStandardisintendedtobeappliedbyprocessdevelopers,manufacturersofsterilizationequipment,manufacturersofmedicaldevicestobesterilizedandtheorganizationswithresponsibilityforsterilizingmedicaldevices.(SeeENISO14937:2000,TableE.1)1.1.3ThisEuropeanStandardcoverssterilizationprocesseswhichuseamixtureoflowtemperaturesteamandformaldehydeassterilant,andwhichareworkingbelowambientpressureonly.1.2Exclusions1.2.1Sterilizationprocessesvalidatedandcontrolledinaccordancewiththerequirementsofthisstandardshouldnotbeassumedtobeeffectiveininactivatingthecausativeagentsofspongiformencephalopathiessuchasscrapie,bovinespongiformencephalopathyandCreutzfeld-Jakobdisease.Specificrecommendationshavebeenproducedinparticularcountriesfortheprocessingofmaterialspotentiallycontaminatedwiththeseagents.1.2.2Thisstandarddoesnotspecifyrequirementsfordesignatingamedicaldeviceas“STERILE”.SuchrequirementsaregiveninEN556-1.1.2.3Thisstandarddoesnotspecifyaqualitymanagementsystemforthecontrolofallstagesofproductionofmedicaldevices.NOTEItisnotarequirementofthisstandardtohaveacompletequalitymanagementsystemduringmanufactureorreprocessing,butthoseelementsofsuchasystemthatarerequiredarenormativelyreferencedatappropriateplacesinthetext.Attentionisdrawntothestandardsforqualitymanagementsystems(seeENISO13485)thatcontrolallstagesofproductionorreprocessingofmedicaldevicesincludingthesterilizationprocess.FurtherguidanceisgiveninE.2ofENISO14937:2000.1.2.4ThisstandarddoesnotspecifyrequirementsforoccupationalsafetyassociatedwiththedesignandoperationofLTSFsterilizationfacilities.NOTE1SafetyrequirementsforsterilizersarespecifiedinEN61010-2-040.NOTE2Attentionisalsodrawntotheexistenceinsomecountriesofregulationsstipulatingsafetyrequirements.1.2.5ThisEuropeanStandarddoesnotcoveranalyticalmethodsfordetermininglevelsorresiduesofformaldehydeand/oritsreactionproducts.NOTE1AttentionisdrawntoEN14180.NOTE2Attentionisdrawntothepossibleexistenceinsomecountriesofstatutoryregulationspecifyinglimitsforthelevelofformaldehyderesiduesonmedicaldevicesandproducts.1.2.6ThisEuropeanStandarddoesnotcoverpreparatorymeasuresthatmaybenecessarybeforesterilizationsuchascleaning,disinfectionandpacking.NOTEForre-sterilizablemedicaldevices,themanufacturer(s)ofthesedevicesshouldsupplyinformationonthepreparatorymeasures(seeENISO17664).
【中国标准分类号】:C47
【国际标准分类号】:11_080_01
【页数】:54P.;A4
【正文语种】:英语