【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