【英文标准名称】:Sterilizationofhealthcareproducts.Liquidchemicalsterilizingagentsforsingle-usemedicaldevicesutilizinganimaltissuesandtheirderivatives.Requirementsforcharacterization,development,validationandroutinecontrolofasterilizationproce
【原文标准名称】:医疗保健产品的无菌加工.动物组织及其衍生产品制单次使用医疗器械用液体化学消毒剂.医疗器械灭菌工艺的特性描述,开发,确认和常规控制要求
【标准号】:BSENISO14160-2011
【标准状态】:现行
【国别】:英国
【发布日期】:2011-07-31
【实施或试行日期】:2011-07-31
【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】:Animal;Animalproducts;Aseptic;Bacterialcount;Biologicalhazards;Calibration;Certification;Checks;Chemical;Chemicals;Clearing;Compatibility;Definitions;Developments;Disposable;Disposables;Efficiency;Equipmentforsingleuse;Evaluations;Fabrics;Germs;Guidebooks;Incubation;Information;Insulations;Kinetics;Liquid;Liquidmaterials;Liquids;Loading;Media;Medicaldevices;Medicalproducts;Methods;Microbiological;Neutralization;Performance;Personnel;Production;Products;Screening-method;Sterileequipment;Sterilization(hygiene);Surveillance(approval);Training;Use;Validation
【摘要】:ThisInternationalStandardspecifiesrequirementsforthecharacterizationofaliquidchemicalsterilizingagentandforthedevelopment,validation,processcontrolandmonitoringofsterilizationbyliquidchemicalsterilizingagentsofsingle-usemedicaldevicescomprising,inwholeorinpart,materialsofanimalorigin.ThisInternationalStandardcoversthecontrolofrisksarisingfromcontaminationwithbacteriaandfungibyapplicationofaliquidchemicalsterilizationprocess.Risksassociatedwithothermicroorganismscanbeassessedusingothermethods(seeNote1).ThisInternationalStandardisnotapplicabletomaterialofhumanorigin.ThisInternationalStandarddoesnotdescribemethodsforthevalidationoftheinactivationofvirusesandtransmissiblespongiformencephalopathy(TSE)agents(seeNote2).ThisInternationalStandarddoesnotdescribemethodsforvalidationoftheinactivationoreliminationofprotozoaandparasites.TherequirementsforvalidationandroutinecontroldescribedinthisInternationalStandardareonlyapplicabletothedefinedsterilizationprocessofamedicaldevice,whichisperformedafterthemanufacturingprocess,anddonottakeaccountofthelethaleffectsofotherbioburdenreductionsteps(seeNote4).ThisInternationalStandarddoesnotspecifyteststoestablishtheeffectsofanychosensterilizationprocessuponthefitnessforuseofthemedicaldevice(seeNote5).ThisInternationalStandarddoesnotcoverthelevelofresidualsterilizingagentwithinmedicaldevices(seeNote6).ThisInternationalStandarddoesnotdescribeaqualitymanagementsystemforthecontrolofallstagesofmanufacture(seeNote7).NOTE1Thepriorapplicationofriskmanagementprinciplestomedicaldevicesutilizinganimaltissues,asdescribedinISO22442-1,isimportant.NOTE2LiquidchemicalsterilizingagentstraditionallyemployedtosterilizeanimaltissuesinmedicaldevicesmightnotbeeffectiveininactivatingthecausativeagentsofTSEsuchasbovinespongiformencephalopathy(BSE),orscrapie.SatisfactoryvalidationinaccordancewiththisInternationalStandarddoesnotnecessarilydemonstrateinactivationofinfectiveagentsofthistype.Riskcontrolsrelatedtosourcing,collectionandhandlingofanimalmaterialsaredescribedinISO22442-2.NOTE3Thevalidationoftheinactivation,elimination,oreliminationandinactivationofvirusesandTSEagentsisdescribedinISO22442-3.NOTE4Manufacturingprocessesformedicaldevicescontaininganimaltissuesfrequentlyincludeexposuretochemicalagentswhichcansignificantlyreducethebioburdenonthemedicaldevice.Followingthemanufacturingprocess,amedicaldeviceisexposedtoadefinedsterilizationprocess.NOTE5Suchtestingisacrucialpartofthedesignanddevelopmentofamedicaldevice.NOTE6ISO10993-17specifiesamethodtoestablishallowablelimitsforresiduesofsterilizingagents.NOTE7Standardsforqualitymanagementsystems(seeISO13485)canbeusedinthecontrolofallstagesofmanufactureincludingthesterilizationprocess.
【中国标准分类号】:C10
【国际标准分类号】:11_080_01
【页数】:44P.;A4
【正文语种】:英语