BS EN 867-5-2001 消毒器用非生物系统.B类和S类小型消毒器的性能试验时使用的指示剂系统和处理设备规范
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【英文标准名称】:Non-biologicalsystemsforuseinsterilizers-SpecificationforindicatorsystemsandprocesschallengedevicesforuseinperformancetestingforsmallsterilizersTypeBandTypeS
【原文标准名称】:消毒器用非生物系统.B类和S类小型消毒器的性能试验时使用的指示剂系统和处理设备规范
【标准号】:BSEN867-5-2001
【标准状态】:现行
【国别】:英国
【发布日期】:2001-10-18
【实施或试行日期】:2001-10-18
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:灭菌;性能试验;灭菌器;化学指示剂;性能;蒸汽灭菌器;医疗设备;化学试剂
【英文主题词】:
【摘要】:ThisEuropeanStandardspecifiestheperformancerequirementsandtestmethodsfornon-biologicalindicatorsystems,includingtheprocesschallengedeviceswithinwhichtheyareintendedtofunction,tobeusedfortestingthesteampenetrationperformanceofsmallsteamsterilizers,TypeBorTypeSwhereappropriate.ThetestsystemsspecifiedareintendedforuseonlyinsmallsteamsterilizersTypeBconformingtoprEN13060-2andhavingausablechamberspacegreaterthan10IandforsmallsteamsterilizersTypeSconformingtoprEN13060-4alsohavingausablechamberspacegreaterthan5I.Non-biologicalindicatorsystemsandtheassociateprocesschallengedevicesarespecifiedforvarioustypesofload.Thepossibleloadsareconsideredintwoclasses:Porousloads,whichcanbewrappedorunwrapped,orhollowinstrumentloads,whichalsocanbewrappedorunwrapped.TherelevantsectionofthisEuropeanStandardonporousloadsspecifiestherequirementsfor:-astandardprocesschallengedevicetobeusedinthesmallloadtestforporousloadsinsmallsteamsterilizers;-anindicatorsystemforuseintheporousloadprocesschallengedevice.AnindicatorforthispurposeisaClassBindicatorasdescribedinEN867-1.-anindicatoremployinganalternativeprocesschallengedeviceequivalenttotheporousloadprocesschallengedevice.TherelevantsectionofthisEuropeanStandardonhollowinstrumentsspecifiestherequirementsfor:-hollowloadprocesschallengedevicestobeusedtosimulatehollowinstrumentloadsasdefinedinprEN13060-4;-anindicatorsystem,foruseinoneofthehollowloadprocesschallengedevice,forassessingsteampenetrationinawrappedloadofhollowinstruments.AnindicatorforthispurposeisaClassBindicatorasdescribedinEN867-1.Theprocesschallengedevicesdescribedinthisstandardareintendedforuseonlyinsterilizersofsufficientsizetoaccommodatetheprocesschallengedevicewithnopartoftheprocesschallengedevicecloserthan20mmfromthevesselwall;inthecaseoftheporousloadprocesschallengedevicethetotalinternalvolumeofthevesselisnotlessthan10I
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:28P;A4
【正文语种】:英语
【原文标准名称】:消毒器用非生物系统.B类和S类小型消毒器的性能试验时使用的指示剂系统和处理设备规范
【标准号】:BSEN867-5-2001
【标准状态】:现行
【国别】:英国
【发布日期】:2001-10-18
【实施或试行日期】:2001-10-18
【发布单位】:英国标准学会(BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:灭菌;性能试验;灭菌器;化学指示剂;性能;蒸汽灭菌器;医疗设备;化学试剂
【英文主题词】:
【摘要】:ThisEuropeanStandardspecifiestheperformancerequirementsandtestmethodsfornon-biologicalindicatorsystems,includingtheprocesschallengedeviceswithinwhichtheyareintendedtofunction,tobeusedfortestingthesteampenetrationperformanceofsmallsteamsterilizers,TypeBorTypeSwhereappropriate.ThetestsystemsspecifiedareintendedforuseonlyinsmallsteamsterilizersTypeBconformingtoprEN13060-2andhavingausablechamberspacegreaterthan10IandforsmallsteamsterilizersTypeSconformingtoprEN13060-4alsohavingausablechamberspacegreaterthan5I.Non-biologicalindicatorsystemsandtheassociateprocesschallengedevicesarespecifiedforvarioustypesofload.Thepossibleloadsareconsideredintwoclasses:Porousloads,whichcanbewrappedorunwrapped,orhollowinstrumentloads,whichalsocanbewrappedorunwrapped.TherelevantsectionofthisEuropeanStandardonporousloadsspecifiestherequirementsfor:-astandardprocesschallengedevicetobeusedinthesmallloadtestforporousloadsinsmallsteamsterilizers;-anindicatorsystemforuseintheporousloadprocesschallengedevice.AnindicatorforthispurposeisaClassBindicatorasdescribedinEN867-1.-anindicatoremployinganalternativeprocesschallengedeviceequivalenttotheporousloadprocesschallengedevice.TherelevantsectionofthisEuropeanStandardonhollowinstrumentsspecifiestherequirementsfor:-hollowloadprocesschallengedevicestobeusedtosimulatehollowinstrumentloadsasdefinedinprEN13060-4;-anindicatorsystem,foruseinoneofthehollowloadprocesschallengedevice,forassessingsteampenetrationinawrappedloadofhollowinstruments.AnindicatorforthispurposeisaClassBindicatorasdescribedinEN867-1.Theprocesschallengedevicesdescribedinthisstandardareintendedforuseonlyinsterilizersofsufficientsizetoaccommodatetheprocesschallengedevicewithnopartoftheprocesschallengedevicecloserthan20mmfromthevesselwall;inthecaseoftheporousloadprocesschallengedevicethetotalinternalvolumeofthevesselisnotlessthan10I
【中国标准分类号】:C47
【国际标准分类号】:11_080_20
【页数】:28P;A4
【正文语种】:英语
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