【英文标准名称】:Washer-disinfectors-Part4:Requirementsandtestsforwasher-disinfectorsemployingchemicaldisinfectionforthermolabileendoscopes(ISO15883-4:2008);GermanversionENISO15883-4:2008
【原文标准名称】:垫圈消毒设备.第4部分:不耐热的内诊镜使用化学消毒的垫圈-消毒设备用要求和试验
【标准号】:DINENISO15883-4-2008
【标准状态】:作废
【国别】:德国
【发布日期】:2008-08
【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】:化学清洗;清洁设备;清洁机;一致性;控制装置;排除污染;定义;消毒设备;消毒器;效率;内窥镜仪器;医疗设备;医学科学;性能;安全;安全规则;安全要求;测试
【英文主题词】:Chemicalcleaning;Cleaningequipment;Cleaningmachines;Conformity;Controldevices;Decontaminations;Definitions;Disinfectionapparatus;Disinfectors;Efficiency;Endoscopicapparatus;Englishlanguage;Medicaldevices;Medicalequipment;Medicalsciences;Performance;Safety;Safetyregulations;Safetyrequirements;Testing
【摘要】:ThispartofISO15883specifiestheparticularrequirements,includingperformance,forwasher-disinfectors(WDs)thatareintendedtobeusedforcleaningandchemicaldisinfectionofthermolabileendoscopes.ThispartofISO15883alsospecifiestheperformancerequirementsforthecleaninganddisinfectionofthewasher-disinfectoranditscomponentsandaccessorieswhichmayberequiredtoachievethenecessaryperformance.Themethods,instrumentationandinstructionsrequiredfortypetesting,workstesting,validation(installation,operationalandperformancequalificationonfirstinstallation),routinecontrolandmonitoringandre-validation,periodicallyandafteressentialrepairs,arealsospecified.NOTEIInaddition,AnnexAgivesguidanceonanappropriatedivisionofresponsibilityfortherangeofactivitiescoveredbythispartofISO15883.NOTE2WDscomplyingwiththispartofISO15883canalsobeusedforcleaningandchemicaldisinfectionofotherthermolabilere-usablemedicaldevicesforwhichthedevicemanufacturerhasrecommendedthismethodofdisinfection.WDscomplyingwiththerequirementsofthispartofISO15883arenotintendedforcleaninganddisinfectionofmedicaldevices,includingendoscopicaccessories,whichareheatstableandcanbedisinfectedorsterilizedbythermalmethods(seeISO15883-1:2006,4.1.5).ThespecifiedperformancerequirementsofthispartofISO15883maynotensuretheinactivationorremovalofthecausativeagent(s)(prioriprotein)oftransmissiblespongiformencephalopathies.NOTE3Ifitisconsideredthatprionproteinmightbepresent,particularcareisneededinthechoiceofdisinfectantsandcleaningagentstoensurethatthechemicalsuseddonotreactwiththeprionproteininamannerthatmayinhibititsremovalorinactivationfromtheloadorwasher-disinfector.ThispartofISO15883canbeusedbyprospectivepurchasersandmanufacturersasthebasisofagreementonthespecificationofWDmanufacturersofendoscopes,cleaningproducts,disinfectingproducts,andalsobyusers.
【中国标准分类号】:C47;Y62
【国际标准分类号】:11_080_10
【页数】:65P.;A4
【正文语种】:德语


MIL-STD-2131, MILITARY STANDARD: LAUNCHER, EJECTION, GUIDED MISSILE, AIRCRAFT, GENERAL DESIGN CRITERIA FOR (04 APR 1983)., The purpose of this document is to provide guidelines for establishing general criteria for the design, development, construction, maintenance and testing of an ejection launcher.