作者:标准资料网 时间:2024-05-21 00:38:49   浏览:9220   来源:标准资料网

【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