【英文标准名称】:Washer-disinfectors-Part4:Requirementsandtestsforwasher-disinfectorsemployingchemicaldisinfectionforthermolabileendoscopes(ISO15883-4:2008);EnglishversionofDINENISO15883-4:2009-09
【原文标准名称】:清洗消毒器.第4部分:不耐热的内窥镜使用化学消毒的清洗消毒器的试验和要求(ISO15883-4-2008).英文版本DINENISO15883-4-2009-09
【标准号】:DINENISO15883-4-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-09
【实施或试行日期】:2009-09-01
【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;清洗设备;清洁机;合格;控制装置;去污染;定义(术语);消毒设备;消毒器;效率;内窥镜仪器;英语;医疗器械;医疗器材;医学科学;性能;安全性;安全规则;安全性要求;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)thatareintendedtobeusedforcleaningandchemicaldisinfectionoftnermolabileendoscopes.ThispartofISO15883alsospecifiestheperformancerequirementsforthecleaninganddisinfectionofthewasher-disinfectoranditscomponentsandaccessorieswhichmayberequiredtoachievethenecessaryperformance.Themethods,instrumentationandinstructionsrequiredfortypetesting,workstesting,validation(installation,operationalandperformancequalificationonfirstinstallation),routinecontrolandmonitoringandre-validation.periodicallyandafteressentialrepairs,arealsospecified.NOTE1Inaddition,AnnexAgivesguidanceonanappropriatedivisionofresponsibilityfortherangeofactivitiescoveredbythispartofISO15883.NOTE2WDscomplyingwiththispartofISO15883canalsobeusedforcleaningandchemicaldisinfectionofotherthermolabilere-usablemedicaldevicesforwhichthedevicemanufacturerhasrecommendedthismethodofdisinfectionWDscomplyingwiththerequirementsofthispartofISO15883arenotintendedforcleaninganddisinfectionofmedicaldevices,includingendoscopicaccessories,whichareheatstableandcanbedisinfectedorsterilizedbythermalmethods(seeISO15883-1:2006,4.1.5).ThespecifiedperformancerequirementsofthispartofISO15883maynotensuretheinactivationorremovalofthecausativeagent(s)(prioriprotein)oftransmissiblespongiformencephalopathies.NOTE3Ifitisconsideredthatprioriproteinmightbepresent,particularcareisneededinthechoiceofdisinfectantsandcleaningagentstoensurethatthechemicalsuseddonotreactwiththeprionproteininamannerthatmayinhibititsremovalorinactivationfromtheloadorwasher-disinfector.ThispartofISO15883canbeusedbyprospectivepurchasersandmanufacturersasthebasisofagreementonthespecificationofWDmanufacturersofendoscopes,cleaningproducts,disinfectingproducts,andalsobyusers.
【中国标准分类号】:C47
【国际标准分类号】:11_080_10
【页数】:61P.;A4
【正文语种】:英语


Product Code:SAE ARP5089
Title:Composite Repair Ndt/Ndi Handbook
Issuing Committee:Ams Cacrc Commercial Aircraft Composite Repair Committee
Scope:This document provides background information on the design, application, repair and inspection of composite structures, including metal bonding, used on civil transport aircraft. The objective of this document is to assist inspectors to know where to expect composite and metal bonded parts on the aircraft, to understand the capabilities of current NDT methods and to aid interpretation of inspection results. This document does not contain inspection procedures. It is intended to be informative and should not be used singularly, that is, it does not override any instructions that may be issued within a manufacturer's or operator's published documentation.