workoftheCouncilofEurope莃QUALITYASSURANCEDOCUMENT艿PA/PH/OMCL(07)11DEFCORR莆QUALIFICATIONOFEQUIPMENT芇仪器确认螁ANNEX3:QUALIFICATIONOFUV-VISIBLE莂SPECTROPHOTOMETERS蒆附件3:紫外-可见光分光光度仪的确认蒄Fulldocumenttitleandreference薃文件全名和索引号肁QualificationofEquipment薆Annex3:QualificationofUV-Visiblespectrophotometers袅PA/PH/OMCL(07)mendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLs蚂Dateoffirstadoption蚈首次发行日期螆May2007蚆Dateoforiginalentryintoforce莄首次执行日期蚁July2007袆Dateofentryintoforceofreviseddocument修订后执行日期螃December2007袂Previoustitles/otherreferences蒀原文件名/其它索引号羅ThisdocumentreplacesdocumentPA/PH/OMCL(07)work/WORKGUIDELINE螄“QUALIFICATIONOFEQUIPMENT”肁OMCL网络指南“仪器确认”附件3葿QUALIFICATIONOFUV-VISIBLESPECTROPHOTOMETERS莇紫外-可见光分光光度仪的确认膂Introduction螀ThepresentdocumentisthethirdAnnexofthecoredocument“QualificationofEquipment”,binationwithitwhenplanning,performinganddocumentingtheUV-“仪器的确认”的第三个附件,在计划、实施和记录紫外-可见光分光光度计的确认时应与该核心文件结合使用。薄ThecoredocumentcontainstheIntroductionandgeneralformsforLevelIandIIofqualification,,它们适用于所有类型的仪器。蕿ForUV-Visiblespectrometers,anexamplehasbeenaddedtogiveinstrument-binationwiththegeneralrequirementspresentedinthecoredocument“QualificationofEquipment”,-可见光分光光度计,增加了一个例表给出仪器相关的方案,可以在规划第一级检查清单时,与核心文件里的通用要求“仪器的确认”结合使用。羄Thepresentannexcontainsinstrument-eptancelimits,,其中有第三级和第四级需要检查的参数和对应的典型可接受限度,以及一些可以实施这些检查项目的实践举例。-list(non-exhaustive)检查清单举例(非完全清单)肃Manufacturer:生产商莀Provider/Distributor:供应商/分销商蝿Nameofinstrumentandtype:仪器名称和型号螆Attribute特性薁(thislistmaybeadaptedifnecessary)腿(必要时可以采用本清单)衿Specifications标准袃Benefits芃益处袈(instrument/羈suppliers)芄(仪器/供应商)蚁Assessment羁评价蚀Pass膈通过肆Fails袁不通过葿Spectrophotometer光度计芈Singlebeamanddoublebeammodel单光束和双光束模式蒇Allowbothmodes薂允许双模式蒂芈薃莄Wavelen
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