workoftheCouncilofEuropeQUALITYASSURANCEDOCUMENT质量保证文件PA/PH/OMCL(07)12DEFCORRQUALIFICATIONOFEQUIPMENT仪器确认ANNEX4:QUALIFICATIONOFIRSPECTROPHOTOMETERS附件4红外分光光度计的确认Fulldocumenttitleandreference文件全名和索引号QualificationofEquipment仪器确认Annex4:QualificationofIRsepctrophotometers附件4:红外分光光度计确认PA/PH/OMCL(07)mendationdocumenttobeusedinthecontextofQualityManagementSystemauditsofOMCLsDateoffirstadoption首次采用日期May2007Dateoforiginalentryintoforce首次生效日期July2007Dateofentryintoforceofreviseddocument修订生效日期December2007Previoustitles/otherreferences曾用文件名/其它索引号ThisdocumentreplacesdocumentPA/PH/OMCL(07)work/WORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”OMCL网络指南“仪器确认”附件4QUALIFICATIONOFIRSPECTROPHOTOMETERS红外分光光度计的确认Introduction介绍ThepresentdocumentisthefourthAnnexofthecoredocument“QualificationofEquipment”,binationwithitwhenplanning,“仪器确认”核心文件的第四个附件,在对红外分光光度计确认过程进行计划、实施和记录时,应结合该核心文件一起使用。ThecoredocumentcontainstheIntroductionandgeneralformsforLevelIandIIofqualification,,该表格通用于各类型仪器。ForFTIRspectrometers,anexamplehasbeenaddedtogiveinstrument-binationwiththegeneralrequirementspresentedinthecoredocument“QualificationofEquipment”,,在本指南中给出一个仪器专用的方案,在起草第一级检查清单时,与“仪器确认”核心文件中的第一级通用表格一起使用。Thepresentannexcontainsinstrument-eptancelimits,,在第三级和第四级确认中需要检查的参数,以及其相应的典型可接受限度,和用于实施这些检查的实用方法举例。-list(non-exhaustive)检查清单举例(未尽列举)Manufacturer:生产商Provider/Distributor:分销商/供货商Nameofinstrumentandtype:仪器名称和型号Attribute特征(Thislistmaybeadaptedifnecessary)(本清单在需要时采用)Specification标准Benefits优点(Instrument/supplier)(仪器/供应商)Assessment评价Pass通过Fails不通过Spectrophotometer分光光度计Detectorrange检测器范围TheopticalbenchshallincludeaDTGSdetectorwithafrequencyrangeof7400to350cm-1光具座应包括一个DTGS检测器,其频率范围为7400至350cm-ewithanair-cooledstandardinfr
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