仪器确认-附件9-pH计确认-中英文

PA/PH/0MCL(13)863R 欧盟 OMCL 仪器确认附件9:pH 计(中英文)ourPreferredPartnertoComplianceOMCLNetworkoftheCouncilofEuropeQUALITYMANAGEMENTDOCUMENTPA/PH/OMCL(13)863RQUALIFICATIONOFEQUIPMENTANNEX9:CALIBRATION/QUALIFICATIONOFPH-METERSOMCL 质量管理文件PA/PH/OMCL(13)863R仪器验证附件 9：pH 计校正/确认FulldocumenttitleandreferenceQualificationofEquipmentAnnex9:Calibration/QualificationofpHMetersPA/PH/OMCL(13)863R文件全名和索引号设备确认附件 9：pH 计校正/确认PA/PH/OMCL(13)863RDocumenttypeGuidelineLegislativebasisDateoffirstadoption首次采纳日期Dateoforiginalentryintoforce1stNovember2015首次生效日期DateofentryintoforceofreviseddocumePrevioustitles/otherreferences/lastvalidversion旧文件题目/其它索引号/最后有效版本CustodianOrganisationThepresentdocumentwaselaboratedbytheOMCLNetwork/EDQMoftheCouncilofEurope监管机构现行文件由 OMCL 网络/EDQM 起草ConcernedNetworkANNEX9OFTHEOMCLNETWORKGUIDELINE“QUALIFICATIONOFEQUIPMENT”CALIBRATION/QUALIFICATIONOFpHMETERSOMCL 网络指南“仪器验证”之附件 9：pH 计校正/确认1. INTRODUCTION 概述Thisdocumentisthe9thAnnextothecoredocument“QualificationofEquipment”，whichtakentogethershouldbeusedwhenplanning,performinganddocumentingthequalificationprocessofpHmeters.ThecoredocumentcontainstheintroductionandgeneralformsforLevelIandIIofqualification,whicharecommontoalltypesofinstruments.本文件是核心文件“仪器确认”的第 9 个附件。在规划、实施和记录 pH 计的确认过程时应将本文件与核心文件一起使用。核心文件包括第 I 级和第 II 级确认的概述和通用表格，所有类型的仪器都是通用的。Annex9containsinstrument-relatedrecommendationsonparameterstobecheckedatLevelIIIandIVofqualificationandthecorrespondingtypicalacceptancelimits,aswellaspracticalexamplesonthemethodologythatcanbeusedtocarryoutthesechecks.附件 9 包括与仪器相关第 III 级和第 IV 级确认所需检查的参数的建议，以及对应的一般可接受限度，还有可以用来实施这些检查的方法学实际案例。2. AIMANDSCOPEOFTHEGUIDELINE 本指南的目标和范围ThisguidelinedescribestherequirementsforpHmetersusedfordeterminat...