DIN EN ISO 15194-2009 医用体外诊断装置.生物原始试样中数量值的测量.合格参考材料的要求和支持文件的内容(ISO15194:2009),DINENISO15194:2009-10的英文版本
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【英文标准名称】:Invitrodiagnosticmedicaldevices-Measurementofquantitiesinsamplesofbiologicalorigin-Requirementsforcertifiedreferencematerialsandthecontentofsupportingdocumentation(ISO15194:2009);EnglishversionofDINENISO15194:2009-10
【原文标准名称】:医用体外诊断装置.生物原始试样中数量值的测量.合格参考材料的要求和支持文件的内容(ISO15194:2009),DINENISO15194:2009-10的英文版本
【标准号】:DINENISO15194-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-10
【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】:
【英文主题词】:Biochemicals;Calibrationmaterials;Certificates;Characterisations;Characteristics;Checkmaterial;Chemicalanalysisandtesting;Classification;Classificationsystems;Commonname;Definitions;Descriptions;Diagnosis;Evaluations;Humanmedicine;Invitro;Instructionsforuse;In-vitrodiagnostic;Laboratories;Laboratorymedicine;Lists;Matrices;Measuredvalue;Measurement;Measuringsystems;Measuringtechniques;Medicalsciences;Metrology;Numericalvalues;Parameters;Referencematerials;Referencemeasuringmethods;Referencemethods;Samples;Size;Sizemeasurement;Specification(approval);Systemology;Terminology;Validation;Wear-quantity
【摘要】:ThisInternationalStandardspecifiesrequirementsforcertifiedreferencematerialsandthecontentoftheirsupportingdocumentation,inorderforthemtobeconsideredofhighermetrologicalorderinaccordancewithISO17511.Itisapplicabletocertifiedreferencematerialsclassifiableasprimarymeasurementstandards,secondarymeasurementstandardsandinternationalconventionalcalibratorsthatfunctioneitherascalibratorsortruenesscontrolmaterials.ThisInternationalStandardalsoprovidesrequirementsonhowtocollectdataforvaluedeterminationandhowtopresenttheassignedvalueanditsmeasurementuncertainty.ThisInternationalStandardappliestocertifiedreferencematerialswithassignedvaluesofdifferentialorrationalquantities.AnnexAprovidesinformationonnominalpropertiesandordinalquantities.ThisInternationalStandarddoesnotapplytoreferencematerialsthatarepartsofaninvitrodiagnosticmeasuringsystem,althoughitispossiblethatmanyelementsarehelpful.
【中国标准分类号】:C38
【国际标准分类号】:11_100_10
【页数】:25P.;A4
【正文语种】:英语
【原文标准名称】:医用体外诊断装置.生物原始试样中数量值的测量.合格参考材料的要求和支持文件的内容(ISO15194:2009),DINENISO15194:2009-10的英文版本
【标准号】:DINENISO15194-2009
【标准状态】:现行
【国别】:德国
【发布日期】:2009-10
【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】:
【英文主题词】:Biochemicals;Calibrationmaterials;Certificates;Characterisations;Characteristics;Checkmaterial;Chemicalanalysisandtesting;Classification;Classificationsystems;Commonname;Definitions;Descriptions;Diagnosis;Evaluations;Humanmedicine;Invitro;Instructionsforuse;In-vitrodiagnostic;Laboratories;Laboratorymedicine;Lists;Matrices;Measuredvalue;Measurement;Measuringsystems;Measuringtechniques;Medicalsciences;Metrology;Numericalvalues;Parameters;Referencematerials;Referencemeasuringmethods;Referencemethods;Samples;Size;Sizemeasurement;Specification(approval);Systemology;Terminology;Validation;Wear-quantity
【摘要】:ThisInternationalStandardspecifiesrequirementsforcertifiedreferencematerialsandthecontentoftheirsupportingdocumentation,inorderforthemtobeconsideredofhighermetrologicalorderinaccordancewithISO17511.Itisapplicabletocertifiedreferencematerialsclassifiableasprimarymeasurementstandards,secondarymeasurementstandardsandinternationalconventionalcalibratorsthatfunctioneitherascalibratorsortruenesscontrolmaterials.ThisInternationalStandardalsoprovidesrequirementsonhowtocollectdataforvaluedeterminationandhowtopresenttheassignedvalueanditsmeasurementuncertainty.ThisInternationalStandardappliestocertifiedreferencematerialswithassignedvaluesofdifferentialorrationalquantities.AnnexAprovidesinformationonnominalpropertiesandordinalquantities.ThisInternationalStandarddoesnotapplytoreferencematerialsthatarepartsofaninvitrodiagnosticmeasuringsystem,althoughitispossiblethatmanyelementsarehelpful.
【中国标准分类号】:C38
【国际标准分类号】:11_100_10
【页数】:25P.;A4
【正文语种】:英语
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