BS EN ISO 15194-2009 体外诊断医疗器械.生物源样品的数量测量.辅助文档的认证参考材料和内容要求
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【英文标准名称】:Invitrodiagnosticmedicaldevices-Measurementofquantitiesinsamplesofbiologicalorigin-Requirementsforcertifiedreferencematerialsandthecontentofsupportingdocumentation
【原文标准名称】:体外诊断医疗器械.生物源样品的数量测量.辅助文档的认证参考材料和内容要求
【标准号】:BSENISO15194-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-05-31
【实施或试行日期】:2009-05-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物化学制品;校准材料;合格证书;特性记述;特性;检查材料;化学分析和试验;分类;分类系统;通用名;定义;描述;诊断;评估;人用的药物;在体外;使用说明书;体外诊断;实验室;实验室医学;表;模型;被测量值;测量;测量系统;测量技术;医学科学;计量学;数值;参数;参考材料;标准参考测量方法;基准方法;试样;尺寸规格;大小测量;规范(验收);系统论;术语;证实;磨损量
【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】:26P.;A4
【正文语种】:英语
【原文标准名称】:体外诊断医疗器械.生物源样品的数量测量.辅助文档的认证参考材料和内容要求
【标准号】:BSENISO15194-2009
【标准状态】:现行
【国别】:英国
【发布日期】:2009-05-31
【实施或试行日期】:2009-05-31
【发布单位】:英国标准学会(GB-BSI)
【起草单位】:BSI
【标准类型】:()
【标准水平】:()
【中文主题词】:生物化学制品;校准材料;合格证书;特性记述;特性;检查材料;化学分析和试验;分类;分类系统;通用名;定义;描述;诊断;评估;人用的药物;在体外;使用说明书;体外诊断;实验室;实验室医学;表;模型;被测量值;测量;测量系统;测量技术;医学科学;计量学;数值;参数;参考材料;标准参考测量方法;基准方法;试样;尺寸规格;大小测量;规范(验收);系统论;术语;证实;磨损量
【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】:26P.;A4
【正文语种】:英语
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