BS EN ISO 18153-2003 体外诊疗装置.生物样品的定量测量.校准仪和控制系统指定酶的催化浓度的测量溯源性
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【英文标准名称】:Invitrodiagnosticmedicaldevices-Measurementofquantitiesinbiologicalsamples-Metrologicaltraceabilityofvaluesforcatalyticconcentrationofenzymesassignedtocalibratorsandcontrolmaterials
【原文标准名称】:体外诊疗装置.生物样品的定量测量.校准仪和控制系统指定酶的催化浓度的测量溯源性
【标准号】:BSENISO18153-2003
【标准状态】:现行
【国别】:英国
【发布日期】:2003-08-19
【实施或试行日期】:2003-08-19
【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】:测量技术;试样;基准方法;检查材料;在实验室条件下;测量;实验室条件下诊断;系统论;化学分析和试验;计量学;规范(验收);测量精度;校准仪;特性记述;磨损量;测量系统;分类;描述;评定;标准参考测量方法;催化剂;参考材料;人用的药物;浓缩值;诊断;实验室;生物化学制品;表;实验室医学;诊断设备;分类系统;酶;诊断(医学);定义;尺寸;特性;再循环;医学科学
【英文主题词】:Biochemicals;Calibrator;Catalysts;Characterisations;Characteristics;Checkmaterial;Chemicalanalysisandtesting;Classification;Classificationsystems;Concentrationvalues;Definition;Definitions;Descriptions;Diagnosis;Diagnosis(medical);Diagnosticequipment;Enzymes;Evaluations;Humanmedicine;Invitro;In-vitrodiagnostic;Laboratories;Laboratorymedicine;Lists;Measurement;Measuringaccuracy;Measuringsystems;Measuringtechniques;Medicalsciences;Metrology;Recirculation;Referencematerials;Referencemeasuringmethods;Referencemethods;Samples;Size;Specification(approval);Systemology;Wear-quantity
【摘要】:ISO18153:2003specifieshowtoassurethemetrologicaltraceabilityofvaluesassignedtocalibratorsandcontrolmaterialsintendedtoestablishorverifytruenessofmeasurementofthecatalyticconcentrationofenzymes.Thecalibratorsandcontrolmaterialsarethoseprovidedbythemanufacturersaspartof,ortobeusedtogetherwith,invitrodiagnosticmedicaldevices.ThefollowingsubjectsareoutsidethescopeofISO18153:2003:requirementsforthedesignorselectionofareferencemeasurementprocedure;quantitiesinvolvingmassofenzymeorimmunoreactivityofenzymes;controlmaterialsthatdonothaveanassignedvalueandareusedonlyforassessingtheprecisionofameasurementprocedure,eitheritsrepeatabilityorreproducibility(precisioncontrolmaterials);controlmaterialsintendedforintralaboratoryqualitycontrolpurposesandsuppliedwithintervalsofsuggestedacceptablevalues,eachintervalobtainedbyinterlaboratoryconsensuswithrespecttoonespecifiedmeasurementprocedure,andwithlimitingvaluesthatarenotmetrologicallytraceable;metrologicaltraceabilityofroutineresultstotheproductcalibratorandtheirrelationstoanymedicaldiscriminationlimit;propertiesinvolvingnominalandordinalscales.
【中国标准分类号】:C39
【国际标准分类号】:07_100_10
【页数】:20P.;A4
【正文语种】:英语
【原文标准名称】:体外诊疗装置.生物样品的定量测量.校准仪和控制系统指定酶的催化浓度的测量溯源性
【标准号】:BSENISO18153-2003
【标准状态】:现行
【国别】:英国
【发布日期】:2003-08-19
【实施或试行日期】:2003-08-19
【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】:测量技术;试样;基准方法;检查材料;在实验室条件下;测量;实验室条件下诊断;系统论;化学分析和试验;计量学;规范(验收);测量精度;校准仪;特性记述;磨损量;测量系统;分类;描述;评定;标准参考测量方法;催化剂;参考材料;人用的药物;浓缩值;诊断;实验室;生物化学制品;表;实验室医学;诊断设备;分类系统;酶;诊断(医学);定义;尺寸;特性;再循环;医学科学
【英文主题词】:Biochemicals;Calibrator;Catalysts;Characterisations;Characteristics;Checkmaterial;Chemicalanalysisandtesting;Classification;Classificationsystems;Concentrationvalues;Definition;Definitions;Descriptions;Diagnosis;Diagnosis(medical);Diagnosticequipment;Enzymes;Evaluations;Humanmedicine;Invitro;In-vitrodiagnostic;Laboratories;Laboratorymedicine;Lists;Measurement;Measuringaccuracy;Measuringsystems;Measuringtechniques;Medicalsciences;Metrology;Recirculation;Referencematerials;Referencemeasuringmethods;Referencemethods;Samples;Size;Specification(approval);Systemology;Wear-quantity
【摘要】:ISO18153:2003specifieshowtoassurethemetrologicaltraceabilityofvaluesassignedtocalibratorsandcontrolmaterialsintendedtoestablishorverifytruenessofmeasurementofthecatalyticconcentrationofenzymes.Thecalibratorsandcontrolmaterialsarethoseprovidedbythemanufacturersaspartof,ortobeusedtogetherwith,invitrodiagnosticmedicaldevices.ThefollowingsubjectsareoutsidethescopeofISO18153:2003:requirementsforthedesignorselectionofareferencemeasurementprocedure;quantitiesinvolvingmassofenzymeorimmunoreactivityofenzymes;controlmaterialsthatdonothaveanassignedvalueandareusedonlyforassessingtheprecisionofameasurementprocedure,eitheritsrepeatabilityorreproducibility(precisioncontrolmaterials);controlmaterialsintendedforintralaboratoryqualitycontrolpurposesandsuppliedwithintervalsofsuggestedacceptablevalues,eachintervalobtainedbyinterlaboratoryconsensuswithrespecttoonespecifiedmeasurementprocedure,andwithlimitingvaluesthatarenotmetrologicallytraceable;metrologicaltraceabilityofroutineresultstotheproductcalibratorandtheirrelationstoanymedicaldiscriminationlimit;propertiesinvolvingnominalandordinalscales.
【中国标准分类号】:C39
【国际标准分类号】:07_100_10
【页数】:20P.;A4
【正文语种】:英语
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