ISO 18153-2003 体外诊断医疗装置.生物样品的定量测量.校准仪和控制材料所赋酶的催化浓度值的计量溯源性
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【英文标准名称】:Invitrodiagnosticmedicaldevices-Measurementofquantitiesinbiologicalsamples-Metrologicaltraceabilityofvaluesforcatalyticconcentrationofenzymesassignedcalibratorsandcontrolmaterials
【原文标准名称】:体外诊断医疗装置.生物样品的定量测量.校准仪和控制材料所赋酶的催化浓度值的计量溯源性
【标准号】:ISO18153-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-08
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC212
【标准类型】:()
【标准水平】:()
【中文主题词】:测量精度;特性记述;描述;基准方法;检查材料;实验室条件下诊断;规范(验收);实验室;计量学;评定;表;生物化学制品;实验室医学;系统论;磨损量;分类系统;诊断(医学);诊断;催化剂;参考材料;标准参考测量方法;化学分析和试验;特性;人用的药物;浓缩值;再循环;试样;医学科学;测量系统;测量;测量技术;尺寸;定义;分类;在实验室条件下;诊断设备;校准仪;酶
【英文主题词】:Biochemicals;Calibrator;Catalysts;Characterisations;Characteristics;Checkmaterial;Chemicalanalysisandtesting;Classification;Classificationsystems;Concentrationvalues;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】:ThisEuropeanStandardspecifieshowtoassurethemetrologicaltraceabilityofvaluesassignedtocalibratorsandcontrolmaterialsintendedtoestablishorverifytruenessofmeasurementofthecatalyticconcentrationofenzymes.Thecalibratorsandcontrolmaterialsarethoseprovidedbythemanufacturersaspartof,ortobeusedtogetherwith,invitrodiagnosticmedicaldevices.Thefollowingsubjectsareoutsidethescopeofthisstandard:a)requirementsforthedesignorselectionofareferencemeasurementprocedure;b)quantitiesinvolvingmassofenzymeorimmunoreactivityofenzymes;c)controlmaterialsthatdonothaveanassignedvalueandareusedonlyforassessingtheprecisionofameasurementprocedure,eitheritsrepeatabilityorreproducibility(precisioncontrolmaterials);d)controlmaterialsintendedforintralaboratoryqualitycontrolpurposesandsuppliedwithintervalsofsuggestedacceptablevalues,eachintervalobtainedbyinterlaboratoryconsensuswithrespecttoonespecitiedmeasurementprocedure,andwithlimitingvaluesthatarenotmetrologicallytraceable;e)metrologicaltraceabilityofroutineresultstotheproductcalibratorandtheirrelationstoanymedicaldiscriminationlimit;f)propertiesinvolvingnominalandordinalscales.
【中国标准分类号】:C30
【国际标准分类号】:11_100_10
【页数】:10P;A4
【正文语种】:英语
【原文标准名称】:体外诊断医疗装置.生物样品的定量测量.校准仪和控制材料所赋酶的催化浓度值的计量溯源性
【标准号】:ISO18153-2003
【标准状态】:现行
【国别】:国际
【发布日期】:2003-08
【实施或试行日期】:
【发布单位】:国际标准化组织(IX-ISO)
【起草单位】:ISO/TC212
【标准类型】:()
【标准水平】:()
【中文主题词】:测量精度;特性记述;描述;基准方法;检查材料;实验室条件下诊断;规范(验收);实验室;计量学;评定;表;生物化学制品;实验室医学;系统论;磨损量;分类系统;诊断(医学);诊断;催化剂;参考材料;标准参考测量方法;化学分析和试验;特性;人用的药物;浓缩值;再循环;试样;医学科学;测量系统;测量;测量技术;尺寸;定义;分类;在实验室条件下;诊断设备;校准仪;酶
【英文主题词】:Biochemicals;Calibrator;Catalysts;Characterisations;Characteristics;Checkmaterial;Chemicalanalysisandtesting;Classification;Classificationsystems;Concentrationvalues;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】:ThisEuropeanStandardspecifieshowtoassurethemetrologicaltraceabilityofvaluesassignedtocalibratorsandcontrolmaterialsintendedtoestablishorverifytruenessofmeasurementofthecatalyticconcentrationofenzymes.Thecalibratorsandcontrolmaterialsarethoseprovidedbythemanufacturersaspartof,ortobeusedtogetherwith,invitrodiagnosticmedicaldevices.Thefollowingsubjectsareoutsidethescopeofthisstandard:a)requirementsforthedesignorselectionofareferencemeasurementprocedure;b)quantitiesinvolvingmassofenzymeorimmunoreactivityofenzymes;c)controlmaterialsthatdonothaveanassignedvalueandareusedonlyforassessingtheprecisionofameasurementprocedure,eitheritsrepeatabilityorreproducibility(precisioncontrolmaterials);d)controlmaterialsintendedforintralaboratoryqualitycontrolpurposesandsuppliedwithintervalsofsuggestedacceptablevalues,eachintervalobtainedbyinterlaboratoryconsensuswithrespecttoonespecitiedmeasurementprocedure,andwithlimitingvaluesthatarenotmetrologicallytraceable;e)metrologicaltraceabilityofroutineresultstotheproductcalibratorandtheirrelationstoanymedicaldiscriminationlimit;f)propertiesinvolvingnominalandordinalscales.
【中国标准分类号】:C30
【国际标准分类号】:11_100_10
【页数】:10P;A4
【正文语种】:英语
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