DIN EN ISO 15193-2009 体外诊断医疗设备.生物源样品中数量的测量.参考测量程序的内容和表示要求(ISO15193:2009),DINENISO15193:2009-10的英文版本
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【英文标准名称】:Invitrodiagnosticmedicaldevices-Measurementofquantitiesinsamplesofbiologicalorigin-Requirementsforcontentandpresentationofreferencemeasurementprocedures(ISO15193:2009);EnglishversionofDINENISO15193:2009-10
【原文标准名称】:体外诊断医疗设备.生物源样品中数量的测量.参考测量程序的内容和表示要求(ISO15193:2009),DINENISO15193:2009-10的英文版本
【标准号】:DINENISO15193-2009
【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;Biologicalmaterials;Biology;Characterisations;Characteristics;Chemicalanalysisandtesting;Classification;Classificationsystems;Definitions;Diagnosis;Evaluations;Humanmedicine;Hygiene;Invitro;Infectivematerials;In-vitrodiagnostic;Laboratories;Laboratorymedicine;Lists;Marking;Measurement;Measuringsystems;Measuringtechniques;Medicalsciences;Microbiology;Pathogenicbacteria;Referencematerials;Referencemeasuringmethods;Referencemethods;Representations;Samples;Specification(approval);Specimens;Systemology;Testing;Wear-quantity
【摘要】:ThisInternationalStandardspecifiesrequirementsforthecontentofareferencemeasurementprocedureforinvitrodiagnosticmedicaldevicesandmedicallaboratories.NOTE1ItisintendedthatanexperiencedlaboratoryworkerwhofollowsameasurementprocedurewritteninaccordancewiththisInternationalStandardcanbeexpectedtoproducemeasurementresultswithameasurementuncertaintynotexceedingthestipulatedinterval.ThisInternationalStandardappliestoreferencemeasurementproceduresprovidingvaluesofdifferentialorrationalquantities.AnnexAprovidesinformationonnominalpropertiesandordinalquantities.ThisInternationalStandardisvalidforanyperson,bodyorinstitutioninvolvedinoneofthevariousbranchesoflaboratorymedicinewhoseintentionistowriteadocumenttoserveasareferencemeasurementprocedure.Fulldescriptionsofmeasurementmethodsareusuallypublishedinscientificliterature,inwhichmethodsaredescribedinsufficientdetailthattheycanbeusedasthebasisofadocumentedmeasurementprocedure.NOTE2InthisInternationalStandard,"internationalmeasurementstandard"designatesamaterialstandard.Theterm"internationalstandard"isusedbyWHOforreferencematerials.
【中国标准分类号】:C38
【国际标准分类号】:11_100_10
【页数】:28P.;A4
【正文语种】:英语
【原文标准名称】:体外诊断医疗设备.生物源样品中数量的测量.参考测量程序的内容和表示要求(ISO15193:2009),DINENISO15193:2009-10的英文版本
【标准号】:DINENISO15193-2009
【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;Biologicalmaterials;Biology;Characterisations;Characteristics;Chemicalanalysisandtesting;Classification;Classificationsystems;Definitions;Diagnosis;Evaluations;Humanmedicine;Hygiene;Invitro;Infectivematerials;In-vitrodiagnostic;Laboratories;Laboratorymedicine;Lists;Marking;Measurement;Measuringsystems;Measuringtechniques;Medicalsciences;Microbiology;Pathogenicbacteria;Referencematerials;Referencemeasuringmethods;Referencemethods;Representations;Samples;Specification(approval);Specimens;Systemology;Testing;Wear-quantity
【摘要】:ThisInternationalStandardspecifiesrequirementsforthecontentofareferencemeasurementprocedureforinvitrodiagnosticmedicaldevicesandmedicallaboratories.NOTE1ItisintendedthatanexperiencedlaboratoryworkerwhofollowsameasurementprocedurewritteninaccordancewiththisInternationalStandardcanbeexpectedtoproducemeasurementresultswithameasurementuncertaintynotexceedingthestipulatedinterval.ThisInternationalStandardappliestoreferencemeasurementproceduresprovidingvaluesofdifferentialorrationalquantities.AnnexAprovidesinformationonnominalpropertiesandordinalquantities.ThisInternationalStandardisvalidforanyperson,bodyorinstitutioninvolvedinoneofthevariousbranchesoflaboratorymedicinewhoseintentionistowriteadocumenttoserveasareferencemeasurementprocedure.Fulldescriptionsofmeasurementmethodsareusuallypublishedinscientificliterature,inwhichmethodsaredescribedinsufficientdetailthattheycanbeusedasthebasisofadocumentedmeasurementprocedure.NOTE2InthisInternationalStandard,"internationalmeasurementstandard"designatesamaterialstandard.Theterm"internationalstandard"isusedbyWHOforreferencematerials.
【中国标准分类号】:C38
【国际标准分类号】:11_100_10
【页数】:28P.;A4
【正文语种】:英语
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