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  • CLSI EP5 A2 : 2ED 2004

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS

    Available format(s): 

    Superseded date:  17-09-2014

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Clinical Laboratory Standards Institute

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    Abstract - (Show below) - (Hide below)

    Specifies guidance for an experiment to evaluate the precision performance of clinical chemistry devices; recommendations for comparing the resulting precision estimates with manfacturer's precision performance claims and determining when such comparisons are valid; as well as manufacturer's guidelines for establishing claims.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersedes NCCLS EP5 A (09/2004)
    Document Type Miscellaneous Product
    Publisher Clinical Laboratory Standards Institute
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    CLSI EP32 R : 1ED 2006 METROLOGICAL TRACEABILITY AND ITS IMPLEMENTATION
    CLSI H56 A : 1ED 2006 BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION
    CLSI GP37 P : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CSA ISO 15197 : 2015 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    CLSI MM7 A2 : 2ED 2013 FLUORESCENCE IN SITU HYBRIDIZATION METHODS FOR CLINICAL LABORATORIES
    CLSI EP18 A2 : 2ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    CLSI EP26 A : 1ED 2013 USER EVALUATION OF BETWEEN-REAGENT LOT VARIATION
    CLSI EP25 A : 1ED 2009 EVALUATION OF STABILITY OF IN VITRO DIAGNOSTIC REAGENTS
    CLSI MM3 P2 : 2ED 2005 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    CLSI EP22 P : 1ED 2010 PRESENTATION OF A MANUFACTURER'S RISK MITIGATION INFORMATION FOR USERS OF IN VITRO DIAGNOSTIC DEVICES
    CLSI C58 A : 1ED 2011 ASSESSMENT OF FETAL LUNG MATURITY BY THE LAMELLAR BODY COUNT
    BS ISO 17593:2007 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    CLSI EP27 A : 1ED 2012 HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR QUANTITATIVE DIAGNOSTIC ASSAYS
    CLSI EP29 A : 1ED 2012 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    CLSI H60 A : 1ED 2014 LABORATORY TESTING FOR THE LUPUS ANTICOAGULANT
    CLSI POCT9 A : 1ED 2010 SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
    CLSI MM1 A3 : 3ED 2012 MOLECULAR METHODS FOR CLINICAL GENETICS AND ONCOLOGY TESTING
    ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    CLSI I/LA28 A2 : 2ED 2011 QUALITY ASSURANCE FOR DESIGN CONTROL AND IMPLEMENTATION OF IMMUNOHISTOCHEMISTRY ASSAYS
    CLSI EP18 P3 : 3ED 2009 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    CLSI MM17 P : 1ED 2007 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    CLSI EP7 A2 : 2ED 2005 INTERFERENCE TESTING IN CLINICAL CHEMISTRY
    CLSI H26 P2 : 2ED 2009 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
    CLSI EP27 P : 1ED 2009 HOW TO CONSTRUCT AND INTERPRET AN ERROR GRID FOR DIAGNOSTIC ASSAYS
    CLSI H57 A : 1ED 2008 PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
    CLSI MM10 A : 1ED 2006 GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
    CLSI C52 A2 : 2ED 2007 TOXICOLOGY AND DRUG TESTING IN THE CLINICAL LABORATORY
    PD ISO/TS 17822-1:2014 In vitro diagnostic test systems. Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens General requirements, terms and definitions
    BS EN ISO 15193:2009 In vitro diagnostic medical devices. Measurement of quantities in samples of biological origin. Requirements for content and presentation of reference measurement procedures
    CLSI EP17 A2 : 2ED 2012 EVALUATION OF DETECTION CAPABILITY FOR CLINICAL LABORATORY MEASUREMENT PROCEDURES
    ISO/TS 17822-1:2014 In vitro diagnostic test systems Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens Part 1: General requirements, terms and definitions
    UNE-EN ISO 18113-1:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    I.S. EN ISO 15193:2009 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
    CLSI GP34 P : 1ED 2009 VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION
    CLSI MM5 A2 : 2ED 2012 NUCLEIC ACID AMPLIFICATION ASSAYS FOR MOLECULAR HEMATOPATHOLOGY
    CLSI POCT9 P : 1ED 2009 SELECTION CRITERIA FOR POINT-OF-CARE TESTING DEVICES
    CLSI EP30 A : 1ED 2010 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    CLSI MM6 A2 : 2ED 2010 QUANTITATIVE MOLECULAR METHODS FOR INFECTIOUS DISEASES
    CLSI EP15 A2 : 2ED 2006 USER VERIFICATION OF PERFORMANCE FOR PRECISION AND TRUENESS
    CLSI NBS04 A : 1ED 2010 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
    CLSI C51 P : 1ED 2010 EXPRESSION OF MEASUREMENT UNCERTAINTY IN LABORATORY MEDICINE
    CLSI C34 A3 : 3ED 2009 SWEAT TESTING: SAMPLE COLLECTION AND QUANTITATIVE CHLORIDE ANALYSIS
    CLSI MM17 A : 1ED 2008 VERIFICATION AND VALIDATION OF MULTIPLEX NUCLEIC ACID ASSAYS
    BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
    EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements (ISO 18113-1:2009)
    CLSI H20 A2 : 2ED 2007 Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods, 2nd Edition
    CLSI H26 A2 : 2ED 2010 VALIDATION, VERIFICATION, AND QUALITY ASSURANCE OF AUTOMATED HEMATOLOGY ANALYZERS
    CLSI MM19 P : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    CLSI EP31 A : 1ED 2008 VERIFICATION OF COMPARABILITY OF PATIENT RESULTS WITHIN ONE HEALTH CARE SYSTEM
    CLSI NBS05 A : 1ED 2011 NEWBORN SCREENING FOR CYSTIC FIBROSIS
    CLSI C24 A3 : 3ED 2006 STATISTICAL QUALITY CONTROL FOR QUANTITATIVE MEASUREMENT PROCEDURES: PRINCIPLES AND DEFINITIONS
    CLSI H59 P : 1ED 2010 QUANTITATIVE D-DIMER FOR THE EXCLUSION OF VENOUS THROMBOEMBOLIC DISEASE
    CLSI MM10 P : 1ED 2005 GENOTYPING FOR INFECTIOUS DISEASES: IDENTIFICATION AND CHARACTERIZATION
    CLSI MM22 A : 1ED 2014 MICROARRAYS FOR DIAGNOSIS AND MONITORING OF INFECTIOUS DISEASES
    CLSI H47 A2 : 2ED 2008 ONE-STAGE PROTHROMBIN TIME (PT) TEST AND ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) TEST
    CLSI I/LA32 P : 1ED 2009 NEWBORN SCREENING BY TANDEM MASS SPECTROMETRY
    CLSI H57 P : 1ED 2007 PROTOCOL FOR THE EVALUATION, VALIDATION, AND IMPLEMENTATION OF COAGULOMETERS
    CLSI C50 P : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
    CLSI MM20 A : 1ED 2012 QUALITY MANAGEMENT FOR MOLECULAR GENETIC TESTING
    CLSI MM3 A2 : 2ED 2006 MOLECULAR DIAGNOSTIC METHODS FOR INFECTIOUS DISEASES
    11/30208525 DC : 0 BS EN ISO 15197 - IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    I.S. EN ISO 18113-1:2011 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    DIN EN ISO 15193:2009-10 IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES
    CLSI C53 P : 1ED 2008 CHARACTERIZATION AND QUALIFICATION OF COMMUTABLE REFERENCE MATERIALS FOR LABORATORY MEDICINE
    CLSI MM19 A : 1ED 2011 ESTABLISHING MOLECULAR TESTING IN CLINICAL LABORATORY ENVIRONMENTS
    ISO 15193:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for content and presentation of reference measurement procedures
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    EN ISO 15193:2009 In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for content and presentation of reference measurement procedures (ISO 15193:2009)
    EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
    CLSI QMS01 A4 : 4ED 2011 QUALITY MANAGEMENT SYSTEM: A MODEL FOR LABORATORY SERVICES
    CLSI EP18 P2 : 2ED 2007 RISK MANAGEMENT TECHNIQUES TO IDENTIFY AND CONTROL LABORATORY ERROR SOURCES
    CLSI GP34 A : 1ED 2010 VALIDATION AND VERIFICATION OF TUBES FOR VENOUS AND CAPILLARY BLOOD SPECIMEN COLLECTION
    CLSI GP16-A3 : 2009 Urinalysis; Approved Guideline—Third Edition
    CLSI H56 P : 1ED 2005 BODY FLUID ANALYSIS FOR CELLULAR COMPOSITION
    CLSI QMS13 A : 1ED 2011 QUALITY MANAGEMENT SYSTEM: EQUIPMENT
    CLSI H59 A : 1ED 2011 QUANTITATIVE D-DIMER FOR THE EXCLUSION OF VENOUS THROMBOEMBOLIC DISEASE
    CLSI I/LA20 A2 : 2ED 2009 ANALYTICAL PERFORMANCE CHARACTERISTICS AND CLINICAL UTILITY OF IMMUNOLOGICAL ASSAYS FOR HUMAN IMMUNOGLOBULIN E (IGE) ANTIBODIES AND DEFINED ALLERGEN SPECIFICITIES
    CLSI C40 A2 : 2ED 2013 MEASUREMENT PROCEDURES FOR THE DETERMINATION OF LEAD CONCENTRATIONS IN BLOOD AND URINE
    CLSI EP9 A3 : 3ED 2013 MEASUREMENT PROCEDURE COMPARISON AND BIAS ESTIMATION USING PATIENT SAMPLES
    CLSI MM16 A : 1ED 2006 USE OF EXTERNAL RNA CONTROLS IN GENE EXPRESSION ASSAYS
    DIN EN ISO 18113-1:2013-01 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS (ISO 18113-1:2009)
    BS EN ISO 18113-1:2011 In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements
    CLSI C50 A : 1ED 2007 MASS SPECTROMETRY IN THE CLINICAL LABORATORY: GENERAL PRINCIPLES AND GUIDANCE
    CLSI GP31 A : 1ED 2009 LABORATORY INSTRUMENT IMPLEMENTATION, VERIFICATION, AND MAINTENANCE
    CLSI C43 A2 : 2ED 2010 GAS CHROMATOGRAPHY/MASS SPECTROMETRY CONFIRMATION OF DRUGS
    UNI EN ISO 18113-1 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
    PREN ISO 15197 : DRAFT 2011 IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS
    UNE-EN ISO 15197:2015 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197:2013)
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