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  • ISO 15194:2009

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    In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  English, French, Russian

    Published date:  04-28-2009

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 15194:2009 specifies requirements for certified reference materials and the content of their supporting documentation, in order for them to be considered of higher metrological order in accordance with ISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards, secondary measurement standards and international conventional calibrators that function either as calibrators or trueness control materials. ISO 15194:2009 also provides requirements on how to collect data for value determination and how to present the assigned value and its measurement uncertainty.

    ISO 15194:2009 applies to certified reference materials with assigned values of differential or rational quantities. Annex A provides information on nominal properties and ordinal quantities.

    ISO 15194:2009 does not apply to reference materials that are parts of an in vitro diagnostic measuring system, although it is possible that many elements are helpful.

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

    Development Note Supersedes ISO/DIS 15194. (04/2009)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

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

    BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    BIS IS/ISO 15189 : 2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    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
    ISO 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
    I.S. EN ISO 15189:2012 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE (ISO 15189:2012, CORRECTED VERSION 2014-08-15)
    I.S. EN ISO 15195:2003 LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES
    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
    ISO 17593:2007 Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
    I.S. EN ISO 17034:2016 GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS (ISO 17034:2016)
    UNI CEN/TS 15968 : 2010 Determination of extractable perfluoro octane sulfonate (PFOS) in solid, coated and impregnated articles, in liquids and fire-fighting foams - Method for sampling, extraction and analysis by means of LC-qMS or LC-MS
    BS EN ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
    PREN ISO 15189 : DRAFT 2011 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    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)
    BS ISO 15198:2004 Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
    UNE-EN ISO 17034:2017 General requirements for the competence of reference material producers (ISO 17034:2016)
    11/30173018 DC : 0 BS EN ISO 15189 - MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    09/30205176 DC : 0 ISO/TS 25680 - MEDICAL LABORATORIES - CALCULATION AND EXPRESSION OF MEASUREMENT UNCERTAINTY
    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)
    BS EN ISO 15195:2003 Laboratory medicine. Requirements for reference measurement laboratories
    ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories
    DIN EN ISO 15189:2014-11 Medical laboratories - Requirements for quality and competence (ISO 15189:2012, Corrected version 2014-08-15)
    UNI EN ISO 15189 : 2013 MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE
    UNI 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
    NF EN ISO 15195 : 2004 LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES
    PD CEN/TS 15968:2010 Determination of extractable perfluorooctanesulphonate (PFOS) in coated and impregnated solid articles, liquids and fire fighting foams. Method for sampling, extraction and analysis by LCqMS or LC-tandem/MS
    NF 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 15198:2004 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
    CEI UNI EN ISO 17034 : 1ED 2018 GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS
    CSA Z15189 : 2003 MEDICAL LABORATORIES - PARTICULAR REQUIREMENTS FOR QUALITY AND COMPETENCE
    BS ISO 17034 : 2016 GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS
    S.R. CEN/TS 15968:2010 DETERMINATION OF EXTRACTABLE PERFLUOROOCTANESULPHONATE (PFOS) IN COATED AND IMPREGNATED SOLID ARTICLES, LIQUIDS AND FIRE FIGHTING FOAMS - METHOD FOR SAMPLING, EXTRACTION AND ANALYSIS BY LC-QMS OR LC-TANDEM/MS
    ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories
    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
    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 15189:2012 Medical laboratories — Requirements for quality and competence
    ISO 18113-1:2009 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions and general requirements
    BS EN ISO 15189:2012 Medical laboratories. Requirements for quality and competence
    ISO 17034:2016 General requirements for the competence of reference material producers
    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 17034:2016 General requirements for the competence of reference material producers (ISO 17034:2016)
    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)
    BS EN ISO 17034:2016 General requirements for the competence of reference material producers
    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)
    15/30327269 DC : 0 BS EN ISO 17034 - GENERAL REQUIREMENTS FOR THE COMPETENCE OF REFERENCE MATERIAL PRODUCERS
    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
    BS 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)
    PD ISO GUIDE 33:2015 Reference materials. Good practice in using reference materials
    ANSI/AAMI/ISO 16142-2:2017 MEDICAL DEVICES - RECOGNIZED ESSENTIAL PRINCIPLES OF SAFETY AND PERFORMANCE OF MEDICAL DEVICES - PART 2: GENERAL ESSENTIAL PRINCIPLES AND ADDITIONAL SPECIFIC ESSENTIAL PRINCIPLES FOR ALL IVD MEDICAL DEVICES AND GUIDANCE ON THE SELECTION OF STANDARDS
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    UNI EN ISO 18113-1 : 2012 IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS
    EN ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003)
    CEN/TS 15968:2010 Determination of extractable perfluorooctanesulphonate (PFOS) in coated and impregnated solid articles, liquids and fire fighting foams - Method for sampling, extraction and analysis by LC-qMS or LC-tandem/MS
    DIN EN ISO 15195:2004-01 LABORATORY MEDICINE - REQUIREMENTS FOR REFERENCE MEASUREMENT LABORATORIES

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
    ISO 15195:2003 Laboratory medicine Requirements for reference measurement laboratories
    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 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    ISO Guide 35:2017 Reference materials Guidance for characterization and assessment of homogeneity and stability
    ISO 18153:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values for catalytic concentration of enzymes assigned calibrators and control materials
    ISO/IEC Guide 63:2012 Guide to the development and inclusion of safety aspects in International Standards for medical devices
    ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO/IEC Guide 15:1977 ISO/IEC code of principles on "reference to standards"
    ISO/IEC Guide 51:2014 Safety aspects Guidelines for their inclusion in standards
    ISO 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO Guide 31:2015 Reference materials Contents of certificates, labels and accompanying documentation
    EN 980:2008 Symbols for use in the labelling of medical devices
    ISO Guide 34:2009 General requirements for the competence of reference material producers
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
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