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    I.S. EN ISO 15194:2009

    Current The latest, up-to-date edition.

    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

    Language(s):  English

    Published date:  01-01-2009

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Systematic format of properties in the supporting
      documentation of a certified reference material
      4.1 Format of properties
      4.2 Construction of systematic designations
      4.3 Trivial names
    5 Properties, production, and characterization of a
      certified reference material
      5.1 Hierarchical position
      5.2 Properties
      5.3 Production and characterization
    6 Content of supporting documentation
      6.1 Supporting documentation
      6.2 Label
      6.3 Certificate
      6.4 Certification report
    Annex A (informative) - Certified reference materials
            with nominal properties or ordinal quantities
    Bibliography
    Annex ZA (informative) - Relationship between this
             International Standard and the Essential
             Requirements of EU Directive 98/79

    Abstract - (Show below) - (Hide below)

    Describes 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.

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

    Development Note Supersedes I.S. EN 12287. (09/2009)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

    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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