Skip to content
Please enter a keyword to search
  • Preview

    I.S. EN ISO 15193:2009

    Current The latest, up-to-date edition.

    IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN SAMPLES OF BIOLOGICAL ORIGIN - REQUIREMENTS FOR CONTENT AND PRESENTATION OF REFERENCE MEASUREMENT PROCEDURES

    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.

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Presentation of a reference measurement procedure
      4.1 Elements of a reference measurement
           procedure
      4.2 Warning and safety precautions
      4.3 Introduction
      4.4 Scope
      4.5 Terms, definitions, symbols and abbreviated
           terms
      4.6 Measurement principle and measurement
           method
      4.7 Check list
      4.8 Reagents and materials
      4.9 Apparatus
      4.10 Sampling and sample
      4.11 Preparation of measuring system and
           analytical portion
      4.12 Operation of measuring system
      4.13 Data processing
      4.14 Analytical reliability
      4.15 Special cases
      4.16 Validation of a reference measurement
           procedure
      4.17 Reporting
      4.18 Quality assurance
      4.19 Bibliography
      4.20 Dates of authorization and revision
    Annex A (informative) - Reference procedures for
            properties other than differential and rational
            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 the content of a reference measurement procedure for in vitro diagnostic medical devices and medical laboratories.

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

    Development Note Supersedes I.S. EN 12286. (09/2009)
    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Current

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

    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    ISO Guide 32:1997 Calibration in analytical chemistry and use of certified reference materials
    ISO 15194:2009 In vitro diagnostic medical devices Measurement of quantities in samples of biological origin Requirements for certified reference materials and the content of supporting documentation
    ISO 4791-1:1985 Laboratory apparatus — Vocabulary relating to apparatus made essentially from glass, porcelain or vitreous silica — Part 1: Names for items of apparatus
    CLSI EP5 A2 : 2ED 2004 EVALUATION OF PRECISION PERFORMANCE OF QUANTITATIVE MEASUREMENT METHODS
    ISO 5725-3:1994 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate measures of the precision of a standard measurement method
    ISO Guide 33:2015 Reference materials Good practice in using reference materials
    ISO 5725-6:1994 Accuracy (trueness and precision) of measurement methods and results — Part 6: Use in practice of accuracy values
    ISO 5725-4:1994 Accuracy (trueness and precision) of measurement methods and results Part 4: Basic methods for the determination of the trueness of a standard measurement method
    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 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 17511:2003 In vitro diagnostic medical devices Measurement of quantities in biological samples Metrological traceability of values assigned to calibrators and control materials
    ISO 6353-3:1987 Reagents for chemical analysis — Part 3: Specifications — Second series
    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
    CLSI EP17 A : 1ED 2004 PROTOCOLS FOR DETERMINATION OF LIMITS OF DETECTION AND LIMITS OF QUANTITATION
    ISO 3696:1987 Water for analytical laboratory use — Specification and test methods
    ISO Guide 34:2009 General requirements for the competence of reference material producers
    ISO 78-2:1999 Chemistry Layouts for standards Part 2: Methods of chemical analysis
    ISO 5725-5:1998 Accuracy (trueness and precision) of measurement methods and results — Part 5: Alternative methods for the determination of the precision of a standard measurement method
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective