• S.R. CEN/TS 16800:2015

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    GUIDELINE FOR THE VALIDATION OF PHYSICO-CHEMICAL ANALYTICAL METHODS

    Available format(s):  Hardcopy, PDF

    Withdrawn date:  13-05-2021

    Language(s):  English

    Published date:  01-01-2015

    Publisher:  National Standards Authority of Ireland

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

    National Foreword
    European foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Concept
    5 Documentation of the validation process
    6 Validation 1 (V1): Intra-Laboratory Validation
    7 Validation 2 (V2): Inter-Laboratory Validation
    Annex A (normative) - Module A: Test method definition,
            documentation and general requirements
    Annex B (normative) - Module B: Applicability domain and
            pre-validation
    Annex C (normative) - Module C: Intra-laboratory
            performance
    Annex D (normative) - Module D: Requirements for an
            inter-laboratory validation study
    Annex E (informative) - Structure and content of the
            documentation for a validation study (V2)
    Annex F (informative) - Robustness testing by systematic
            variation of influencing factors
    Bibliography

    Abstract - (Show below) - (Hide below)

    Explains an approach for the validation of physico-chemical analytical methods for environmental matrices.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Withdrawn
    Superseded By

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

    ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
    ISO 5725-1:1994 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
    ISO 690:2010 Information and documentation Guidelines for bibliographic references and citations to information resources
    NEN 7777 : 2011 + C1 2012 ENVIRONMENT AND FOOD - PERFORMANCE CHARACTERISTICS OF MEASUREMENT METHODS
    ISO/TS 20612:2007 Water quality Interlaboratory comparisons for proficiency testing of analytical chemistry laboratories
    NFT 90 210 : 2009 WATER QUALITY - PROTOCOL FOR THE INITIAL METHOD PERFORMANCE ASSESSMENT IN A LABORATORY
    ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparison
    ISO 11352:2012 Water quality — Estimation of measurement uncertainty based on validation and quality control data
    ISO/TS 13530:2009 Water quality — Guidance on analytical quality control for chemical and physicochemical water analysis
    EN ISO/IEC 17043:2010 Conformity assessment - General requirements for proficiency testing (ISO/IEC 17043:2010)
    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 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/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
    ISO 3534-2:2006 Statistics Vocabulary and symbols Part 2: Applied statistics
    ISO/IEC 17043:2010 Conformity assessment — General requirements for proficiency testing
    ISO Guide 30:2015 Reference materials Selected terms and definitions
    ISO 8466-2:2001 Water quality — Calibration and evaluation of analytical methods and estimation of performance characteristics — Part 2: Calibration strategy for non-linear second-order calibration functions
    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 5725:1986 Precision of test methods Determination of repeatability and reproducibility for a standard test method by inter-laboratory tests
    ISO 8466-1:1990 Water quality Calibration and evaluation of analytical methods and estimation of performance characteristics Part 1: Statistical evaluation of the linear calibration function
    ISO 9000:2015 Quality management systems — Fundamentals and vocabulary
    ISO 21748:2017 Guidance for the use of repeatability, reproducibility and trueness estimates in measurement uncertainty evaluation
    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
    EN ISO 9000:2015 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015)
    ISO/IEC Guide 98-3:2008 Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995)
    ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability
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