Skip to content
Please enter a keyword to search

  • CEN/TS 16800:2015

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    GUIDELINE FOR THE VALIDATION OF PHYSICO-CHEMICAL ANALYTICAL METHODS

    Available format(s): 

    Superseded date:  12-01-2021

    Language(s): 

    Published date:  18-01-2016

    Publisher:  Comite Europeen de Normalisation

    Pure ENs are not available for sale, please purchase a suitable national adoption

    Sorry this product is not available in your region.

    Add To Cart

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

    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)

    Committee TC 230
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    Status Superseded
    Superseded By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
    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