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CEN/TS 16800:2015

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

GUIDELINE FOR THE VALIDATION OF PHYSICO-CHEMICAL ANALYTICAL METHODS
Superseded date

12-01-2021

Published date

19-01-2016

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

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

Committee
TC 230
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

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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