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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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GUIDELINE FOR THE VALIDATION OF PHYSICO-CHEMICAL ANALYTICAL METHODS
Hardcopy , PDF
13-05-2021
English
01-01-2015
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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
Explains an approach for the validation of physico-chemical analytical methods for environmental matrices.
| DocumentType |
Standard
|
| Pages |
52
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| CEN/TS 16800:2015 | Identical |
| 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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