S.R. CEN/TS 16800:2015
Withdrawn
View Superseded by
GUIDELINE FOR THE VALIDATION OF PHYSICO-CHEMICAL ANALYTICAL METHODS
Hardcopy , PDF
English
01-01-2015
05-13-2021
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Withdrawn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 |
| PD CEN/TS 16800:2015 | Equivalent |
| 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 |