UNI CEN/TR 10345 : 2008
Current
The latest, up-to-date edition.
Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
04-12-2008
Foreword
1 Scope
2 Normative references
3 Principle
4 Preliminary rules
4.1 First rule ('to be clear')
4.2 Second rule ('to be modest')
4.3 Minimal characteristics of data population
5 Procedure
5.1 Bases
5.2 Raw data examination
5.3 Intra laboratory repeatability variance
(Cochran's test)
5.4 Intra laboratory reproducibility variance
(Grubbs' test)
5.5 Inter laboratory reproducibility variance
(Grubbs' test)
5.6 Retained data examination
5.7 Calculation of the variances associated to
the tested method
5.8 Treatment for unexpected calculated variances
5.9 Estimation of a function linking variance and
level
6 Report
7 General remarks
Annex A - Steps for the validation of a Draft Standard
Annex B - Synoptic of the operations described in Annex A
Annex C - Examples
Bibliography
Provides guidelines to carry out the statistical evaluation of data from an inter laboratory test for method validation.
| Committee |
CT 700
|
| DocumentType |
Technical Report
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Current
|
| Standards | Relationship |
| CEN/TR 10345:2013 | Identical |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| 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 5725-2:1994 | 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 |
| NFX 06 050 : 1995 | APPLICATION OF STATISTICS - STUDY OF THE NORMALITY OF A DISTRIBUTION |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |
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