CEN/TR 10345:2008

Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods

This document is a guideline to carry out the statistical evaluation of data from an inter laboratory test for method validation.
Its purpose is to detail the methodology of ISO 5725-1, -2 and -3:1994 standards for the treatment of registered data in the conditions used within the ECISS/TC 20 working groups.
NOTE   The present document is not a simplification of ISO 5725 standard, which is the only reference document.

Richtlinien für statistische Verfahren der Probenahme und Analyse von Eisen, Stahl und anderen Eisenmetallen

Guide pour le traitement statistique des données de validation de méthodes d'analyse, issues d'essais interlaboratoire

Ce document est un guide pour le traitement statistique des données de validation de méthodes, issues
d'essais interlaboratoire.
Son but est de préciser dans le détail la méthodologie des normes ISO 5725-1, -2 et -3:1994 pour le
traitement de données obtenues dans les conditions mises en oeuvre au sein des groupes de travail de
l'ECISS/TC 20.
NOTE Le présent document n'est pas une simplification de la norme ISO 5725, qui est le seul document de
référence.

Smernice za statistične postopke vzorčenja in analize železa, jekla in drugih kovinskih materialov na osnovi železa

General Information

• Status: Withdrawn
• Publication Date: 24-Jun-2008
• Withdrawal Date: 03-Dec-2013
• ICS: 03.120.30 - Application of statistical methods
• ICS: 17.020 - Metrology and measurement in general
• Technical Committee: ECISS/TC 102 - Methods of chemical analysis for iron and steel
• Drafting Committee: ECISS/TC 20 - Methods of chemical analysis of ferrous products
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 04-Dec-2013
• Completion Date: 04-Dec-2013
• Ref Project: SIST-TP CEN/TR 10345:2008 - Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods

Relations

• Replaced By: CEN/TR 10345:2013 - Guideline for statistical data treatment of inter laboratory tests for validation of analytical methods
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST-TP CEN/TR 10345:2008
01-september-2008
6PHUQLFH]DVWDWLVWLþQHSRVWRSNHY]RUþHQMDLQDQDOL]HåHOH]DMHNODLQGUXJLK
NRYLQVNLKPDWHULDORYQDRVQRYLåHOH]D
Guideline for statistical data treatment of inter laboratory tests for validation of analytical
methods
Richtlinien für statistische Verfahren der Probenahme und Analyse von Eisen, Stahl und
anderen Eisenmetallen
Guide pour le traitement statistique des données de validation de méthodes d'analyse,
issues d'essais interlaboratoire
Ta slovenski standard je istoveten z: CEN/TR 10345:2008
ICS:
03.120.30 8SRUDEDVWDWLVWLþQLKPHWRG Application of statistical
methods
77.080.01 Železne kovine na splošno Ferrous metals in general
SIST-TP CEN/TR 10345:2008 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN/TR 10345:2008

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SIST-TP CEN/TR 10345:2008
TECHNICAL REPORT
CEN/TR 10345
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
June 2008
ICS 03.120.30; 17.020

English Version
Guideline for statistical data treatment of inter laboratory tests
for validation of analytical methods
Guide pour le traitement statistique des données de Richtlinien für statistische Verfahren der Probenahme und
validation de méthodes d'analyse, issues d'essais Analyse von Eisen, Stahl und anderen Eisenmetallen
interlaboratoire
This Technical Report was approved by CEN on 22 October 2007. It has been drawn up by the Technical Committee ECISS/TC 20.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TR 10345:2008: E
worldwide for CEN national Members.

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SIST-TP CEN/TR 10345:2008
CEN/TR 10345:2008 (E)
Contents Page
Foreword.3
1 Scope .4
2 Normative references .4
3 Principle.4
4 Preliminary rules.4
4.1 First rule (‘to be clear’) .4
4.2 Second rule (‘to be modest’) .5
4.3 Minimal characteristics of data population.5
5 Procedure .6
5.1 Bases .6
5.2 Raw data examination .6
5.3 Intra laboratory repeatability variance (Cochran’s test).6
5.4 Intra laboratory reproducibility variance (Grubbs’ test).6
5.5 Inter laboratory reproducibility variance (Grubbs’ test).7
5.6 Retained data examination .8
5.7 Calculation of the variances associated to the tested method.8
5.8 Treatment for unexpected calculated variances .8
5.9 Estimation of a function linking variance and level.
...