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BSI PD CEN/TR 10345:2013

$189.07

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

Published By Publication Date Number of Pages
BSI 2013 48
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This Technical Report 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 5725-1:1994, ISO 5725-2:1994 and ISO 5725-3:1994 for the treatment of the data collected under the conditions used within the ECISS/TC 102 working groups.

NOTE The present document is not a simplification of the ISO 5725 standard, which is the only reference document.

PDF Catalog

PDF Pages PDF Title
4 Contents Page
5 Foreword
6 1 Scope
2 Normative references
3 Principle
4 Preliminary rules
4.1 First rule (‘to be clear’)
7 4.2 Second rule (‘to be modest’)
4.3 Minimal characteristics of data population
8 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)
9 5.5 Inter laboratory reproducibility variance (Grubbs’ test)
10 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
11 6 Report
7 General remarks
12 Annex A (normative) Steps for the validation of a draft Standard
A.1 Decision from a TC to create a working group
Figure A.1 — Example of selection of P samples
A.2 Laboratories performance on the specified tests
13 A.3 Statistical work to be done at each level (for each of the P samples)
A.3.1 General
A.3.2 Intra laboratory repeatability variance (Cochran’s test: ISO 5725-2:1994, 7.3.3)
A.3.3 Intra laboratory reproducibility variance (Grubbs’ test: ISO 5725-2:1994, 7.3.4)
14 A.3.4 Inter laboratories reproducibility variance (Grubbs’ test: ISO 5725-2:1994, 7.3.4)
A.3.5 Inter level laboratory performance
15 Annex B (normative) Synoptic of the operations described in Annex A
20 Annex C (informative) Examples
C.1 Nickel alloys – Determination of tantalum content – Inductively coupled plasma emission spectrometric method – ISO 22725
C.1.1 Original data
21 C.1.2 Cochran test
22 C.1.3 New table containing the set of laboratories having the same intra laboratory repeatability variance for further tests
23 C.1.4 Grubbs test, for intra laboratory reproducibility variance
24 C.1.5 New table containing the set of laboratories having the same intra laboratory reproducibility variance for further tests
C.1.6 Grubbs test, for inter laboratory reproducibility variance
25 C.1.7 New table containing the set of laboratories having the same inter laboratory reproducibility variance for further evaluations
26 C.2 Steel and iron – Determination of Nitrogen content –Thermal conductimetric method after fusion in a current of inert gas – ISO 10720
C.2.1 Original data
27 C.2.2 Cochran test
C.2.3 New table containing the set of laboratories having the same intra laboratory repeatability variance for further tests
28 C.2.4 Grubbs test, for intra laboratory reproducibility variance
30 C.2.5 New table containing the set of laboratories having the same intra laboratory reproducibility variance for further tests
31 C.2.6 Grubbs test, for inter laboratory reproducibility variance
32 C.2.7 New table containing the set of laboratories having the same inter laboratory reproducibility variance for further evaluations
33 C.3 Steel and iron – Determination of chromium content – Indirect titration method – ISO 15355
C.3.1 Original data
C.3.2 Cochran test
34 C.3.3 New table containing the set of laboratories having the same intra laboratory repeatability variance for further tests
C.3.4 Grubbs test, for intra laboratory reproducibility variance
36 C.3.5 New table containing the set of laboratories having the same intra laboratory reproducibility variance for further tests
C.3.6 Grubbs test, for inter laboratory reproducibility variance
37 C.3.7 New table containing the set of laboratories having the same inter laboratory reproducibility variance for further evaluations
38 C.4 Steel and iron – Determination of Nitrogen content –Thermal conductimetric method after fusion in a current of inert gas – ISO 10720
C.4.1 Original data
39 C.4.2 Cochran test
C.4.3 New table containing the set of laboratories having the same intra laboratory repeatability variance for further tests
40 C.4.4 Grubbs test, for intra laboratory reproducibility variance
42 C.4.5 New table containing the set of laboratories having the same intra laboratory reproducibility variance for further tests
C.4.6 Grubbs test, for inter laboratory reproducibility variance
44 C.4.7 New table containing the set of laboratories having the same inter laboratory reproducibility variance for further evaluations
45 C.5 General remarks about the examples shown
46 Bibliography
BSI PD CEN/TR 10345:2013
$189.07