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BSI 23/30473448 DC 2023

BSI 23/30473448 DC 2023

$13.70

BS ISO 33406. Guidance for the production of reference materials with qualitative properties

Published By Publication Date Number of Pages
BSI 2023 47
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PDF Catalog

PDF Pages PDF Title
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
10 4 Meeting technical and production requirements
4.1 Characterization
4.1.1 General considerations
4.1.2 Materials characterized based on provenance
4.1.3 Materials characterized for identity based on measurements
11 4.1.4 Characterization by a combination of methods
12 4.2 Application of metrological traceability to qualitative determinations
4.2.1 General
13 4.2.2 Metrological traceability
4.2.3 Reference data and reference materials for qualitative determinations
14 4.2.4 Qualitative value assigned based on provenance
4.3 Measurement uncertainty and confidence in qualitative values
4.3.1 General considerations
15 4.3.2 Measurement uncertainty
4.3.3 Confidence in qualitative values
17 4.4 General considerations for the selection of statistical approaches
4.5 Assessment of homogeneity
4.5.1 General considerations
18 4.5.2 Experimental designs for homogeneity assessment for qualitative values
19 4.5.3 Statistical approaches for homogeneity assessment for qualitative properties
21 4.6 Assessment of stability
4.6.1 General considerations for stability assessment
4.6.2 Designs for experimental stability studies for qualitative properties
23 4.7 Commutability assessment
4.7.1 General considerations
24 4.7.2 Commutability assessment for qualitative properties
25 4.7.3 Commutability statement
26 Annex€A (informative) Guidance for DNA and protein reference materials
29 Annex€B (informative) Expressing confidence in qualitative values
36 Annex€C (informative) Statistical procedures
40 Annex€D (informative) Examples of homogeneity and stability studies of reference materials with qualitative properties
45 Bibliography

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BSI 23/30473448 DC 2023
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