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BS EN ISO 16140-2:2016

BS EN ISO 16140-2:2016

$215.11

Microbiology of the food chain. Method validation – Protocol for the validation of alternative (proprietary) methods against a reference method

Published By Publication Date Number of Pages
BSI 2016 78
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PDF Catalog

PDF Pages PDF Title
4 European foreword
Endorsement notice
6 Foreword
7 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
4 General principles for the validation of alternative methods
10 5 Qualitative methods ā€” Technical protocol for validation
5.1 Method comparison study
5.1.1 General considerations
5.1.2 Paired or unpaired study
5.1.3 Sensitivity study
15 5.1.4 Relative level of detection study
17 5.1.5 Inclusivity and exclusivity study
18 5.2 Interlaboratory study
5.2.1 General considerations
5.2.2 Measurement protocol
20 5.2.3 Calculations and summary of data
23 5.2.4 Interpretation of data
24 6 Quantitative methods ā€” Technical protocol for validation
6.1 Method comparison study
6.1.1 General considerations
6.1.2 Relative trueness study
28 6.1.3 Accuracy profile study
32 6.1.4 Limit of quantification study
6.1.5 Inclusivity and exclusivity study
34 6.2 Interlaboratory study
6.2.1 General considerations
6.2.2 Measurement protocol
35 6.2.3 Calculations, summary, and interpretation of data
38 AnnexĀ A (informative) Classification of sample types and suggested target combinations for validation studies
54 AnnexĀ B (normative) Order of preference for use of naturally and artificially contaminated samples in validation studies
55 AnnexĀ C (informative) General protocols for contamination by mixture and artificial contamination of foods
58 AnnexĀ D (informative) Models for RLOD calculations using data from the method comparison study
60 AnnexĀ E (normative) Points to be considered when selecting strains for testing inclusivity and exclusivity
62 AnnexĀ F (informative) Considerations for calculations of the relative level of detection (RLOD) between laboratories as obtained in an interlaboratory study
65 AnnexĀ G (informative) Principle of the accuracy profile for validation of quantitative models
67 AnnexĀ H (informative) Application of the accuracy profile in the method comparison study
70 AnnexĀ I (informative) Example of the application of the accuracy profile for an interlaboratory study
74 Bibliography

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BS EN ISO 16140-2:2016
$215.11