I.S. EN ISO 16140-4:2020
Current
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Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
Hardcopy , PDF
English
14-09-2020
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles of the single-laboratory detection or quantification method validation
5 Technical protocol for validation — Factorial approach
6 Technical protocol for validation — Conventional approach
7 Summary of acceptability limits
Annex A (informative) List of factors and factor levels for factorial method validation
Annex B (informative) Calculation of in-house reproducibility for qualitative methods based on the LOD50 study described in 6.1.2.3
Annex C (informative) Example of a factorial single-laboratory method validation study for a quantitative method against a reference method
Annex D (informative) Example of a factorial single-laboratory method validation study for a qualitative method against a reference method
Annex E (informative) Example of a factorial single-laboratory method validation study for the variability of the LOD50 for a qualitative method without a reference method
Annex F (informative) Determination of precision if the artificially contaminated samples are unstable
Annex G (informative) Protocol for single-laboratory validation of alternative methods for microbiological confirmation and typing procedures
Bibliography
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