Table of Contents

Foreword<br>Introduction<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 General principles for the validation of alternative<br>&nbsp;&nbsp;methods<br>5 Qualitative methods - Technical protocol for validation<br>6 Quantitative methods - Technical protocol for validation<br>Annex A (informative) - Classification of sample types<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;and suggested target combinations for validation<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;studies<br>Annex B (normative) - Order of preference for use of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;naturally and artificially contaminated samples<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;in validation studies<br>Annex C (informative) - General protocols for<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;contamination by mixture and artificial<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;contamination of foods<br>Annex D (informative) - Models for RLOD calculations<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;using data from the method comparison study<br>Annex E (normative) - Points to be considered when<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;selecting strains for testing inclusivity and<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;exclusivity<br>Annex F (informative) - Considerations for calculations of<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;the relative level of detection (RLOD) between<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;laboratories as obtained in an interlaboratory<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;study<br>Annex G (informative) - Principle of the accuracy profile<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;for validation of quantitative models<br>Annex H (informative) - Application of the accuracy<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;profile in the method comparison study<br>Annex I (informative) - Example of the application of the<br>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;accuracy profile for an interlaboratory study<br>Bibliography

Abstract

Defines the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain.

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Published
Document Type	Standard
Status	Current
Publisher	British Standards Institution
Pages
ISBN
Committee	AW/9
Supersedes	13/30213816 DC : 0