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BS EN ISO 16140-2:2016

Current
Current

The latest, up-to-date edition.

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

07-31-2016

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

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

Committee
AW/9
DevelopmentNote
Together with BS EN ISO 16140-1, it supersedes BS EN ISO 16140. Supersedes 13/30213816 DC. (08/2016)
DocumentType
Standard
PublisherName
British Standards Institution
Status
Current
Supersedes

Standards Relationship
EN ISO 16140-2:2016 Identical
ISO 16140-2:2016 Identical

ISO 16297:2013 Milk Bacterial count Protocol for the evaluation of alternative methods
ISO 16140-1:2016 Microbiology of the food chain Method validation Part 1: Vocabulary
ISO/TS 22117:2010 Microbiology of food and animal feeding stuffs Specific requirements and guidance for proficiency testing by interlaboratory comparison
ISO 11133:2014 Microbiology of food, animal feed and water — Preparation, production, storage and performance testing of culture media
ISO 5725-2:1994 Accuracy (trueness and precision) of measurement methods and results Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method

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