EN ISO 16140-2:2016

European foreword
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

ISO 16140-2:2016 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to ISO 16140-2:2016 are intended to be performed by organizations involved in method validation.It is applicable to the validation of methods for the analysis (detection or quantification) of microorganisms in- products intended for human consumption,- products intended for animal feeding,- environmental samples in the area of food and feed production, handling, and- samples from the primary production stage.It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in ISO 16140:2016 (all parts).