BS EN ISO 16140-2:2016

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.