PREN ISO 16140-2 : DRAFT 2013

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 artificially contamination of food
        matrices
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 in the field of microbiological analysis of food, animal feed, and environmental and primary production stage samples for the validation of alternative (proprietary) methods.