UNI EN ISO 16140 : 2011

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles for the validation and the certification
  of alternative methods
5 Qualitative methods - Technical protocol for their
  validation
6 Quantitative methods - Technical protocol for their
  validation
Annex A (normative) - Specific rules for the acceptance of
        external results already obtained in a prior
        validation scheme
Annex B (normative) - Classification of sample types for
        validation studies
Annex C (normative) - Use of naturally contaminated samples and
        preparation of artificially contaminated samples in
        validation studies
Annex D (normative) - Duplication of samples for the determination
        of relative accuracy and of relative detection level
        for qualitative methods
Annex E (normative) - Calculation of the confidence intervals
        associated with the number of samples tested
Annex F (normative) - Test applied to the examination of
        discordant results
Annex G (normative) - Points to be considered when selecting
        strains for testing selectivity
Annex H (normative) - Guidelines for the organisation and
        conducting collaborative studies
Annex I (normative) - Determination that negative controls are
        free of target analyte
Annex J (normative) - Replication of samples for interlaboratory
        studies of qualitative methods
Annex K (normative) - Consideration of data
Annex L (informative) - Interlaboratory study of qualitative
        methods: criteria of accordance, concordance and
        concordance odds ratio
Annex M (normative) - Replication of samples for the
        determination of relative accuracy of quantitative
        methods
Annex N (normative) - Examples of acceptable and unacceptable
        situations and range of measurements for the
        estimation of the regression line for quantitative
        methods
Annex O (normative) - Assessment of the linearity of
        quantitative methods by graphical representation
Annex P (normative) - Detection and quantification limits
        for counts
Annex Q (normative) - Calculation of Rousseeuw's scale
        estimator Q[n]
Annex R (normative) - Calculations with the regression method
Annex S (normative) - Examples of calculations for quantitative
        methods
Annex T (normative) - Collaborative study - Ring test results
        with duplicates
Annex U (informative) - List of symbols and abbreviations
Annex V (informative) - Indicators for Mandel's robust h-
        and k-statistics
Annex W (informative) - Example: Determination of E. coli
Bibliography

Gives the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuff and environmental and veterinary samples.