DIN EN ISO 16140:2003-09

National foreword
National Annex NA (informative) - Bibliography
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 (informative) - 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 me
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 for: - the validation of alternative methods which can be used in particular in the framework of the official control; - the international acceptance of the results obtained by the alternative method.