DIN EN ISO 16140:2011-12

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) Robust estimator of dispersion based
        on the recursive median Sn from Rousseeuw [6]
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
Bibliography