PREN ISO 16140 : DRAFT 1999

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principle 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
        contamined samples in validation studies
Annex D (normative) Duplication of samples for the
        determination of relative accuracy and of
        relative detection level of 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 organization
        and conducting collaborative studies
Annex J (normative) Determination that negative controls
        are free of target analyte
Annex K (normative) Replication of samples for
        Interlaboratory studies of qualitative methods
Annex L (normative) Consideration of data
Annex M (normative) Replication of samples for the
        determination of relative accuracy of quantitative
        methods
Annex N (normative) Examples of unacceptable and acceptable
        repartitions and ranges of measures for the
        estimation of the regression straight line, for
        quantitative methods
Annex P (normative) Assessment of the linearity of quantitative
        methods by graphical representation
Annex Q (normative) Detection and quantification limits for
        counts
Annex R (normative) Robust estimator of dispersion based on
        the remedian Sn from Rousseeuw
Annex S (normative) Calculations with the regression method
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 related areas for: a. the validation of alternatives methods to be used for official control; b. the international acceptance of the results obtained by the alternative method.