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