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