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