DIN EN ISO 16140:2011-12
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - PROTOCOL FOR THE VALIDATION OF ALTERNATIVE METHODS (ISO 16140:2003 + AMD.1:2011)
Hardcopy , PDF
01-11-2016
German
01-01-2011
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
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