99/715416 DC : DRAFT NOV 99
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
ISO 16140 - MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - PROTOCOL FOR THE VALIDATION OF ALTERNATIVE METHODS
23-11-2012
23-05-2003
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
| Committee |
AW/9
|
| DocumentType |
Draft
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| PREN ISO 16140 : DRAFT 1999 | Identical |
| ISO 5725-1:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions |
| ISO 11095:1996 | Linear calibration using reference materials |
| ISO 5725-2:1994 | Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method |
| ISO 3534-1:2006 | Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability |