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PREN ISO 16140 : DRAFT 1999

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
Superseded date

05-01-2003

Published date

01-12-2013

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

Gives the general principle and the technical protocol for the validation of alternative methods in the field of microbiological analysis of food, animal feeding stuff and related areas for: a. the validation of alternatives methods to be used for official control; b. the international acceptance of the results obtained by the alternative method.

Committee
TC 275
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded
SupersededBy

Standards Relationship
99/715416 DC : DRAFT NOV 99 Identical

02/700233 DC : DRAFT FEB 2002 ISO/DIS 7937 - MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - HORIZONTAL METHOD FOR THE ENUMERATION OF CLOSTRIDIUM PERFRINGENS - COLONY-COUNT TECHNIQUE

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

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