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DIN EN ISO 16140:2011-12

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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MICROBIOLOGY OF FOOD AND ANIMAL FEEDING STUFFS - PROTOCOL FOR THE VALIDATION OF ALTERNATIVE METHODS (ISO 16140:2003 + AMD.1:2011)

Available format(s)

Hardcopy , PDF

Superseded date

01-11-2016

Language(s)

German

Published date

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

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 environmental and veterinary samples for: - the validation of alternative methods which can be used in particular in the framework of the official control; - the international acceptance of the results obtained by the alternative method.

DevelopmentNote
Supersedes DIN 10900-42 (10/2003)
DocumentType
Standard
Pages
91
PublisherName
German Institute for Standardisation (Deutsches Institut für Normung)
Status
Superseded
SupersededBy
Supersedes

DIN EN ISO 8199:2008-01 Water quality - General guidance on the enumeration of micro-organisms by culture (ISO 8199:2005)
DIN EN ISO 22118:2011-11 Microbiology of food and animal feeding stuffs - Polymerase chain reaction (PCR) for the detection and quantification of food-borne pathogens - Performance characteristics (ISO 22118:2011)

DIN ISO 11095:2008-04 LINEAR CALIBRATION USING REFERENCE MATERIALS
ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
DIN ISO 5725-2:2002-12 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 5725-2:1994 including Technical Corrigendum 1:2002)
DIN ISO 3534-1:2009-10 STATISTICS - VOCABULARY AND SYMBOLS - PART 1: GENERAL STATISTICAL TERMS AND TERMS USED IN PROBABILITY
ISO 11095:1996 Linear calibration using reference materials
ISO 3534-2:2006 Statistics — Vocabulary and symbols — Part 2: Applied statistics
EN ISO 9001:2015 Quality management systems - Requirements (ISO 9001:2015)
ISO 9001:2015 Quality management systems — Requirements
ISO 5725:1986 Precision of test methods Determination of repeatability and reproducibility for a standard test method by inter-laboratory tests
DIN ISO 3534-2:2013-12 STATISTICS - VOCABULARY AND SYMBOLS - PART 2: APPLIED STATISTICS (ISO 3534-2:2006)
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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