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DD ENV ISO/TR 13843:2001

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by

Water quality. Guidance on validation of microbiological methods

Available format(s)

Hardcopy , PDF

Superseded date

08-31-2017

Superseded by

BS EN ISO 13843:2017

Language(s)

English

Published date

10-11-2001

US$359.44
Excluding Tax where applicable

Foreword
1 Scope
2 Terms and definitions
3 Arrangement of the document
4 Basic concepts
   4.1 Basic concepts
   4.2 Validation
   4.3 Detectors
   4.4 Performance characteristics
   4.5 Specifications
5 Limitations and characteristics features of
   microbiological methods
   5.1 Recovery of the analyte
   5.2 Sample variance
   5.3 Particle distribution and over dispersion
   5.4 Interactions in the detector
   5.5 Robustness
   5.6 Spurious errors
   5.7 Control and guidance charts
6 Mathematical models of variation
   6.1 Unavoidable basic variation - The Poisson
        distribution
   6.2 Over dispersion - The negative binomial model
   6.3 Statistical and practical limits
   6.4 General tests for randomness - Detection of
        over dispersion
7 Specifications - Current practice
8 Specifications - Recommended approach
9 Determination and expression of performance
   characteristics
   9.1 General
   9.2 Categorical characteristics related to
        specifity and selectivity
   9.3 Working limits
   9.4 Working range of MPN procedures
   9.5 Precision
10 Procedures and steps of validation
   10.1 General
   10.2 Primary validation
   10.3 Secondary validation
11 Designs for determining specifications
   11.1 A general model for basic quantitative
        specifications
   11.2 Precision of the entire analytical procedure
   11.3 Categorical characteristics
   11.4 Unplanned data
Annex A Statistical procedures and computer programs
Annex B Numerical examples
Annex C Example of a validation experiment
Bibliography

Deals with the validation of microbiological methods, with particular emphasis on selective quantitative methods in which the quantitative estimate is based on counting of particles either directly, with the aid of a microscope, or indirectly, on the basis of growth into colonies or turbidity.

Committee
EH/3/4
DevelopmentNote
Reviewed and confirmed by BSI, July 2008. (06/2008)
DocumentType
Standard
Pages
56
PublisherName
British Standards Institution
RevisionOf
Status
Superseded
SupersededBy

Standards Relationship
ISO/TR 13843:2000 Identical
ENV ISO 13843:2001 Identical

BS 8496:2007 Water quality. Enumeration of micro-organisms in water samples. Guidance on the estimation of variation of results with particular reference to the contribution of uncertainty of measurement
BS DD260(2003) : 2003 WATER QUALITY - ENUMERATION OF MICRO-ORGANISMS IN WATER SAMPLES - GUIDANCE ON THE ESTIMATION OF VARIATION OF RESULTS WITH PARTICULAR REFERENCE TO THE CONTRIBUTION OF UNCERTAINTY OF MEASUREMENT

ISO 7218:2007 Microbiology of food and animal feeding stuffs — General requirements and guidance for microbiological examinations
ISO 5725:1986 Precision of test methods Determination of repeatability and reproducibility for a standard test method by inter-laboratory tests
ISO 9998:1991 Water quality Practices for evaluating and controlling microbiological colony count media used in water quality tests
ISO 3534-1:2006 Statistics — Vocabulary and symbols — Part 1: General statistical terms and terms used in probability

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