DD ENV ISO/TR 13843:2001
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Water quality. Guidance on validation of microbiological methods
Hardcopy , PDF
31-08-2017
English
11-10-2001
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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Superseded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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