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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
Hardcopy , PDF
31-08-2017
English
11-10-2001
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
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