ENV ISO 13843 : DRAFT MAY 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