BS EN ISO 13843:2017

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Basic concepts
5 Specifications: some guideline values
6 Designs for determining performance characteristics
  of a method
7 Designs for single laboratory verification of a method
Annex A (informative) - Mathematical models of variation
Annex B (normative) - Assessment of the lower limits
Annex C (normative) - Assessment of the upper limit
Annex D (normative) - Determination of the operational
        variability in repeatability and intralaboratory
        reproducibility conditions
Annex E (normative) - Uncertainty of counting
Annex F (normative) - Determination of the operational
        variability (interlaboratory reproducibility) in a
        collaborative performance study
Annex G (informative) - Glossary of principal symbols
Bibliography

Specifies procedures for the determination of performance characteristics which can be used for subsequent validation or verification of methods.

This document deals with characterization of microbiological methods. In terms of this document, characterization means the study of parameters that can be measured to describe how the method is likely to perform in a given set of conditions, which can be described as performance characteristics. The document describes procedures for the determination of performance characteristics which can be used for subsequent validation or verification of methods.

The emphasis is on selective quantitative methods and this document applies to all types of water. For methods that are not based upon direct microscopic count, colony count or most probable number, the applicability of the procedures described in this document should be considered carefully.