ISO 13843:2017 deals with characterization of microbiological methods. In terms of ISO 13843:2017, 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. ISO 13843:2017 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 ISO 13843:2017 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 ISO 13843:2017 should be considered carefully.
Tämän julkaisun valmistelusta Suomessa vastaa Suomen ympäristökeskus, puh. 040 724 8795.
Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Basic concepts
4.1 General
4.2 Characterization
4.3 Verification
4.4 Method comparison
4.5 Samples
5 Specifications: some guideline values
6 Designs for determining performance characteristics of a method
6.1 General considerations
6.2 Determination of sensitivity, specificity, efficiency, selectivity, false positive rate and false negative rate
6.3 Determination of the upper limit and consideration of the lower limit of detection
6.4 Assessment of precision: Determination of repeatability and reproducibility
6.5 Robustness
6.6 Relative recovery
6.7 Uncertainty of counting
7 Designs for single laboratory verification of a method
7.1 General considerations
7.2 Calculation of sensitivity, specificity, efficiency, selectivity, false positive rate and false negative rate
7.3 Determination of repeatability
7.4 Uncertainty of counting
7.5 Procedure for single laboratory verification
Annex A Mathematical models of variation (informative)
Annex B Assessment of the lower limits (normative)
Annex C Assessment of the upper limit (normative)
Annex D Determination of the operational variability in repeatability and intralaboratory reproducibility conditions (normative)
Annex E Uncertainty of counting (normative)
Annex F Determination of the operational variability (interlaboratory reproducibility) in a collaborative performance study (normative)
Annex G Glossary of principal symbols (informative)