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ISO 13843:2017 Water quality - Requirements for establishing performance characteristics of quantitative microbiological methods >
ISO 13843:2017 Water quality - Requirements for establishing performance characteristics of quantitative microbiological methods, 2017
- 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
- 6.2.1 Type of samples to be used
- 6.2.2 Number of samples
- 6.2.3 Procedure
- 6.2.4 Categorical performance characteristics
- 6.2.5 Worked example
- 6.3 Determination of the upper limit and consideration of the lower limit of detection
- 6.3.1 Working range
- 6.3.2 Upper limit related to linearity
- 6.3.3 Type and number of samples to be used
- 6.3.4 Worked example
- 6.3.5 The lower limit of detection
- 6.4 Assessment of precision: Determination of repeatability and reproducibility
- 6.4.1 General
- 6.4.2 Repeatability
- 6.4.3 Intralaboratory reproducibility
- 6.5 Robustness
- 6.5.1 General
- 6.5.2 Experimental designs for effects due to time and temperature
- 6.6 Relative recovery
- 6.6.1 General
- 6.6.2 Determination of relative recovery
- 6.7 Uncertainty of counting
- 6.7.1 General
- 6.7.2 Experimental design for assessing the uncertainty of counting colonies
- 6.7.3 Example of individual (or personal) uncertainty of counting colonies
- 6.7.4 Example of intralaboratory uncertainty of counting colonies
- 6.7.5 Example of intralaboratory uncertainty of reading MPN
- 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
- 7.2.1 Type of sample to be used
- 7.2.2 Number of samples
- 7.2.3 Procedure for confirmation
- 7.2.4 Categorical performance characteristics
- 7.3 Determination of repeatability
- 7.4 Uncertainty of counting
- 7.5 Procedure for single laboratory verification
- 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 [Go to Page]