This International Standard gives guidelines for the evaluation of uncertainty in quantitative microbiological analyses based on enumeration of microbial particles by culture. It covers all variants of colony count methods and most probable number estimates. Two approaches, the component (also known as bottom-up or step-by-step) and a modified global (top-down) approach are included. The aim is to specify how values of intralaboratory operational variability and combined uncertainty for final test results can be obtained. The procedures are not applicable to methods other than enumeration methods.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Key concepts
2.1 Uncertainty of measurement
2.2 Estimation of the uncertainty of measurement
2.3 Intralaboratory reproducibility
2.4 Combined standard uncertainty
2.5 Relative standard uncertainty
2.6 Relative variance
2.7 Expanded uncertainty and expanded relative uncertainty
3 Microbiological methods
3.1 Common basis
3.2 Quantitative instruments
3.3 Uncertainty structure
3.4 Expression of combined uncertainty
4 Choices of approach
4.1 General
4.2 Choices of evaluation approach
4.3 Choices of expression and use of measurement uncertainty
5 The component approach to the evaluation of operational uncertainty
5.1 General
5.2 Identification of the components of uncertainty
5.3 Evaluation
6 The global approach to the determination of the operational uncertainty
6.1 General
6.2 Evaluation
7 Combined uncertainty of the test result
7.1 Basic principle
7.2 Operational variability
7.3 Intrinsic variability
7.4 Combined uncertainty
7.5 Borderline cases
Annex A Symbols and definitions (informative)
Annex B General principles for combining components of uncertainty (normative)
Annex C Intrinsic variability — Relative distribution uncertainty of colony counts (normative)
Annex D Intrinsic variability of most probable number estimates (normative)
Annex E Intrinsic variability (standard uncertainty) of confirmed counts (normative)
Annex F Global approach for determining the operational and combined uncertainties (normative)
Annex G Component approach to evaluation of the combined relative uncertainty under intralaboratory reproducibility conditions (normative)
Annex H Experimental evaluation of subsampling variance (normative)
Annex I Relative repeatability and intralaboratory reproducibility of volume measurements (normative)
Annex J Relative uncertainty of a sum of test portions (normative)
Annex K Relative uncertainty of dilution factor F (normative)
Annex L Repeatability and intralaboratory reproducibility of counting (normative)
Annex M Incubation effects — Uncertainty due to position and time (normative)
Annex N Expression and use of measurement uncertainty (informative)