ДСТУ EN ISO 13843:2022 Якість води. Вимоги до встановлення характеристик ефективності кількісних мікробіологічних методів (EN ISO 13843:2017, IDT; ISO 13843:2017, IDT)

ДСТУ EN ISO 13843:2022
(EN ISO 13843:2017, IDT; ISO 13843:2017, IDT)

Якість води. Вимоги до встановлення характеристик ефективності кількісних мікробіологічних методів

 
   
 
 
     
Не є офіційним виданням.
Офіційне видання розповсюджує національний орган стандартизації
(ДП «УкрНДНЦ» http://uas.gov.ua)

Contents

European foreword

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