BS EN ISO 20776-2:2021 – TC:2022 Edition

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Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution

Published By	Publication Date	Number of Pages
BSI	2022	68

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Categories: 11.100.20 - Biological evaluation of medical devices, BSI

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PDF Pages

PDF Title

30451210

A-30425531

National foreword

European foreword

Foreword

Introduction

1 Scope
2 Normative references
3 Terms and definitions

3.10 Terms relating to the evaluation of test results
3.10.4 Terms relating to sensitivity analysis

3.11 Terms relating to bacterial isolates

4 Test methods
4.1 General
4.2 Methods
4.2.1 Reference method
4.2.2 Strain selection

4.2.3 Quality control (QC)
4.2.4 Quality control (QC) of the reference method
4.2.5 Reproducibility testing of test device

4.2.6 Isolate testing protocol
4.2.7 Inoculum preparation
4.2.8 Discrepancy resolution testing
4.2.9 System under evaluation

5 Data analysis and acceptance criteria
5.1 Accuracy of test device
5.1.1 General
5.1.2 MIC devices
5.1.3 Qualitative AST devices
5.2 Quality control (QC) of test device
5.3 Reproducibility of test device
5.4 Documents related to study

Annex A (informative) Evaluating the performance of MIC tests

Annex B (informative) Rationale for bias analysis

Annex C (informative) Sensitivity and specificity analyses for qualitative tests

Bibliography

Status	Definitive
Pages	68
Publication Date	2022-02-01
ISBN	978 0 539 21052 1
Standard Number	BS EN ISO 20776-2:2021 – TC
Title	Tracked Changes. Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
Descriptors	Biological hazards, Performance testing, Microorganisms, Drugs, Clinical testing, Biological analysis and testing, Clinical medicine, Bacteria, Pathogens, Laboratory testing, Diagnosis (medical), Antibiotics, Testing conditions
Publisher	BSI
Committee	CH/212
ICS Codes	11.100.20 - Biological evaluation of medical devices