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AS ISO 20776.2:2024

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AS ISO 20776.2:2024

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Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices, Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution

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AS ISO 20776.2:2024 identically adopts ISO 20776 2:2021, which establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories. It also specifies requirements for AST devices and procedures for assessing performance of such devices, and it defines how a performance evaluation of an AST device is to be conducted.

Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
3.10
3.10.4
3.11
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
Annex B
Annex C
Bibliography

Cited references in this standard
Content history
DR AS ISO 20776.2:2024

Please select a variation to view its description.

Published

13/09/2024
Pages

16

Please select a variation to view its pdf.

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AS ISO 20776.2:2024
$125.14