AS ISO 20776.2:2017

$87.96

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

Adopts ISO 20776-2:2007, which establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MICs) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories.

Table of contents
Header
About this publication
Preface
1 Scope
2 Normative references
3 Terms and definitions
3.1 Agreement of test results
3.6 Discrepancies
3.9 Clinical isolates
4 General requirements for a performance evaluation
5 Test methods
5.1 Overview
5.2 Methods
5.2.1 Strain selection
5.2.2 Isolate testing protocol
5.2.3 Inoculum preparation
5.2.4 Reproducibility testing of test device
5.2.5 Quality control (QC) of the reference method
5.2.6 Results
5.2.7 Discrepancy resolution testing
5.2.8 System under evaluation
5.3 Data analysis
5.4 Acceptance criteria
5.4.1 Accuracy of test device
5.4.2 Quality control of test device
5.4.3 Reproducibility of test device
5.5 Documents related to the study
Bibliography

Cited references in this standard
Content history

[Superseded]

DR AS ISO 20776.2:2016

Please select a variation to view its description.

Published

02/02/2017

Pages

9

Please select a variation to view its pdf.

AS ISO 20776.2:2017
$87.96