EN ISO 20776-1:2020

Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases (ISO 20776-1:2019, including Corrected version 2019-12) EN ISO 20776-1:2020

Publication date:   Nov 17, 2020

General information

60.60 Standard published   Jul 1, 2020

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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Scope

This document describes one reference method, broth micro-dilution, for determination of MICs. The MIC can be a guide for the clinician, and reflects the activity of the drug under the described test conditions, by taking into account other factors, such as drug pharmacology, pharmacokinetics, or bacterial resistance mechanisms. This allows categorisation of bacteria as "susceptible" (S), "intermediate" (I), or "resistant" (R). In addition, MIC distributions can be used to define wild type or non-wild type bacterial populations. Although clinical interpretation of the MIC value is beyond the scope of this document, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate annex of this document. It is necessary to compare other susceptibility testing methods (e.g. disc diffusion or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 20776-1:2006

NOW

PUBLISHED
EN ISO 20776-1:2020
60.60 Standard published
Jul 1, 2020