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ISO 20776-1:2019

(Main)

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

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

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.

Sensibilité in vitro des agents infectieux et évaluation des performances des dispositifs pour antibiogrammes — Partie 1: Méthode de référence de microdilution en bouillon pour la détermination de la sensibilité in vitro aux agents antimicrobiens des bactéries aérobies à croissance rapide impliquées dans les maladies infectieuses

Le présent document décrit une méthode de référence, la microdilution en bouillon, pour déterminer les CMI. La CMI peut constituer un guide pour le clinicien et reflète l'activité du médicament dans les conditions d'essai décrites, en tenant compte d'autres facteurs tels que la pharmacologie du médicament, la pharmacocinétique ou les mécanismes de résistance bactérienne. Cela permet de classer les bactéries comme étant «sensibles» (S), «intermédiaires» (I) ou «résistantes» (R). En outre, les distributions de CMI peuvent être utilisées pour définir les populations bactériennes de type sauvage ou non sauvage. Bien que l'interprétation clinique de la valeur de la CMI se trouve au-delà du domaine d'application du présent document, des modifications de la méthode de base sont nécessaires pour certaines combinaisons agent antimicrobien-bactérie afin de faciliter l'interprétation clinique. Ces modifications sont incluses dans une annexe séparée du présent document. Il est nécessaire de comparer les autres méthodes d'essai de sensibilité (par exemple, les méthodes de diffusion en gélose ou les dispositifs d'essai de diagnostic) à cette méthode de référence à des fins de validation et pour garantir des résultats comparables et fiables.

General Information

Status
Published
Publication Date
04-Jun-2019
ICS
11.100.20 - Biological evaluation of medical devices
Technical Committee
ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Drafting Committee
ISO/TC 212 - Clinical laboratory testing and in vitro diagnostic test systems
Current Stage
9020 - International Standard under periodical review
Start Date
15-Apr-2024
Completion Date
15-Apr-2024
Ref Project

Relations

Consolidates
ISO 23500:2014 - Guidance for the preparation and quality management of fluids for haemodialysis and related therapies
Effective Date
06-Jun-2022
Revises
ISO 20776-1:2006 - Clinical laboratory testing and in vitro diagnostic test systems — Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices — Part 1: Reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
Effective Date
19-Dec-2015

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Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 20776-1
Second edition
2019-06
Corrected version
2019-12
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
Sensibilité in vitro des agents infectieux et évaluation des
performances des dispositifs pour antibiogrammes —
Partie 1: Méthode de référence de microdilution en bouillon pour la
détermination de la sensibilité in vitro aux agents antimicrobiens des
bactéries aérobies à croissance rapide impliquées dans les maladies
infectieuses
Reference number
ISO 20776-1:2019(E)
©
ISO 2019

---------------------- Page: 1 ----------------------
ISO 20776-1:2019(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

---------------------- Page: 2 ----------------------
ISO 20776-1:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Test procedures . 3
4.1 General . 3
4.2 Medium . 3
4.3 Antimicrobial agents . 3
4.3.1 General. 3
4.3.2 Preparation of stock solutions . 3
4.3.3 Preparation of working solutions . 4
4.3.4 Preparation of micro-dilution trays . 4
4.3.5 Storage of micro-dilution trays . 4
4.4 Preparation of inoculum . 5
4.4.1 General. 5
4.4.2 Broth culture method .
...

NORME ISO
INTERNATIONALE 20776-1
Deuxième édition
2019-06
Version corrigée
2019-12
Sensibilité in vitro des agents
infectieux et évaluation des
performances des dispositifs pour
antibiogrammes —
Partie 1:
Méthode de référence de
microdilution en bouillon pour la
détermination de la sensibilité in
vitro aux agents antimicrobiens
des bactéries aérobies à croissance
rapide impliquées dans les maladies
infectieuses
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
Numéro de référence
ISO 20776-1:2019(F)
©
ISO 2019

---------------------- Page: 1 ----------------------
ISO 20776-1:2019(F)

DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2019
Tous droits réservés. Sauf prescription différente ou nécessité dans le contexte de sa mise en œuvre, aucune partie de cette
publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,
y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut
être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.
ISO copyright office
Case postale 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Genève
Tél.: +41 22 749 01 11
Fax: +41 22 749 09 47
E-mail: copyright@iso.org
Web: www.iso.org
Publié en Suisse
ii © ISO 2019 – Tous droits réservés

---------------------- Page: 2 ----------------------
ISO 20776-1:2019(F)

Sommaire Page
Avant-propos .iv
Introduction .vi
1 Domaine d’application . 1
2 Références normatives . 1
3 Termes et définitions . 1
4 Modes opératoires d’essai . 3
4.1 Généralités . 3
4.2 Milieu . 3
4.3 Agents antimicrobiens. 3
4.3.1 Généralités . 3
4.3.2 Préparation des solutions mères . 4
4.3.3 Préparation des solutions de travail . 4
4.3.4 Préparation de plaques de microdilution. 4
4.3.5 Stockage des plaques de microdilution . 5
4.4 Préparation de l’inoculum . 5
4.4.1 Généralités . 5
4.4.2 Méthode de culture en bouillon . 5
4.4.3
...

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