NF EN ISO 20776-1

NF EN ISO 20776-1

April 2007
Standard Cancelled

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

ISO 20776-1:2006 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization 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 ISO 20776-1:2006, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

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Main informations

Collections

National standards and national normative documents

Publication date

April 2007

Release date

juillet 2023 par NF EN ISO 20776-1 de 2007

Number of pages

30 p.

Reference

NF EN ISO 20776-1

ICS Codes

11.100.20   Biological evaluation of medical devices

Classification index

S92-053-1

Print number

1 - 12/04/2007

International kinship

ISO 20776-1:2006

European kinship

EN ISO 20776-1:2006
Sumary
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

ISO 20776-1:2006 describes one reference method, broth microdilution, for determination of MICs. The MIC reflects the activity of the drug under the described test conditions, and can be interpreted for clinical management purposes by taking into account other factors, such as drug pharmacology or bacterial resistance mechanisms. This allows categorization 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 ISO 20776-1:2006, modifications of the basic method are required for certain antimicrobial agent - bacteria combinations to facilitate clinical interpretation. These modifications are included in a separate table. It is advisable to compare other susceptibility testing methods (e.g. routine methods or diagnostic test devices) with this reference method for validation, in order to ensure comparable and reliable results.

Standard replaced by (1)
NF EN ISO 20776-1
July 2020
Standard Current
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

<p>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.</p>

Table of contents
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  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Termes et définitions
    1
  • 3 Modes opératoires
    4
  • 3.1 Généralités
    4
  • 3.2 Milieu
    4
  • 3.3 Agents antimicrobiens
    4
  • 3.4 Préparation de l'inoculum
    10
  • 3.5 Inoculation des plaques de microdilution
    11
  • 3.6 Incubation des plaques de microdilution
    11
  • 3.7 Résultats des lectures
    11
  • 3.8 Situations spécifiques pour lesquelles le résultat de la CMI peut donner des résultats peu fiables
    11
  • 4 Contrôle de qualité
    13
  • Annexe A (normative) Exigences relatives au bouillon Mueller-Hinton
    17
  • Bibliographie
    19
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