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EVS-EN 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 devices - Part 1: Reference methods for testing the in vitro activity of antimicrobial agents against bacteria involved in infectious diseases

General information
Withdrawn from 16.07.2020
Base Documents
ISO 20776-1:2006; EN ISO 20776-1:2006

Although the standard’s status is withdrawn, it still has the presumption of conformity in the meaning of regulation 98/79/EC and conformance with the regulation ’s requirements can be guaranteed by using the withdrawn version of the standard. The presumption of conformity is valid until a corresponding amendment is published in the Official Journal of the European Union.
 
To view the latest lists of harmonised standards published in the Official Journal of the European Union, visit: 
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/

Standard history
Status
Date
Type
Name
16.07.2020
Main
04.01.2007
Main
This part of ISO 20776 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 this part of ISO 20776, 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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