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 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)

Publication date:   Apr 30, 2007

General information

99.60 Withdrawal effective   Jul 1, 2020

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100   Laboratory medicine

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Scope

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.

Related legislation

Legislation related to this standard

98/79/EC

In vitro diagnostic medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN ISO 20776-1:2006
99.60 Withdrawal effective
Jul 1, 2020

REVISED BY

PUBLISHED
EN ISO 20776-1:2020