SS-EN-ISO-20776-1 Historical Revision Information
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibiliyt devices - Part 1: Reference methods for testing the in vitro activity of antimicrobial agents against bacteria involved in infectious diseases (ISO 20776-1:2006)

SS-EN-ISO-20776-1 - 2006 EDITION - SUPERSEDED
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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.

To find similar documents by classification:

11.100.10 (In vitro diagnostic test systems)

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)


In vitro diagnostic medical devices

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Designation Name

SS-EN ISO 20776-1:2006

Revision Level

2006 EDITION

Status

Superseded

Publication Date

Nov. 24, 2006

Language(s)

English

Page Count

25

International Equivalent

EN ISO 20776-1:2006(IDT); ISO 20776-1:2006(IDT)