Hrvatski normativni dokument

Oznaka: HRN EN ISO 20776-1:2008

Naslov (HR):
Klinička laboratorijska ispitivanja i in vitro dijagnostički ispitni sustavi -- Ispitivanje osjetljivosti infektivnih agensa i procjena svojstava antimikrobne osjetljivosti ispitnih proizvoda -- 1. dio: Referentna metoda za ispitivanje in vitro djelovanja antimikrobnih agensa protiv brzog rasta aerobnih bakterija koje uzrokuju infektivne bolesti (ISO 20776-1:2006; EN ISO 20776-1:2006)

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

Područje primjene (EN):
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.

Izdanje: 1

ICS:

• 11.100 Laboratorijska medicina

Tehnički odbor/pododbor: TO 555, Medicinski proizvodi

Oznaka faze: 95.99 - povlačenje HRN

Glasilo (rasprava): 5/2008 (31.10.2008.)

Glasilo (objava): 6/2008 (31.12.2008.)

Glasilo (povlačenje): 7/2020 (31.07.2020.)

Način prihvaćanja: pr - prihvaćanje strane norme u izvorniku

Izvornik: EN ISO 20776-1:2006

Zamjenjena s: HRN EN ISO 20776-1:2020

Direktiva/Uredba: 98/79/EC