Hrvatski normativni dokument

Oznaka: HRN EN ISO 20776-1:2020

Naslov (HR):
Ispitivanje osjetljivosti infektivnih agensa i procjena svojstava antimikrobne osjetljivosti ispitnih proizvoda -- 1. dio: Referentna metoda mikrorazrjeđivanja bujonom za ispitivanje in vitro djelovanja antimikrobnih agensa protiv brzog rasta aerobnih bakterija koje uzrokuju infektivne bolesti (ISO 20776-1:2019, ispravljena verzija 2019-12; EN ISO 20776-1:2020)

Naslov (EN):
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 (ISO 20776-1:2019, including Corrected version 2019-12; EN ISO 20776-1:2020)

Područje primjene (EN):
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.

Izdanje: 2

ICS:

• 11.100.20 Biološko vrednovanje medicinskih proizvoda

Tehnički odbor/pododbor: TO 555, Medicinski proizvodi

Oznaka faze: 60.60 - HRN dostupan

Glasilo (rasprava): HZN e-Glasilo 7/2018 (31.07.2018.)

Glasilo (objava): HZN e-Glasilo 7/2020 (31.07.2020.)

Način prihvaćanja: pr - prihvaćanje strane norme u izvorniku

Izvornik: EN ISO 20776-1:2020

Zamjenjuje: HRN EN ISO 20776-1:2008

Direktiva/Uredba: kandidat