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EVS-EN ISO 20776-2:2022

Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution (ISO 20776-2:2021)

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Kehtiv alates 01.02.2022
Alusdokumendid
ISO 20776-2:2021; EN ISO 20776-2:2022
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Staatus
Kuupäev
Tüüp
Nimetus
01.02.2022
Põhitekst
07.02.2008
Põhitekst
This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories. This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. This document has been developed to guide manufacturers in the conduct of performance evaluation studies.
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EVS-EN ISO 20776-1:2020

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)
Uusim versioon Kehtiv alates 16.07.2020
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EVS-EN ISO 10993-7:2008+A1:2022

Meditsiiniseadmete bioloogiline hindamine. Osa 7: Jäägid etüleenoksiidiga steriliseerimisest
Uusim versioon Kehtiv alates 01.02.2022