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Norm
ÖNORM EN ISO 20776-2
Issue date: 2022 05 01
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)
This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations...
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Valid
Publisher:
Austrian Standards International
Format:
Digital | 26 Pages
Language:
German
| English
| Download GER/ENG
Optionally co-design standards:
ICS
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.
ÖNORM EN ISO 20776-2
2022 05 01
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infecti...
Norm
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ÖNORM EN ISO 20776-2
2007 10 01
Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infecti...
Norm
Norm
ISO 20776-1:2019
Issue date :
2019 06 05
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 (Corrected version 2019-12)