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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) EN ISO 20776-2:2022

Publication date:   May 16, 2022

General information

60.60 Standard published   Jan 19, 2022

CEN

CEN/TC 140 In vitro diagnostic medical devices

European Norm

11.100.20   Biological evaluation of medical devices

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
EN ISO 20776-2:2007

NOW

PUBLISHED
EN ISO 20776-2:2022
60.60 Standard published
Jan 19, 2022