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ISO 20776-2:2021

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

Publication date:   Dec 23, 2021

General information

60.60 Standard published   Dec 23, 2021

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

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WITHDRAWN
ISO 20776-2:2007

NOW

PUBLISHED
ISO 20776-2:2021
60.60 Standard published
Dec 23, 2021