Reference number
ISO 20776-2:2021
© ISO 2024
International Standard
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
Edition 2
2021-12
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Publicado (Edición 2, 2021)

ISO 20776-2:2021

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Formato
CHF 96
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Resumen

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.

Informaciones generales

  • Estado
     : Publicado
    Fecha de publicación
     : 2021-12
    Etapa
    : Norma Internacional publicada [60.60]
  • Edición
     : 2
    Número de páginas
     : 16
  • Comité Técnico :
    ISO/TC 212
    ICS :
    11.100.20 
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