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
Reference number
ISO 20776-2:2021
Edition 2
2021-12
International Standard
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ISO 20776-2:2021
79377
Published (Edition 2, 2021)

ISO 20776-2:2021

ISO 20776-2:2021
79377
Language
Format
CHF 96
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Abstract

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.

General information

  •  : Published
     : 2021-12
    : International Standard published [60.60]
  •  : 2
     : 16
  • ISO/TC 212
    11.100.20 
  • RSS updates

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