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STANDARD

Current

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 (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.

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General information on ÖNORM EN ISO 20776-2

Format

Paper | 26 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 20776-2 from 2007 til today.

• ÖNORM EN ISO 20776-2

  2022 05 01 Standard ÖNORM EN ISO 20776-2, Edition: 2022 05 01

  Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infecti...
• ÖNORM EN ISO 20776-2

  2007 10 01 Standard ÖNORM EN ISO 20776-2, Edition: 2007 10 01

  Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infecti...

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Frequently Asked Questions about ÖNORM EN ISO 20776-2

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 20776-1:2019	Titel 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)	Ausgabedatum 2019 06 05	Art Standard	Zur Produktseite

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