Standard ÖNORM EN ISO 20776-2 1.5.2022 preview

ÖNORM EN ISO 20776-2

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)

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STANDARD published on 1.5.2022


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The information about the standard:

Designation standards: ÖNORM EN ISO 20776-2
Publication date standards: 1.5.2022
SKU: NS-1055267
The number of pages: 26
Approximate weight : 78 g (0.17 lbs)
Country: Austrian technische Norm
Category: Technical standards ÖNORM

The category - similar standards:

Biological evaluation of medical devices

Annotation of standard text ÖNORM EN ISO 20776-2 :

Dieses Dokument legt annehmbare Leistungskriterien für Testsysteme zur Prüfung der mikrobiellen Empfindlichkeit (AST, en: antimicrobial susceptibility test) fest, die zur Bestimmung der minimalen Hemmkonzentrationen (MHK) von Bakterien auf antimikrobielle Substanzen in medizinischen Laboren verwendet werden. Dieses Dokument legt Anforderungen an Testsysteme zur Prüfung der mikrobiellen Empfindlichkeit sowie Verfahren zur Leistungsbewertung dieser Testsysteme fest. Es legt fest, wie eine Leistungsbewertung eines Testsystems zur Prüfung der mikrobiellen Empfindlichkeit durchzuführen ist. Dieses Dokument wurde mit dem Ziel erarbeitet, Hersteller bei der Durchführung von Leistungsbewertungsstudien anzuleiten.

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