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

The information about the standard:

Designation standards: ČSN EN ISO 20776-2-ed.2
Classification mark: 857006
Catalog number: 514794
Publication date standards: 1.8.2022
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

Annotation of standard text ČSN EN ISO 20776-2-ed.2 (857006):

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