NBN EN ISO 20776-2:2022

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)

ACTIVE

About this standard

Languages
German, English and French
Type
NBN
Standards committee
CEN/TC 140
Status
ACTIVE
Publication date
22 January 2022
Replaces
NBN EN ISO 20776-2:2007
ICS Code
11.100.20 (Biological evaluation of medical devices)
Withdrawn Date

About this training

Summary

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.