NBN EN ISO 20776-2:2007

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 (ISO 20776-2:2007)

WITHDRAWN

About this standard

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WITHDRAWN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Withdrawn Date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

About this training

Summary

ISO 20776-2:2007 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/ or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. ISO 20776-2:2007 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. ISO 20776-2:2007 has been developed to guide manufacturers in the conduct of performance evaluation studies.