ISO 20776-2E 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
This international standard 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.
This document is available in electronic format only.
Date of Publication: July 1, 2007
Order Code PDF: ISO207762E
Order Code Print: print not available
ISO 20776-2:2007 Additional Details
The document specifies requirements for AST devices (including diffusion test systems) and procedures for assessing the performance of such devices. It defines how a performance evaluation of an AST device is to be conducted and has been developed to guide manufacturers in the conduct of performance evaluation studies.
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Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems