SRPS EN ISO 20776-2:2008

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)

Scope

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.