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

رقم المستند: NL ISO 20776 2 : 2011
القطاع: Health Care Technology
TC: NL TC 212
ICS: 11.100.20
This part of ISO 20776 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 part of ISO 20776 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. This part of ISO 20776 has been developed to guide manufacturers in the conduct of performance evaluation studies.