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)
临床实验室检测和体外诊断试验系统 - 感染性试剂的敏感性检测和抗菌药敏试验装置的性能评估 - 第2部分:抗菌药敏试验装置的性能评估(ISO 20776-2:2007)
发布日期:
2007-07-01
ISO 20776-2:2007为抗微生物药敏试验(AST)装置确定了可接受的性能标准,用于确定细菌对抗微生物剂的敏感,中间和抗性(SIR)菌株的最小抑菌浓度(MIC)和/或解释类别测定在医学实验室。 ISO 20776-2:2007规定了AST设备(包括扩散测试系统)和评估这些设备性能的程序的要求。它定义了如何进行AST设备的性能评估。 ISO 20776-2:2007已经开发,以引导制造商进行绩效评估研究
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.