ISO 20776-2:2007 临床实验室测试和体外诊断试验系统 传染剂的易感性测试和抗菌剂易感性测试设备的性能评估 第2部分：抗菌剂易感性测试设备的性能评估

标准编号：ISO 20776-2:2007

中文名称：临床实验室测试和体外诊断试验系统 传染剂的易感性测试和抗菌剂易感性测试设备的性能评估 第2部分：抗菌剂易感性测试设备的性能评估

英文名称：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: Eval

发布日期：2007-07

标准范围

ISO 20776-2:2007为抗生素敏感性试验（AST）设备建立了可接受的性能标准，这些设备用于确定医学实验室中对抗生素敏感、中间和耐药（SIR）菌株的最低抑菌浓度（MIC）和/或解释性类别测定。ISO 20776-2:2007规定了AST设备（包括扩散测试系统）的要求以及评估此类设备性能的程序。它定义了如何对AST设备进行性能评估。ISO 20776-2:2007旨在指导制造商进行性能评估研究。

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.

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