标准编号：ISO 20776-2:2021
中文名称：临床实验室试验和体外诊断试验系统 传染源的敏感性试验和抗生素敏感性试验装置性能的评估 第2部分：抗生素敏感性试验装置对参考肉汤微稀释实验室的性能评估
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：2021-12
标准范围
This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories.
This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted.
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