标准摘要
[中文适用范围]： 本文件为用于确定医学实验室中细菌对抗菌药物的最低抑菌浓度 (MIC) 的抗菌药敏测试 (AST) 装置制定了可接受的性能标准。 本文件规定了 AST 设备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。 本文件的制定是为了指导制造商进行性能评估研究。 [外文原描述]： 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. This document has been developed to guide manufacturers in the conduct of performance evaluation studies.
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: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution