ISO 20776-2:2021 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

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

本文件为用于确定医学实验室中细菌对抗菌剂的最低抑制浓度（MIC）的抗菌药物敏感性试验（AST）设备建立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。本文件旨在指导制造商进行性能评估研究。

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.

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