Standard No.:	YY/T 0688.2-2024
English Name:	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
Chinese Name:	临床实验室检测和体外诊断系统 感染病原体敏感性试验与抗微生物药物敏感性试验设备的性能评价 第2部分：与肉汤微量稀释参考方法比对的抗微生物药物敏感性试验设备性能评价
Professional Classification:	YY    Professional Standard - Pharmaceutics
Source Content Issued by:	National Medical Products Adminstration
Issued on:	2024-09-29
Implemented on:	2025-10-15
Status:	valid
Superseding:	YY/T 0688.2-2010 Clinical laboratory testing and in vitro diagnostic test systems—Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility devices—Part 2:Evaluation of performance of antimicrobial susceptibility test device
Target Language:	English
File Format:	PDF
Word Count:	12500 words
Translation Price(USD):	375.0
Delivery:	via email in 1~5 business day

本文件确立了抗微生物药物敏感性试验（AST）设备的可接受性能标准。
这些设备在医学实验室用于测定细菌对抗微生物药物的最低抑菌浓度（MIC）。
本文件规定了AST设备的要求和评价这些设备性能的程序。本文件提供了如何进行AST设备性能评估。本文件适用于指导制造商进行性能评价研究。