Standard Number: YY/T 0688.2-2010(YY/T0688.2-2010)
Chinese: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菌剂敏感性试验设备的性能评价 第2部分：抗菌剂敏感性试验设备的性能评价
English: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 devices
Effective Date:2012-06-01
ICS:11.000
Standard Applicability:This part of YY/T 0688 establishes acceptable performance standards for antimicrobial susceptibility testing (AST) equipment. These devices are used in medical laboratories to determine the minimum inhibitory concentration (MIC) of an antimicrobial agent on bacteria and/or to determine the interpretive classification of bacteria as susceptible, intermediary, and resistant (SIR) to an antimicrobial agent. This part specifies requirements for AST equipment, including diffusion test systems, and procedures for evaluating the performance of such equipment. The standard defines how AST equipment performance evaluations are conducted. This part is used to guide manufacturers in performance evaluation studies.
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