標準號：BS EN ISO 20776-2-2007
中文標準名稱：臨床實驗室測試和體外診斷試驗系統(tǒng).傳染者的敏感性測試和抗菌劑敏感性試驗裝置的性能評定.抗菌劑敏感性試驗裝置的性能評定
英文標準名稱：Clinical laboratory testing and in vitro diagnostic test systems. Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices. Evaluation of performance of antimicrobial susceptibility test device
標準類型：C38
發(fā)布日期：2007/7/31 12:00:00
實施日期：2007/7/31 12:00:00
中國標準分類號：C38
國際標準分類號：11.100.20
適用范圍：ISO 20776-2:2007 establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) and/or interpretive category determinations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents in medical laboratories. ISO 20776-2:2007 specifies requirements for AST devices (including diffusion test systems) and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. ISO 20776-2:2007 has been developed to guide manufacturers in the conduct of performance evaluation studies.