標(biāo)準(zhǔn)號：ISO 20776-2-2007
中文標(biāo)準(zhǔn)名稱：臨床實驗室測試和體外診斷試驗系統(tǒng).傳染者的易感性測試和抗菌劑易感性試驗裝置的性能評估.第2部分:抗菌劑易感性試驗裝置的性能評估
英文標(biāo)準(zhǔn)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 - Part 2: Evaluation of performance of antimicrobial susceptibility t
標(biāo)準(zhǔn)類型：C04
發(fā)布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標(biāo)準(zhǔn)分類號：C04
國際標(biāo)準(zhǔn)分類號：11.100.20
適用范圍：This part of ISO 20776 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. This part of ISO 20776 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. This part of ISO 20776 has been developed to guide manufacturers in the conduct of performance evaluation studies.