DIN EN ISO 20776-2-2007 临床实验室测试和体外诊断试验系统.传染者的易感性测试和抗菌剂易感性试验装置的性能评估.第2部分:抗菌剂易感性试验装置的性能评估(ISO 20776-2:

标准号：DIN EN ISO 20776-2-2007
中文标准名称：临床实验室测试和体外诊断试验系统.传染者的易感性测试和抗菌剂易感性试验装置的性能评估.第2部分:抗菌剂易感性试验装置的性能评估(ISO 20776-2:2007)
英文标准名称：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: Evaluation of performance of antimicrobial susceptibility t
标准类型：C04
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C04
国际标准分类号：11.100.10
引用标准：ISO 20776-1
适用范围：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 categorydeterminations of susceptible, intermediate and resistant (SIR) strains of bacteria to antimicrobial agents inmedical laboratories. This part of ISO 20776 specifies requirements for AST devices (including diffusion testsystems) and procedures for assessing Performance of such devices. It defines how a Performance evaluationof an AST device is to be conducted. This part of ISO 20776 has been developed to guide manufacturers inthe conduct of performance evaluation studies.