BS EN ISO 20776-2-2007 临床实验室测试和体外诊断试验系统.传染者的敏感性测试和抗菌剂敏感性试验装置的性能评定.抗菌剂敏感性试验装置的性能评定

标准号：BS 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.传染者的敏感性测试和抗菌剂敏感性试验装置的性能评定.抗菌剂敏感性试验装置的性能评定
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. Evaluation of performance of antimicrobial susceptibility test device
标准类型：C38
发布日期：2007/7/31 12:00:00
实施日期：2007/7/31 12:00:00
中国标准分类号：C38
国际标准分类号：11.100.20
适用范围：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.