EN ISO 20776-2:2022
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

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

EN ISO 20776-2:2022 发布历史

This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories. This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. This document has been developed to guide manufacturers in the conduct of performance evaluation studies.

EN ISO 20776-2:2022由欧洲标准化委员会 IX-CEN 发布于 2022-01-19，并于 2022-04-30 实施，于 2025-01-31 废止。

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EN ISO 20776-2:2022的历代版本如下：

• 2022年 EN ISO 20776-2:2022 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
• 2007年 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

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标准号

EN ISO 20776-2:2022

发布

2022年

发布单位

欧洲标准化委员会

当前最新

EN ISO 20776-2:2022

 

 

适用范围

This document establishes acceptable performance criteria for antimicrobial susceptibility test (AST) devices that are used to determine minimum inhibitory concentrations (MIC) of bacteria to antimicrobial agents in medical laboratories. This document specifies requirements for AST devices and procedures for assessing performance of such devices. It defines how a performance evaluation of an AST device is to be conducted. This document has been developed to guide manufacturers in the conduct of performance evaluation studies.

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