CEN ISO/TS 5798:2022
体外诊断测试系统-通过核酸扩增法检测严重急性呼吸系统综合症冠状病毒2（SARS-CoV-2）的要求和建议（ISO/TS 5798:2022）

In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods (ISO/TS 5798:2022)

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标准号

CEN ISO/TS 5798:2022

发布

2022年

发布单位

欧洲标准化委员会

当前最新

CEN ISO/TS 5798:2022

 

 

适用范围

This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens. This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics. This document does not apply to environmental samples.

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