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

The information about the standard:

Designation standards: ČSN P CEN ISO/TS 5798
Classification mark: 857045
Catalog number: 516700
Publication date standards: 1.5.2023
The number of pages: 60
Approximate weight : 180 g (0.40 lbs)
Country: Czech technical standard
Kategorie: Technische Normen ČSN

Annotation of standard text ČSN P CEN ISO/TS 5798 (857045):

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