Systémy diagnostických zkoušek in vitro - Požadavky a doporučení pro detekci koronaviru 2 (SARS-CoV-2) způsobujícího těžký akutní respirační syndrom metodami amplifikace nukleových kyselin (Norma k přímému použití jako ČSN).
NORMA vydána dne 1.5.2023
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: Technické normy ČSN
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