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Glavni meni

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
19. 4. 2022.

Опште информације

90.60     3. 9. 2025.

ISO

ISO/TC 212

Tehnička specifikacija

11.100.01  

engleski   francuski  

Kupovina

Objavljen

Jezik na kome želite da primite dokument.

Apstrakt

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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO/TS 5798:2022
90.60 Završetak postupka preispitivanja standarda
3. 9. 2025.

Nacionalna preuzimanja

SRPS CEN ISO/TS 5798:2023  
ISS

In vitro dijagnostički sistemi ispitivanja – Zahtevi i preporuke za otkrivanje teškog akutnog respiratornog sindroma koronavirusa 2 (SARS COV-2) metodama amplifikacije nukleinske kiseline

60.60   Standard objavljen

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