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SRPS CEN ISO/TS 5798:2023

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)

Mar 30, 2023

General information

60.60     Mar 30, 2023

ISS

Z076

Technical Specification

11.100.01  

English  

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Scope

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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PUBLISHED
SRPS CEN ISO/TS 5798:2023
60.60 Standard published
Mar 30, 2023

Related project

Adopted from CEN ISO/TS 5798:2022 IDENTICAL

Adopted from ISO/TS 5798:2022 IDENTICAL