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CEN 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) CEN ISO/TS 5798:2022

Publication date:   Jan 17, 2023

General information

60.60   Standard published   Nov 30, 2022

CEN

CEN/TC 140 In vitro diagnostic medical devices

Technical Specification

11.100.01   Laboratory medicine in general

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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.

Life cycle

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PUBLISHED
CEN ISO/TS 5798:2022
60.60 Standard published
Nov 30, 2022

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Adopted from ISO/TS 5798:2022 IDENTICAL




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