Standard

ISO/TS 5798:2022

Apr 2022 Historical draft

Note: This standard has a new edition: ISO/TS 5798:2022

Corrigenda and amendments are bought separately.

Language English

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Abstract

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.

Document information

Standard from ISO
Published: 19 April 2022
Edition: 1
Version: 1
Document type: TS
ISBN:

ICS 11.100.01
ISO TC ISO/TC 212

ISO/TS 5798:2022

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ISO/TS 5798:2022

ISO/TS 5798:2022

Abstract

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ISO/TS 5798:2022

ISO/TS 5798:2022

Abstract

Document information