Reference number
ISO/TS 5798:2022
ISO/TS 5798:2022
© ISO 2024
Technical Specification
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
Edition 1
2022-04
2022-04
Technical Specification
Resumen
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.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2022-04Etapa: Norma Internacional publicada [60.60]
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Edición: 1Número de páginas: 44
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Comité Técnico :ISO/TC 212ICS :11.100.01
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