Draft International Standard
ISO/DIS 21474-3
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 3: Interpretation and reports
Reference number
ISO/DIS 21474-3
ISO/DIS 21474-3
Edición 1
© ISO 2024
Draft
International Standardu
ISO/DIS 21474-3
83565
No disponible en español
Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.
Resumen
This document gives general requirements for interpretation and reports of multiplex molecular tests using IVD medical devices and laboratory developed tests (LDTs), including qualitative/quantitative detection of nucleic acid targets. This document is applicable to all the methods that are used for IVD medical devices and LDTs that measure two or more nucleic acid targets of interest. This document is intended for multiplex assays that evaluate human nucleic acid targets, and detection of microbial pathogens in the background of human genome directly from clinical specimens.
Informaciones generales
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Estado: En desarrolloEtapa: Informe completo distribuido: DIS aprobado para su registro como FDIS [40.99]
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Edición: 1Número de páginas: 14
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Comité Técnico :ISO/TC 212ICS :11.100.10
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