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Résumé Preview

This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences.

This document is intended as guidance for multiplex molecular assays that detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to metagenomics.

NOTE An examination procedure developed for a laboratory's own use is often referred to as a "laboratory developed test", "LDT", or "in-house test".


Informations générales

  • État actuel :  Publiée
    Date de publication : 2020-08
  • Edition : 1
  • :
    ISO/TC 212
    Laboratoires d'analyses de biologie médicale et systèmes de diagnostic in vitro
  • 11.100.10
    Systèmes de diagnostic in vitro

Acheter cette norme

Format Langue
PDF + ePub
Papier
  • CHF118

Cycle de vie

Les normes ISO sont réexaminées tous les cinq ans



Révision / Rectificatifs techniques

  • Actuellement
    ISO 21474-1:2020

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