International Standard
ISO 21474-2:2022
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
Reference number
ISO 21474-2:2022
Edition 1
2022-05
International Standard
Read sample
ISO 21474-2:2022
78024
Published (Edition 1, 2022)

ISO 21474-2:2022

ISO 21474-2:2022
78024
Language
Format
CHF 96
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Abstract

This document gives the general requirements for validation and verification of multiplex molecular tests which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex methods used for examination using 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 examinations that either 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 (IVD) examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD 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”.

General information

  •  : Published
     : 2022-05
    : International Standard published [60.60]
  •  : 1
     : 15
  • ISO/TC 212
    11.100.10 
  • RSS updates

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