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SSH ISO 21474-2:2022

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification

Aug 29, 2023

General information

60.60     Aug 29, 2023

DPS

DPS/KT 140

International Standard

11.100.10  

English  

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Scope

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.

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PUBLISHED
SSH ISO 21474-2:2022
60.60 Standard published
Aug 29, 2023