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ISO 21474-2:2022

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification
13 maj 2022

General information

60.60     13 maj 2022

ISO

ISO/TC 212

International Standard

11.100.10  

anglisht   frëngjisht  

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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.
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”.

Life cycle

NOW

PUBLISHED
ISO 21474-2:2022
60.60 Standard published
13 maj 2022

National adoptions

Pajisje mjekësore për diagnostikimin in vitro - Testimi molekular i shumëfishtë për acidet nukleike - Pjesa: Vlerësimi dhe verifikimi

60.60 Standard published

DPS/KT 140 më tepër