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  • BSI
    BS ISO 21474-1:2020 In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Terminology and general requirements for nucleic acid quality evaluation
    Edition: 2020
    $411.69
    / user per year

Description of BS ISO 21474-1:2020 2020

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”.



Standard NumberBS ISO 21474-1:2020
TitleIn vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Terminology and general requirements for nucleic acid quality evaluation
StatusDefinitive
Publication Date2020-08-24
Identical National Standard OfISO 21474-1:2020
DescriptorsQuality, Evaluation, Terminology, Testing, Nucleic acids
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 580 98656 7
PublisherBSI
Pages32

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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