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  • BSI
    21/30415510 DC BS ISO 21474-2. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Part 2. Validation and verification
    Edition: 2021
    $44.66
    / user per year

Description of 21/30415510 DC 2021

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 of qualitative/quantitative detection of nucleic acid target sequences.

This document is intended as guidance for multiplex examinations 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 diagnostic 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 Number21/30415510 DC
TitleBS ISO 21474-2. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids - Part 2. Validation and verification
StatusDefinitive
Publication Date2021-06-14
Identical National Standard OfISO/DIS 21474-2
DescriptorsNucleic acids, Testing, Tests, Verification, Evaluation
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
PublisherBSI
Pages22

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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