19/30361173 DC - BS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids. Part 1. Terminology and general requirements for nucleic acid quality evaluation

19/30361173 DC

BS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids. Part 1. Terminology and general requirements for nucleic acid quality evaluation

Status : Current, Draft for public comment   Published : August 2019

Format
PDF

Format
HARDCOPY



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 Number19/30361173 DC
TitleBS ISO 21474. In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids. Part 1. Terminology and general requirements for nucleic acid quality evaluation
StatusCurrent, Draft for public comment
Publication Date29 August 2019
Normative References(Required to achieve compliance to this standard)ISO 15189:2012
Informative References(Provided for Information)ISO/FDIS 20395, ISO 9000, ISO 20166, ISO 3534-1, ISO 24276:2006/Amd.1:2013, ISO 18113-1, ISO/IEC Guide 99, ISO/IEC 17043, ISO/TS 20658, ISO 20186, ISO 20184, ISO 22174:2005, ISO 16578:2013, ISO 16577:2016, ISO 20837:2006
International RelationshipsISO/DIS 21474-1
Draft Expiry Date14 October 2019
DescriptorsQuality, Evaluation, Terminology, Testing, Nucleic acids
ICS11.100.10
Title in FrenchDispositifs médicaux de diagnostic in vitro — Tests moléculaires multiplex pour les acides nucléiques — Partie 1: Terminologie et exigences générales pour l’évaluation de la qualité des acides nucléiques
CommitteeCH/212
PublisherBSI
FormatA4
DeliveryYes
Pages28
File Size442 KB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents


BSOL

The faster, easier way to work with standards


Collaborate, Innovate, Accelerate.


Worldwide Standards
We can source any standard from anywhere in the world