UNLIMITED FREE ACCESS TO THE WORLD'S BEST IDEAS

close
Already an Engineering360 user? Log in.

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

Customize Your Engineering360 Experience

close
Privacy Policy

This is embarrasing...

An error occurred while processing the form. Please try again in a few minutes.

ISO FDIS 21474-1

In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation

active, Most Current
Buy Now
Organization: ISO
Publication Date: 11 May 2020
Status: active
Page Count: 30
ICS Code (In vitro diagnostic test systems): 11.100.10
scope:

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".

Document History

ISO FDIS 21474-1
May 11, 2020
In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
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...

References

Advertisement