10.20 7 gush 2021
ISO
ISO/TC 212
International Standard
This document gives general requirements for interpretation and reports of multiplex molecular tests using IVD medical devices and laboratory developed tests (LDTs), including qualitative/quantitative detection of nucleic acid targets.
This document is applicable to all the methods that are used for IVD medical devices and LDTs that measure two or more nucleic acid targets of interest. This document is intended for multiplex assays that evaluate human nucleic acid targets, and detection of microbial pathogens in the background of human genome directly from clinical specimens.
IN_DEVELOPMENT
ISO/NP 21474-3
10.20
New project ballot initiated
7 gush 2021
Only informative sections of projects are publicly available. To view the full content, you will need to members of the committee. If you are a member, please log in to your account by clicking on the "Log in" button.