ISO/DIS 21474-3

Тезис

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.

Общая информация

Текущий статус
: В стадии разработки
Версия
: 1
Технический комитет
: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
ICS
:
11.100.10 In vitro diagnostic test systems