ISO 21474-2:2022 体外诊断医疗器械 核酸的多重分子测试 第2部分：验证和验证

标准编号：ISO 21474-2:2022

中文名称：体外诊断医疗器械 核酸的多重分子测试 第2部分：验证和验证

英文名称：In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 2: Validation and verification

发布日期：2022-05

标准范围

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 qualitative and quantitative detection of nucleic acid target sequences. This document is intended as guidance for multiplex examinations that either 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 (IVD) examination performed by medical laboratories. It is also intended to be used by laboratory customers, IVD developers and manufacturers, biobanks, institutions, and commercial organizations performing biomedical research and regulatory authorities. This document is not applicable to metagenomics.

标准预览图