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

本文件给出了同时识别两个或多个相关核酸靶序列的多重分子测试的验证和验证的一般要求。本文件适用于使用IVD医疗设备和实验室开发测试（LDT）进行检查的所有多重方法。它为核酸靶序列的定性和定量检测提供了信息。本文件旨在为检测和/或量化人类临床标本中的人类核酸靶序列或微生物病原体核酸靶序列的多重检查提供指导。本文件适用于医学实验室进行的任何分子体外诊断（IVD）检查。它也适用于实验室客户、IVD开发人员和制造商、生物银行、机构和从事生物医学研究的商业组织以及监管机构。本文件不适用于宏基因组学。注意为实验室自身使用而开发的检查程序通常被称为“实验室开发测试”、“LDT”或“内部测试”。

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.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”.

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