ISO 17822:2020 体外诊断试验系统 微生物病原体的检测和鉴定用基于核酸扩增的检验程序 实验室质量实践指南

标准编号：ISO 17822:2020

中文名称：体外诊断试验系统 微生物病原体的检测和鉴定用基于核酸扩增的检验程序 实验室质量实践指南

英文名称：In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide

发布日期：2020-11

标准范围

本文件描述了特定的临床实验室实践要求，以确保使用核酸扩增试验（NAAT）检测、鉴定和量化微生物病原体的质量。它适用于为医疗、研究或健康相关目的开发、实施和使用NAAT或执行NAAT的实验室。本文件不适用于制造商开发体外诊断（IVD）医疗设备。然而，它确实包括实验室实施和使用时对此类设备和/或相应过程的验证和确认。

This document describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT).It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.

标准预览图