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ISO 17822:2020

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

Publication date:   Dec 1, 2020

General information

60.60 Standard published   Dec 1, 2020

ISO

ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems

International Standard

11.100.01   Laboratory medicine in general

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Scope

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.

Life cycle

PREVIOUSLY

WITHDRAWN
ISO/TS 17822-1:2014

NOW

PUBLISHED
ISO 17822:2020
60.60 Standard published
Dec 1, 2020