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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 (Corrected version 2020-12)

General information
Valid from 01.12.2020
Directives or regulations
None
Standard history
Status
Date
Type
Name
01.12.2020
Main
09.12.2014
Main
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.
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Standard monitoring