In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide
NORM herausgegeben am 1.12.2020
Bezeichnung normen: ISO 17822:2020
Ausgabedatum normen: 1.12.2020
Zahl der Seiten: 39
Gewicht ca.: 117 g (0.26 Pfund)
Land: Internationale technische Norm
Kategorie: Technische Normen ISO
Description / Abstract: 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.