Aktívna norma | Vydaná: 01.12.2020

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
(Systemes d´essai pour diagnostic in vitro — Modes opératoires d´examen in vitro qualitatifs fondés sur l´acide nucléique pour la détection et l´identification d´agents pathogenes microbiens — Guide pratique sur la qualité dans les laboratoires)

Dostupné jazyky: Anglicky

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Podrobné informácie

Označenie: ISO 17822:2020

Dátum vydania: 01.12.2020

Stránok: 39

Krajina: Medzinárodná technická norma

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Anotácia

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.

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