International Standard
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
Reference number
ISO 17822:2020
Edition 1
2020-11
© ISO 2024
International Standard
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Published (Edition 1, 2020)

ISO 17822:2020

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CHF 173
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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.

General information

  • Status
     : Published
    Publication date
     : 2020-11
    Corrected version (en)
     : 2020-12
    Stage
    : International Standard published [60.60]
  • Edition
     : 1
    Number of pages
     : 39
  • Technical Committee :
    ISO/TC 212
    ICS :
    11.100.01 
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

3
Good Health and Well-being

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