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

ISO 17822E:2020

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

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.

This document is available in electronic format only.

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Details

Date of Publication: November 1, 2020

Order Code PDF: ISO17822E

Order Code Print: print not available

Edition: First

Pages: 39

ISO 17822E:2020 Additional Details

Technical Committee : ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.