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NBN ISO 17822:2021
In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Laboratory quality practice guide
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Summary
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.
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.
Technical characteristics
| Publisher | Bureau de Normalisation Belge (NBN) |
| Publication Date | 06/17/2021 |
| Page Count | 48 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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