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ISO - FDIS 17822-2

In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Part 2: Laboratory quality practice guide

pending, Most Current
Organization: ISO
Publication Date: 11 August 2020
Status: pending
Page Count: 46
ICS Code (Laboratory medicine in general): 11.100.01
scope:

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.

Document History

FDIS 17822-2
August 11, 2020
In vitro diagnostic test systems — Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens — Part 2: 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...

References

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