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ISO 17822:2020

Current
Current

The latest, up-to-date edition.

In vitro diagnostic test systems Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Laboratory quality practice guide
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

12-01-2020

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.

DocumentType
Standard
Pages
39
ProductNote
THIS STANDARD ALSO REFERS TO :CLSI, MM03, CLSI MM06, JCCLS MM5-A1, JCGM 200, ISO 11843, CLSI MM07-A2, CLSI MM17-A2
PublisherName
International Organization for Standardization
Status
Current
Supersedes

Standards Relationship
IS 18131 : 2023 Identical
UNI ISO 17822:2023 Identical
BS ISO 17822:2020 Identical

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