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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
Translate name
STANDARD published on 1.12.2020
The information about the standard:
Designation standards: ISO 17822:2020
Publication date standards: 1.12.2020
SKU: NS-1012068
The number of pages: 39
Approximate weight : 117 g (0.26 lbs)
Country: International technical standard
Category: Technical standards ISO
The category - similar standards:
Annotation of standard text ISO 17822:2020 :
Description / 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.
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