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  • BSI
    BS 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
    Edition: 2021
    $500.66
    / user per year

Description of BS ISO 17822:2020 2021

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.



Standard NumberBS ISO 17822:2020
TitleIn vitro diagnostic test systems. Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens. Laboratory quality practice guide
StatusDefinitive
Publication Date2021-01-29
ReplacesPD ISO/TS 17822-1:2014
Identical National Standard OfISO 17822:2020
CorrectsBS ISO 17822:2020
DescriptorsTerminology, Medical inspection, Properties, Definitions, Vocabulary, Diagnostic testing, Pathogens, Nucleic acids
ICS11.100.01 Laboratory medicine in general, 01.040.19 Testing (Vocabularies)
CommitteeCH/212
ISBN978 0 539 16842 6
PublisherBSI
Pages48

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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