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  • BSI
    PD CEN/TS 17742:2022 Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma
    Edition: 2022
    $411.69
    / user per year

Description of PD CEN/TS 17742:2022 2022

This document specifies requirements and recommendations for the pre-examination phase of circulating cell free RNA (ccfRNA) from venous whole blood specimens, including but not limited to the collection, handling, storage, processing and documentation of venous whole blood specimens intended for ccfRNA examination. This document covers specimens collected in venous whole blood collection tubes. The pre-examination process described in this document results in circulating cell free RNA isolated from blood plasma without prior enrichment of exosomes and other extracellular vesicles. This document is applicable to molecular in vitro diagnostic examinations performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures need to be taken during the pre-examination phase for isolated RNA from enriched exosomes and other extracellular vesicles enriched from venous whole blood and for cellular RNA isolated from venous whole blood. These are not described in this document but are covered in CEN/TS 17747, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for exosomes and other extracellular vesicles in venous whole blood - Isolated DNA, RNA and proteins, and in EN ISO 20186 1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Standard NumberPD CEN/TS 17742:2022
TitleMolecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood. Isolated circulating cell free RNA from plasma
StatusDefinitive
Publication Date2022-05-11
Identical National Standard OfCEN/TS xxx
DescriptorsDiagnostic equipment (medical), Diagnostic instruments (medical), Laboratory equipment, Testing, Diagnostic testing
ICS11.100.10 In vitro diagnostic test systems
CommitteeCH/212
ISBN978 0 539 06274 8
PublisherBSI
Pages28

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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