ČSN P CEN/TS 17742 (857043)

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Isolated circulating cell free RNA from plasma

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STANDARD published on 1.10.2022


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The information about the standard:

Designation standards: ČSN P CEN/TS 17742
Classification mark: 857043
Catalog number: 515164
Publication date standards: 1.10.2022
SKU: NS-1085271
The number of pages: 28
Approximate weight : 84 g (0.19 lbs)
Country: Czech technical standard
Category: Technical standards ČSN

The category - similar standards:

In vitro diagnostic test systems

Annotation of standard text ČSN P CEN/TS 17742 (857043):

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 17747,1 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

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