Back

CEN/TS 17688-1:2021

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for Fine Needle Aspirates (FNAs) - Part 1: Isolated cellular RNA

General information
Valid from 31.12.2021
Base Documents
CEN/TS 17688-1:2021
Directives or regulations
None
Standard history
Status
Date
Type
Name
31.12.2021
Main
This document gives guidelines on the handling, documentation, storage and processing of fine needle aspirates (FNAs) intended for RNA examination during the pre-examination phase before a molecular examination is performed. This document is applicable to molecular in vitro diagnostic examination including laboratory developed tests performed by medical laboratories and molecular pathology laboratories that examine RNA isolated from FNAs. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organisations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for collecting, stabilizing, transporting and storing of core needle biopsies (FNA Biopsy or FNA B) and are not covered in this document, but in EN ISO 20184-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 1: Isolated RNA and EN ISO 20166-1, Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin fixed and paraffin-embedded (FFPE) tissue - Part 1: Isolated RNA. This document is not applicable for RNA examination by in situ detection. NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.
*
*
*
PDF
18.48 € incl tax
Paper
18.48 € incl tax
Browse a standard: 2.40 € incl tax
Standard monitoring