DIN EN ISO 20166-1:2019 Edition

$38.35

Molecular in vitro diagnostic examinations – Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue – Part 1: Isolated RNA

Published By	Publication Date	Number of Pages
DIN	2019-04	30

Guaranteed Safe Checkout

Categories: 11.100.10 - In vitro diagnostic test systems, DIN

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

Description

This International Standard recommends the handling, documentation, storage and processing of formalin fixed and paraffin embedded (FFPE) tissue specimens intended for RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories and molecular pathology laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities. The formalin fixation and the paraffin embedding process lead to modifications of the RNA molecules, which can impact the validity and reliability of the examination test results. RNA profiles in tissues can change drastically during collection and change differently in different tissue donors' / patients' tissues. Therefore, it is essential to take special measures to minimize the described RNA profile changes and modifications within the tissue for subsequent examination.

Additional information

Published Code	DIN
Published By	Deutsches Institut für Normung
Publication Date	2019-04
Pages Count	30
Language	Germany
Descriptors	Biomedical, Definitions, Insulated, Investigations, In-vitro diagnostic, Laboratories, Laboratory medicine, Medical sciences, Medical technology, Methods of analysis, Molecular structure, Ribonucleic acid, Samples, Specification (approval), Specimens, Storage, Test materials, Tissue, Bearings, Fabrics, Netting
File Size	1.3 MB
ICS Codes	11.100.10 - In vitro diagnostic test systems

Preview PDF


PDF Format	Searchable	Printable	Preview Now

DIN EN ISO 20166-1:2019 Edition

Related products