DPS
Drejtoria e Përgjithshme e Standardizimit
Tel/Cel: +355 4 222 62 55
E-mail: info@dps.gov.al
Adresa: Rr.: "Reshit Collaku", (pranë ILDKPKI, kati VI), Kutia Postare 98, Tiranë - Shqipëri
Main menu

DS CEN/TS 16826-1:2015

Ekzaminimet molekulare për diagnostikimin in vitro - Specifikime për proceset e para - ekzaminimit për kapjen e indeve të ngrira - Pjesa 1: ARN të izoluara

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 1: Isolated RNA
31 mar 2016
95.99 Withdrawal of Standard   15 pri 2021

General information

95.99     15 pri 2021

DPS

DPS/KT 140

Technical Specification

11.100.10  

anglisht  

Buying

Shfuqizuar

Language in which you want to receive the document.

Scope

This Technical Specification recommends the handling, documentation and processing of frozen tissue specimens intended for RNA analysis during the preanalytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, in vitro diagnostics developers and manufacturers, institutions and commercial organisations performing biomedical research, biobanks, and regulatory authorities).
RNA profiles in tissues can change significantly before and after collection and can change differently in different donors’ / patients’ tissues.
Therefore, special measures have to be taken to minimize the described profile changes and modifications within the tissue for subsequent RNA analysis.
Tissues that have undergone chemical stabilisation pre-treatment before freezing are not covered in this document.

Life cycle

NOW

WITHDRAWN
DS CEN/TS 16826-1:2015
95.99 Withdrawal of Standard
15 pri 2021

REVISED BY

PUBLISHED
SSH EN ISO 20184-1:2018

Related project

Adopted from CEN/TS 16826-1:2015