CEN/TS 16826-3:2018

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap frozen tissue - Part 3: Isolated DNA

Publication date:   Oct 17, 2018

General information

99.60 Withdrawal effective   May 26, 2021

CEN

CEN/TC 140 In vitro diagnostic medical devices

Technical Specification

11.100.10   In vitro diagnostic test systems

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Scope

This document gives recommendations for the handling, storage, processing and documentation of frozen tissue specimens intended for DNA 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 evaluate DNA isolated from frozen tissue. 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.
Tissues that have undergone chemical stabilization pre-treatment before freezing are not covered in this document.
NOTE International, national or regional regulations or requirements can also apply to specific topics covered in this document.

Life cycle

NOW

WITHDRAWN
CEN/TS 16826-3:2018
99.60 Withdrawal effective
May 26, 2021

REVISED BY

PUBLISHED
EN ISO 20184-3:2021