International Standard
ISO 20184-3:2021
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
Reference number
ISO 20184-3:2021
Edition 1
2021-05
International Standard
Read sample
ISO 20184-3:2021
78110
Published (Edition 1, 2021)

ISO 20184-3:2021

ISO 20184-3:2021
78110
Language
Format
CHF 96
Convert Swiss francs (CHF) to your currency

Abstract

This document specifies requirements and 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 examinations 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.

General information

  •  : Published
     : 2021-05
    : International Standard published [60.60]
  •  : 1
     : 15
  • ISO/TC 212
    11.100.10 
  • RSS updates

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)