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STANDARD

Current

ÖNORM EN ISO 20184-3

Issue date: 2021 11 15

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue - Part 3: Isolated DNA (ISO 20184-3:2021)

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.

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General information on ÖNORM EN ISO 20184-3

Format

Paper | 23 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 179 Medical technology

Timeline

An overview of the development of ÖNORM EN ISO 20184-3 from 2018 til today.

• ÖNORM EN ISO 20184-3

  2021 11 15 Standard ÖNORM EN ISO 20184-3, Edition: 2021 11 15

  Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen...
• ONR CEN/TS 16826-3

  2018 10 15 Technische Regel ONR CEN/TS 16826-3, Edition: 2018 10 15

  Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for snap f...

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Frequently Asked Questions about ÖNORM EN ISO 20184-3

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 15189:2012	Titel Medical laboratories — Requirements for quality and competence	Ausgabedatum 2012 11 05	Art Standard	Zur Produktseite
Dokumentnummer ISO 15190:2020	Titel Medical laboratories — Requirements for safety	Ausgabedatum 2020 02 24	Art Standard	Zur Produktseite

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