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STANDARD

Current

ÖNORM EN ISO 4307

Issue date: 2022 02 15

Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva - Isolated human DNA (ISO 4307:2021)

This document specifies requirements and recommendations on the handling, storage, processing and documentation of saliva specimens intended for human 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. It can also be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Dedicated measures that need to be taken for saliva collected on absorbing material or by mouth washes are not described in this document. Neither are measures for preserving and handling of native saliva cell-free DNA, pathogens, and other bacterial or whole microbiome DNA in saliva described.

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General information on ÖNORM EN ISO 4307

Format

Digital | 21 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 4307 from 2019 til today.

• ÖNORM EN ISO 4307

  2022 02 15 Standard ÖNORM EN ISO 4307, Edition: 2022 02 15

  Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for saliva...
• ONR CEN/TS 17305

  2019 08 01 Technische Regel ONR CEN/TS 17305, Edition: 2019 08 01

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

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Frequently Asked Questions about ÖNORM EN ISO 4307

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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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