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STANDARD

Current

ÖNORM EN ISO 11781

Issue date: 2025 07 15

Molecular biomarker analysis - Requirements and guidance for single-laboratory validation of qualitative real-time polymerase chain reaction (PCR) methods (ISO 11781:2025)

This document specifies minimum requirements and minimum performance criteria for conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied to the detection of specific DNA sequences present in foods. The document is applicable to any single-laboratory validation of a qualitative real-time PCR method used for the detection of specific DNA sequences in food and food products (e.g. for the detection of genetically modified foodstuffs and for species determination, including species known to produce allergenic proteins). The document does not apply to single laboratory validation of qualitative microbiological real-time PCR methods. The document does not apply to the evaluation of applicability and practicability with respect to the specific scope of the PCR method.

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General information on ÖNORM EN ISO 11781

Format

Paper | 31 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 205 Food and animal feeding stuffs analysis

Timeline

An overview of the development of ÖNORM EN ISO 11781 from 2019 til today.

• ÖNORM EN ISO 11781

  2025 07 15 Standard ÖNORM EN ISO 11781, Edition: 2025 07 15

  Molecular biomarker analysis - Requirements and guidance for single-laboratory validation of qualita...
• ONR CEN/TS 17329-1

  2021 09 15 Technische Regel ONR CEN/TS 17329-1, Edition: 2021 09 15

  Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 1: Si...
• ONR CEN/TS 17329-1

  2019 08 01 Technische Regel ONR CEN/TS 17329-1, Edition: 2019 08 01

  Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 1: Si...

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Frequently Asked Questions about ÖNORM EN ISO 11781

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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 16577:2016	Titel Molecular biomarker analysis — Terms and definitions	Ausgabedatum 2016 03 16	Art Standard	Zur Produktseite
Dokumentnummer ISO 21571:2005	Titel Foodstuffs — Methods of analysis for the detection of genetically modified organisms and derived products — Nucleic acid extraction	Ausgabedatum 2005 03 02	Art Standard	Zur Produktseite

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