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CEN

prEN ISO 11781

(Main)

Molecular biomarker analysis - General guidelines for single-laboratory validation of qualitative real-time PCR methods (ISO/DIS 11781:2023)

Molecular biomarker analysis - General guidelines for single-laboratory validation of qualitative real-time PCR methods (ISO/DIS 11781:2023)

This document describes the performance characteristics and minimum performance criteria which should be taken into account when conducting a single-laboratory validation study for qualitative (binary) real-time polymerase chain reaction (PCR) methods applied for the detection of specific DNA sequences present in foods.
The protocol was developed for qualitative real-time PCR methods for the detection of DNA sequences derived from genetically modified foodstuffs. It is applicable also for single-laboratory validation of qualitative PCR methods used for analysis of other food materials, e.g. for species detection and identification.
The document does not cover the evaluation of the applicability and the practicability with respect to the specific scope of the PCR method.

Molekulare Biomarker-Analyse - Allgemeine Anleitung für die Einzellaborvalidierung qualitativer Real-time-PCR Verfahren (ISO/DIS 11781:2023)

Analyse de biomarqueurs moléculaires - Lignes directrices générales pour la validation intralaboratoire des méthodes de PCR qualitative en temps réel (ISO/DIS 11781:2023)

Analiza molekulskih biomarkerjev - Splošne smernice za validacijo kvalitativnih metod PCR v realnem času v posameznem laboratoriju (ISO/DIS 11781:2023)

General Information

Status
Not Published
Publication Date
23-Jun-2025
ICS
67.050 - General methods of tests and analysis for food products
Technical Committee
CEN/TC 275 - Food analysis - Horizontal methods
Drafting Committee
CEN/TC 275/WG 11 - Genetically modified foodstuffs
Current Stage
4060 - Closure of enquiry - Enquiry
Start Date
21-Feb-2024
Completion Date
21-Feb-2024
Ref Project
oSIST prEN ISO 11781:2024 - Molecular biomarker analysis - General guidelines for single-laboratory validation of qualitative real-time PCR methods (ISO/DIS 11781:2023)

Relations

Revises
CEN/TS 17329-1:2021 - Foodstuffs - General guidelines for the validation of qualitative real-time PCR methods - Part 1: Single-laboratory validation
Effective Date
20-Apr-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 11781:2024
01-februar-2024
Analiza molekulskih biomarkerjev - Splošne smernice za validacijo kvalitativnih
metod PCR v realnem času v posameznem laboratoriju (ISO/DIS 11781:2023)
Molecular biomarker analysis - General guidelines for single-laboratory validation of
qualitative real-time PCR methods (ISO/DIS 11781:2023)
Molekulare Biomarker-Analyse - Allgemeine Anleitung für die Einzellaborvalidierung
qualitativer Real-time-PCR Verfahren (ISO/DIS 11781:2023)
Analyse de biomarqueurs moléculaires - Lignes directrices générales pour la validation
intralaboratoire des méthodes de PCR qualitative en temps réel (ISO/DIS 11781:2023)
Ta slovenski standard je istoveten z: prEN ISO 11781
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
oSIST prEN ISO 11781:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11781:2024

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oSIST prEN ISO 11781:2024
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11781
ISO/TC 34/SC 16 Secretariat: ANSI
Voting begins on: Voting terminates on:
2023-11-29 2024-02-21
Molecular biomarker analysis — General guidelines for
single-laboratory validation of qualitative real-time PCR
methods
ICS: 67.050
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 11781:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 3 ----------------------
oSIST prEN ISO 11781:2024
ISO/DIS 11781:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 11781
ISO/TC 34/SC 16 Secretariat: ANSI
Voting begins on: Voting terminates on:

Molecular biomarker analysis — General guidelines for
single-laboratory validation of qualitative real-time PCR
methods
ICS: 67.050
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
ISO copyright office
USER PURPOSES, DRAFT INTERNATIONAL
CP 401 • Ch. de Blandonnet 8
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
CH-1214 Vernier, Geneva
POTENTIAL TO BECOME STANDARDS TO
Phone: +41 22 749 01 11
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: copyright@iso.org
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 11781:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

---------------------- Page: 4 ----------------------
oSIST prEN ISO 11781:2024
ISO/DIS 11781:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references .
...

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