EN ISO 20813:2022

Molecular biomarker analysis - Methods of analysis for the detection and identification of animal species in foods and food products (nucleic acid-based methods) - General requirements and definitions (ISO 20813:2019)

This document specifies minimum requirements of performance characteristics for the detection of nucleic acid sequences (DNA) by molecular methods, such as the polymerase chain reaction (PCR), including different post-PCR detection methods, real-time PCR, single and/or multiple probe-based detection techniques as well as the combination of such methods.
The document is applicable to the detection, identification and quantification of DNA from animal species of higher and lower taxonomic groups in foodstuffs, and the validation of applicable methods.
It is applicable to mammals, birds, reptiles, amphibians, fishes, molluscs, crustaceans and insects. Typical examples for each are listed in Annex A.

Untersuchung auf molekulare Biomarker - Verfahren zur Identifizierung und zum Nachweis von Tierarten in Lebensmitteln (Nukleinsäureverfahren) - Allgemeine Anforderungen und Definitionen (ISO 20813:2019)

Dieses Dokument legt die Mindestanforderungen an die Leistungsmerkmale für den Nachweis von Nuklein-säuresequenzen (DNA) durch molekulare Verfahren, wie z. B. die Polymerase-Kettenreaktion (PCR), einschließlich verschiedener Post-PCR-Nachweisverfahren, Real-time-PCR, auf Einzel- und/oder Mehrfach¬sonden basierender Nachweisverfahren sowie der Kombination derartiger Verfahren, fest.
Das Dokument ist für den Nachweis, die Identifizierung und die quantitative Bestimmung von DNA von Tierarten höherer und niedrigerer taxonomischer Gruppen in Lebensmitteln sowie für die Validierung der entsprechenden Verfahren anwendbar.
Es ist für Säugetiere, Vögel, Reptilien, Amphibien, Fische, Weichtiere, Schalentiere und Insekten geeignet. Jeweils typische Beispiele sind in Anhang A aufgeführt.

Analyse moléculaire de biomarqueurs - Méthodes d'analyse pour la détection et l'identification des espèces animales dans les aliments et les produits alimentaires (méthodes basées sur l'utilisation des acides nucléiques) - Exigences générales et définitions (ISO 20813:2019)

Le présent document spécifie les exigences minimales concernant les caractéristiques de performances pour la détection de séquences d'acide nucléique (ADN) par des méthodes moléculaires telles que la réaction de polymérisation en chaîne (PCR), incluant différentes méthodes de détection post-PCR, la PCR en temps réel, des techniques de détection basées sur une et/ou plusieurs sondes, ainsi que la combinaison de ces méthodes.
Le présent document est applicable à la détection, l'identification, la quantification de l'ADN d'espèces animales appartenant à des groupes taxonomiques supérieurs ou inférieurs dans les produits alimentaires, ainsi que la validation des méthodes applicables.
Il est applicable aux mammifères, aux oiseaux, aux reptiles, aux amphibiens, aux poissons, aux mollusques, aux crustacés et aux insectes. Pour chacun d'entre eux, des exemples typiques sont fournis dans l'Annexe A.

Analiza molekularnih biomarkerjev - Analitske metode za odkrivanje in prepoznavanje živalskih vrst v živilih in živilskih proizvodih (metodana osnovi nukleinskih kislin) - Splošne zahteve in definicije (ISO 20813:2019)

Ta dokument določa minimalne zahteve glede lastnostni delovanja za ugotavljanje zaporedij nukleinske kisline (DNA) z molekularnimi metodami, kot so verižne reakcije s polimerazo, vključno z različnimi postopki za ugotavljanje po verižnih reakcijah s polimerazo, verižne reakcije s polimerazo v realnem času, tehnike z enkratnim in/ali večkratnim ugotavljanjem s sondo in kombinacije teh metod.
Dokument se uporablja za zaznavanje, identifikacijo in kvantifikacijo nukleinske kisline živalskih vrst višjih in nižjih taksonomskih skupin v krmi in za potrjevanje veljavnih metod.
Uporablja se za sesalce, ptice, plazilce, dvoživke, ribe, školjke, rake in insekte. Tipični primeri za vsako skupino so prikazani v dodatku A.

General Information

• Status: Published
• Publication Date: 20-Dec-2022
• ICS: 67.050 - General methods of tests and analysis for food products
• Technical Committee: CEN/TC 460 - Food Authenticity
• Drafting Committee: CEN/TC 460/WG 2 - Species analyses using DNA-based methods
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 21-Dec-2022
• Due Date: 25-Oct-2024
• Completion Date: 21-Dec-2022
• Ref Project: SIST EN ISO 20813:2023 - Molecular biomarker analysis - Methods of analysis for the detection and identification of animal species in foods and food products (nucleic acid-based methods) - General requirements and definitions (ISO 20813:2019)

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2023
Analiza molekularnih biomarkerjev - Analitske metode za odkrivanje in
prepoznavanje živalskih vrst v živilih in živilskih proizvodih (metodana osnovi
nukleinskih kislin) - Splošne zahteve in definicije (ISO 20813:2019)
Molecular biomarker analysis - Methods of analysis for the detection and identification of
animal species in foods and food products (nucleic acid-based methods) - General
requirements and definitions (ISO 20813:2019)
Untersuchung auf molekulare Biomarker - Verfahren zur Identifizierung und zum
Nachweis von Tierarten in Lebensmitteln (Nukleinsäureverfahren) - Allgemeine
Anforderungen und Definitionen (ISO 20813:2019)
Analyse moléculaire de biomarqueurs - Méthodes d'analyse pour la détection et
l'identification des espèces animales dans les aliments et les produits alimentaires
(méthodes basées sur l'utilisation des acides nucléiques) - Exigences générales et
définitions (ISO 20813:2019)
Ta slovenski standard je istoveten z: EN ISO 20813:2022
ICS:
67.050 Splošne preskusne in General methods of tests and
analizne metode za živilske analysis for food products
proizvode
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 20813
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2022
EUROPÄISCHE NORM
ICS 67.050
English Version
Molecular biomarker analysis - Methods of analysis for the
detection and identification of animal species in foods and
food products (nucleic acid-based methods) - General
requirements and definitions (ISO 20813:2019)
Analyse moléculaire de biomarqueurs - Méthodes Untersuchung auf molekulare Biomarker - Verfahren
d'analyse pour la détection et l'identification des zur Identifizierung und zum Nachweis von Tierarten in
espèces animales dans les aliments et les produits Lebensmitteln (Nukleinsäureverfahren) - Allgemeine
alimentaires (méthodes basées sur l'utilisation des Anforderungen und Definitionen (ISO 20813:2019)
acides nucléiques) - Exigences générales et définitions
(ISO 20813:2019)
This European Standard was approved by CEN on 18 December 2022.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 20813:2022 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 20813:2019 has been prepared by Technical Committee ISO/TC 34 "Food products” of
the International Organization for Standardization (ISO) and has been taken over as EN ISO 20813:2022
by Technical Committee CEN/TC 460 “Food Authenticity” the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by June 2023, and conflicting national standards shall be
withdrawn at the latest by June 2023.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 20813:2019 has been approved by CEN as EN ISO 20813:2022 without any modification.

INTERNATIONAL ISO
STANDARD 20813
First edition
2019-05
Molecular biomarker analysis —
Methods of analysis for the detection
and identification of animal species
in foods and food products (nucleic
acid-based methods) — General
requirements and definitions
Analyse moléculaire de biomarqueurs — Méthodes d'analyse pour la
détection et l'identification des espèces animales dans les aliments et
les produits alimentaires (méthodes basées sur l'utilisation des acides
nucléiques) — Exigences générales et définitions
Reference number
ISO 20813:2019(E)
©
ISO 2019
ISO 20813:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Fax: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 20813:2019(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Performance characteristics of the methods . 2
4.1 General . 2
4.2 Scope of the method . 2
4.3 Scientific basis . 2
4.4 Units of measurement . . 2
4.5 Applicability . 2
4.6 Specificity . 3
4.6.1 General. 3
4.6.2 Requirements for inclusivity testing . 3
4.6.3 Requirements for exclusivity testing . 3
4.7 Sensitivity . 4
4.7.1 General. 4
4.7.2 Limit of detection (LOD) . 4
4.8 Specific requirements for quantitative methods . 5
4.8.1 General. 5
4.8.2 Limit of quantification (LOQ) . 5
4.8.3 Dynamic range . 5
4.8.4 Determination of precision and trueness for quantitative methods . 6
4.9 Robustness . 6
4.9.1 General. 6
4.9.2 Robustness determination by interlaboratory study . 6
4.9.3 Robustness determination by a multifactorial orthogonal test design . 6
5 Single-laboratory validation . 6
6 Interlaboratory study (collaborative study) . 7
6.1 General . 7
6.2 Qualitative methods. 7
6.3 Quantitative methods . 7
7 General laboratory and procedural requirements . 7
7.1 General . 7
7.2 Facilities, materials and equipment . 8
7.3 Sample preparation and DNA extraction . 8
7.4 Use of controls . 9
7.5 Data analysis . 9
7.5.1 Control . 9
7.5.2 Conventional PCR .10
7.5.3 Real-time PCR amplification curves .10
7.6 Expression of results .
...