EN ISO 16140-7:2024

Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO 16140-7:2024)

This document specifies the general principle and the technical protocol for the validation of identification methods of microorganisms for microbiology in the food chain. As there is no reference method, no method comparison study can be run. Therefore, this document provides a protocol to evaluate the performance characteristics and validate the method workflow using well-defined strains. When required, an additional identification method can be used.
This document is applicable to the validation of identification methods of microorganisms that are used for the analysis of isolated colonies from:
—     products intended for human consumption;
—     products for feeding animals;
—     environmental samples in the area of food and feed production and handling;
—     samples from the primary production stage.
Identification methods only validated in accordance with this document cannot be used instead of confirmation described in:
—     the reference method;
—     an alternative method validated in accordance with ISO 16140-2;
—     an alternative method validated in accordance with ISO 16140-6.
In these instances, the identification method is validated in accordance with ISO 16140-6 method that is used as a confirmation method.
This document is applicable to bacteria and fungi. Some clauses can be applicable to other (micro)organisms, which can be determined on a case-by-case basis.

Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 7: Arbeitsvorschrift für die Validierung von Identifizierungsverfahren von Mikroorganismen (ISO 16140 7:2024)

Dieses Dokument legt die allgemeinen Grundsätze und die technische Arbeitsvorschrift für die Validierung von Verfahren zur Identifizierung von Mikroorganismen in der mikrobiologischen Lebensmitteluntersuchung fest. Da es kein Referenzverfahren gibt, kann keine Verfahrensvergleichsuntersuchung durchgeführt werden. Daher gibt dieses Dokument eine Arbeitsvorschrift für die Bewertung der Leistungsmerkmale und die Validierung des Verfahrensablaufs unter Verwendung wohldefinierter Stämme vor. Falls nötig kann ein ergänzendes Identifizierungsverfahren angewendet werden.
Dieses Dokument ist anwendbar auf die Validierung von Verfahren zur Identifizierung von Mikroorganismen, wobei es sich um Verfahren handelt, die angewendet werden bei der Analyse von isolierten Kolonien in:
   Erzeugnissen, die für den menschlichen Verzehr vorgesehen sind;
   Erzeugnissen, die Futtermittel sind;
   Umgebungsproben im Bereich der Herstellung und Handhabung von Lebensmitteln und Futtermitteln;
   Proben aus dem Bereich der Primärproduktion.
Validierte Identifizierungsverfahren können nicht anstelle einer Bestätigung verwendet werden, die beschrieben ist in:
   dem Referenzverfahren;
   einem in Übereinstimmung mit ISO 16140 2 validierten alternativen Verfahren;
   einem in Übereinstimmung mit ISO 16140 6 validierten alternativen Verfahren.
In diesen Fällen wird das Identifizierungsverfahren in Übereinstimmung mit ISO 16140 6 validiert, das als Bestätigungsverfahren verwendet wird.
Dieses Dokument ist anwendbar für Bakterien und Pilze. Einige Abschnitte können im Einzelfall auf andere (Mikro-)Organismen anwendbar sein.

Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 7: Protocole pour la validation de méthodes d’identification des micro-organismes (ISO 16140-7:2024)

Le présent document spécifie le principe général ainsi que le protocole technique pour la validation de méthodes d’identification des micro-organismes dans le domaine de la microbiologie de la chaîne alimentaire. Dans la mesure où il n’existe pas de méthode de référence, une étude de comparaison des méthodes ne peut être entreprise. Par conséquent, le présent document fournit un protocole pour évaluer les caractéristiques de performance et valider le flux de travail de la méthode utilisant des souches bien définies. Si nécessaire, une méthode d’identification supplémentaire peut être utilisée.
Le présent document est applicable à la validation de méthodes d’identification des micro-organismes qui sont utilisées pour l’analyse de colonies isolées provenant:
—     les produits destinés à la consommation humaine;
—     les produits destinés à l’alimentation animale;
—     les échantillons environnementaux dans le domaine de la production et de la manutention de produits alimentaires;
—     les échantillons au stade de la production primaire.
Les méthodes d'identification validées uniquement conformément au présent document ne peuvent pas être utilisées pour remplacer le mode opératoire de confirmation décrit dans:
—     la méthode de référence;
—     une méthode alternative validée conformément à l’ISO 16140-2;
—     une méthode alternative validée conformément à l’ISO 16140-6.
Dans ces cas, la méthode d’identification est validée conformément à la méthode de l’ISO 16140-6 qui est utilisée comme méthode de confirmation.
Le présent document est applicable aux bactéries et aux champignons. Certains articles peuvent être applicables à d’autres (micro-)organismes, qui peuvent être déterminés au cas par cas.

Mikrobiologija v prehranski verigi - Validacija metode - 7. del: Protokol za validacijo metod za identifikacijo mikroorganizmov (ISO 16140-7:2024)

General Information

• Status: Published
• Publication Date: 12-Nov-2024
• ICS: 07.100.30 - Food microbiology
• Technical Committee: CEN/TC 463 - Microbiology of the food chain
• Drafting Committee: CEN/TC 463 - Microbiology of the food chain
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 13-Nov-2024
• Completion Date: 13-Nov-2024
• Ref Project: SIST EN ISO 16140-7:2025 - Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of identification methods of microorganisms (ISO 16140-7:2024)

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2025
Mikrobiologija v prehranski verigi - Validacija metode - 7. del: Protokol za
validacijo metod za identifikacijo mikroorganizmov (ISO 16140-7:2024)
Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of
identification methods of microorganisms (ISO 16140-7:2024)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 7: Arbeitsvorschrift für
die Validierung von Identifizierungsverfahren von Mikroorganismen (ISO 16140-7:2024)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 7: Protocole
pour la validation de méthodes d’identification des micro-organismes (ISO 16140-
7:2024)
Ta slovenski standard je istoveten z: EN ISO 16140-7:2024
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 16140-7
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2024
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Method validation - Part 7:
Protocol for the validation of identification methods of
microorganisms (ISO 16140-7:2024)
Microbiologie de la chaîne alimentaire - Validation des Mikrobiologie der Lebensmittelkette -
méthodes - Partie 7: Protocole pour la validation de Verfahrensvalidierung - Teil 7: Arbeitsvorschrift für die
méthodes d'identification des micro-organismes (ISO Validierung von Identifizierungsverfahren von
16140-7:2024) Mikroorganismen (ISO 16140 7:2024)
This European Standard was approved by CEN on 6 October 2024.

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
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16140-7:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 16140-7:2024) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 463 “Microbiology of the food chain” the
secretariat of which is held by AFNOR.
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 May 2025, and conflicting national standards shall be
withdrawn at the latest by May 2025.
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/national committee. 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 16140-7:2024 has been approved by CEN as EN ISO 16140-7:2024 without any
modification.
International
Standard
ISO 16140-7
First edition
Microbiology of the food chain —
2024-11
Method validation —
Part 7:
Protocol for the validation
of identification methods of
microorganisms
Microbiologie de la chaîne alimentaire — Validation des
méthodes —
Partie 7: Protocole pour la validation de méthodes
d’identification des micro-organismes
Reference number
ISO 16140-7:2024(en) © ISO 2024

ISO 16140-7:2024(en)
© ISO 2024
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]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 16140-7:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General principles for the validation of identification methods of microorganisms . 4
5 Strains . 4
6 Performance characteristics of an identification method . 5
6.1 General .5
6.2 Description of the concept and limitation(s) of the identification method .5
6.3 Identification reliability of the identification method .6
6.3.1 Number of strains to be tested .6
6.3.2 Selection of the strains .7
6.3.3 Testing of the strains .7
6.3.4 Expression and interpretation of results .8
6.4 Evaluation .9
7 Interlaboratory study .10
7.1 General .10
7.2 Data sets to be obtained .10
7.3 Protocol .11
7.4 Expression of results . .11
7.5 Interpretation and evaluation . 12
Annex A (informative) Guidelines for the validation of methods for the identification
of microorganisms in ecosystems . 14
Annex B (normative) Points to be considered when selecting strains for an identification
reliability study .21
Annex C (informative) Expression, interpretation and evaluation of results.22
Annex D (informative) Illustrations on the validation of methods for the identification
of microorganisms in ecosystems .30
Bibliography .35

iii
ISO 16140-7:2024(en)
Foreword
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bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
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This document was prepared by Technical Committee ISO/TC 34, Food products, Subcommittee SC 9,
Microbiology, in collaboration with the European Committee for Standardization (CEN) Technical Committee
CEN/TC 463, Microbiology of the food chain, in accordance with the Agreement on technical cooperation
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