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

Standards Content (Sample)

SLOVENSKI STANDARD
oSIST prEN ISO 16140-7:2023
01-julij-2023
Mikrobiologija v prehranski verigi - Validacija metode - 7. del: Protokol za
validacijo metod za identifikacijo mikroorganizmov (ISO/DIS 16140-7:2023)
Microbiology of the food chain - Method validation - Part 7: Protocol for the validation of
identification methods of microorganisms (ISO/DIS 16140-7:2023)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 7: Arbeitsvorschrift für
die Validierung von Identifizierungsverfahren von Mikroorganismen (ISO/DIS 16140
7:2023)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 7: Protocole
pour la validation de méthodes d’identification des micro-organismes (ISO/DIS 16140-
7:2023)
Ta slovenski standard je istoveten z: prEN ISO 16140-7
ICS:
07.100.30 Mikrobiologija živil Food microbiology
oSIST prEN ISO 16140-7:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 16140-7:2023
oSIST prEN ISO 16140-7:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16140-7
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2023-04-27 2023-07-20
Microbiology of the food chain — Method validation —
Part 7:
Protocol for the validation of identification methods of
microorganisms
ICS: 07.100.30
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.
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NATIONAL REGULATIONS.
ISO/DIS 16140-7:2023(E)
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 16140-7:2023
ISO/DIS 16140-7:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16140-7
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:

Microbiology of the food chain — Method validation —
Part 7:
Protocol for the validation of identification methods of
microorganisms
ICS: 07.100.30
This document is circulated as received from the committee secretariat.
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
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WHICH REFERENCE MAY BE MADE IN
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Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 16140-7:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

oSIST prEN ISO 16140-7:2023
ISO/DIS 16140-7:2023(E)
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 . 5
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 accuracy of the identification method . 6
6.3.1 Number of strains to be tested . 6
6.3.2 Selection of the strains . 8
6.3.3 Testing of the strains . 8
6.3.4 Expression and interpretation of results . 8
6.4 Evaluation . 9
7 Interlaboratory study .11
7.1 General . 11
7.2 Data sets to be obtained . 11
7.3 Protocol . 11
7.4 Expression of results . .12
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
accuracy 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 .28
Bibliography .33
iii
oSIST prEN ISO 16140-7:2023
ISO/DIS 16140-7:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
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 between ISO and CEN (Vienna Agreement).
A list of all parts of the ISO 16140 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body.
A complete listing of these bodies can be found at www.iso.org/members.html.
iv
oSIST prEN ISO 16140-7:2023
ISO/DIS 16140-7:2023(E)
Introduction
0.1  The ISO 16140 series
The ISO 16140 series has been expanded in response to the need for various ways to validate or verify
test methods. It is the successor to ISO 16140:2003. The ISO 16140 series consists of several parts with
the general title, Microbiology of the food chain — Method validation:
— Part 1: Vocabulary;
— Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method;
— Part 3: Protocol for the verification of reference methods and validated alternative methods in a single
laboratory;
— Part 4: Protocol for method validation in a single laboratory;
— Part 5: Protocol for factorial interlaboratory validation for non-proprietary methods;
— Part 6: Protocol for the validation of alternative (proprietary) methods for microbiological confirmation
and typing procedures;
— Part 7: Protocol for the validation of identification methods of microorganisms.
ISO 17468 is a closely linked International Standard, which establishes technical rules for the
development and validation of standardized methods.
In general, two stages are needed before a method can be used in a laboratory.
— The first stage is the validation of the method. Validation is conducted using a study in a single
laboratory followed by an interlaboratory study (see ISO 16140-2, ISO 16140-5, ISO 16140-6 and
as described in this document). In the case when a method is validated within one laboratory (see
ISO 16140-4), no interlaboratory study is conducted.
— The second stage is method verification, where a laboratory demonstrates that it can satisfactorily
perform a validated method. This is described in ISO 16140-3. Verification is only applicable to
methods that have been validated using an interlaboratory study.
In general, two types of methods are distinguished: reference methods and alternative methods.
A reference method is defined in ISO 16140-1:2016, 2.59, as an “internationally recognized and widely
accepted method”. The note to entry clarifies that “these are ISO standards and standards jointly
published by ISO and CEN or other regional/national standards of equivalent standing”.
In the ISO 16140 series, reference methods include standardized reference (ISO and CEN) methods as
defined in ISO/DIS 17468, 3.5, as a “reference method described in a standard”.
An alternative method (method submitted for validation) is defined in ISO 16140-1:2016, 2.4, as a
“method of analysis that detects or quantifies, for a given category of products, the same analyte as
is
...