EN ISO 16140-2:2016/A1:2024
(Amendment)Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method - Amendment 1:
Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method - Amendment 1:
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für die Validierung von alternativen (urheberrechtlich geschützten) Verfahren anhand eines Referenzverfahrens - ÄNDERUNG 1(ISO 16140 2:2016/Amd 1:2024)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 2: Protocole pour la validation de méthodes alternatives (commerciales) par rapport à une méthode de référence - Amendement 1:
Mikrobiologija v prehranski verigi - Validacija metode - 2. del: Protokol za validacijo alternativnih (lastniških) metod glede na referenčno metodo - Dopolnilo A1 (ISO 16140-2:2016/Amd 1:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2024
Mikrobiologija v prehranski verigi - Validacija metode - 2. del: Protokol za
validacijo alternativnih (lastniških) metod glede na referenčno metodo - Dopolnilo
A1 (ISO 16140-2:2016/Amd 1:2024)
Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of
alternative (proprietary) methods against a reference method - Amendment 1 (ISO
16140-2:2016/Amd 1:2024)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für
die Validierung von alternativen (urheberrechtlich geschützten) Verfahren anhand eines
Referenzverfahrens (ISO 16140-2:2016/Amd 1:2024)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 2: Protocole
pour la validation de méthodes alternatives (commerciales) par rapport à une méthode
de référence - Amendement 1 (ISO 16140-2:2016/Amd 1:2024)
Ta slovenski standard je istoveten z: EN ISO 16140-2:2016/A1:2024
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 16140-2:2016/A1
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2024
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Method validation - Part 2:
Protocol for the validation of alternative (proprietary)
methods against a reference method - Amendment 1 (ISO
16140-2:2016/Amd 1:2024)
Microbiologie de la chaîne alimentaire - Validation des Mikrobiologie der Lebensmittelkette -
méthodes - Partie 2: Protocole pour la validation de Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für die
méthodes alternatives (commerciales) par rapport à Validierung von alternativen (urheberrechtlich
une méthode de référence - Amendement 1(ISO 16140 geschützten) Verfahren anhand eines
2:2016/Amd 1:2024) Referenzverfahrens - ÄNDERUNG 1(ISO 16140
2:2016/Amd 1:2024)
This amendment A1 modifies the European Standard EN ISO 16140-2:2016; it was approved by CEN on 25 July 2024.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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 NORMALISATIO N
EUROPÄISCHES KOMITEE FÜR N O RMU N G
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 16140-2:2016/A1:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 16140-2:2016/A1:2024) 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 Amendment to the European Standard EN ISO 16140-2:2016 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by March 2025, and
conflicting national standards shall be withdrawn at the latest by March 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 16140-2:2016/Amd 1:2024 has been approved by CEN as EN ISO 16140-
2:2016/A1:2024 without any modification.
International
Standard
ISO 16140-2
First edition
Microbiology of the food chain —
2016-06-15
Method validation —
AMENDMENT 1
Part 2:
2024-09
Protocol for the validation of
alternative (proprietary) methods
against a reference method
AMENDMENT 1: Revision of
qualitative method comparison
study data evaluation, relative level
of detection calculations in the
interlaboratory study, calculation and
interpretation of the relative trueness
study, and inclusion of a commercial
sterility testing protocol for specific
products
Microbiologie de la chaîne alimentaire — Validation des
méthodes —
Partie 2: Protocole pour la validation de méthodes alternatives
(commerciales) par rapport à une méthode de référence
AMENDEMENT 1: Révision de l’évaluation des données des études
de comparaison de méthodes qualitatives, des calculs du niveau
de détection de l'étude interlaboratoires et de l’interprétation
de l’étude de justesse relative, et ajout d’un protocole pour la
détermination de la stérilité commerciale pour des produits
spécifiques
Reference number
ISO 16140-2:2016/Amd.1:2024(en) © ISO 2024
ISO 16140-2:2016/Amd.1:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 16140-2:2016/Amd.1:2024(en)
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 in 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.
iii
ISO 16140-2:2016/Amd.1:2024(en)
Microbiology of the food chain — Method validation —
Part 2:
Protocol for the validation of alternative (proprietary)
methods against a reference method
AMENDMENT 1: Revision of qualitative method comparison study
data evaluation, relative level of detection calculations in the
interlaboratory study, calculation and interpretation of the relative
trueness study, and inclusion of a commercial sterility testing
protocol for specific products
Introduction
Replace the text with the following:
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 six 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.
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 this document, ISO 16140-5 and ISO 16140-6). 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.
ISO 16140-2:2016/Amd.1:2024(en)
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 17468:2023, 3.7, 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 detected or
quantified using the corresponding reference method”. The note to entry clarifies that: “The method can be
proprietary. The term ‘alternative’ is used to refer to the entire ‘test procedure and reaction system’. This
term includes all ingredients, whether material or otherwise, required for implementing the method.”
ISO 16140-4 addresses validation within a single laboratory. The results are therefore only valid for the
laboratory that conducted the study. In this case, verification (as described in ISO 16140-3) is not applicable.
ISO 16140-5 describes protocols for non-proprietary methods where a more rapid validation is required or
when the method to be validated is highly specialized and the number of participating laboratories required
by this document cannot be reached. ISO 16140-4 and ISO 16140-5 can be used for validation against a
reference method. ISO 16140-4 (regarding qualit
...
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