EN ISO 16140-2:2016/FprA1
(Amendment)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 (ISO 16140-2:2016/FDAM 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: 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 (ISO 16140-2:2016/FDAM 1:2024)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für die Validierung von alternativen (urheberrechtlich geschützten) Verfahren anhand eines Referenzverfahrens - ÄNDERUNG 1(ISO 16140 2:2016/FDAM1:2024)
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: Titre manque (ISO 16140-2:2016/FDAM 1:2024)
Mikrobiologija v prehranski verigi - Validacija metode - 2. del: Protokol za validacijo alternativnih (lastniških) metod glede na referenčno metodo - Dopolnilo 1: Revizija vrednotenja podatkov študije kvalitativne primerjave metod, izračunov relativne stopnje zaznavnosti v medlaboratorijski študiji, izračuna in razlage študije relativne pravilnosti ter vključitev komercialnega protokola za preskušanje sterilnosti za določene izdelke (ISO 16140-2:2016/FDAM 1:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16140-2:2016/oprA1:2023
01-oktober-2023
Mikrobiologija v prehranski verigi - Validacija metode - 2. del: Protokol za
validacijo alternativnih (lastniških) metod glede na referenčno metodo - Dopolnilo
A1
Microbiology of the food chain - Method validation - Part 2: Protocol for the validation of
alternative (proprietary) methods against a reference method
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 2: Arbeitsvorschrift für
die Validierung von alternativen (urheberrechtlich geschützten) Verfahren anhand eines
Referenzverfahrens
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
Ta slovenski standard je istoveten z: EN ISO 16140-2:2016/prA1
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 16140-2:2016/oprA1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
SIST EN ISO 16140-2:2016/oprA1:2023
SIST EN ISO 16140-2:2016/oprA1:2023
DRAFT AMENDMENT
ISO 16140-2:2016/DAM 1
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2023-07-18 2023-10-10
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 MCS data evaluation,
RLOD calculations in the ILS, calculation and interpretation
of the RT study, and inclusion of a commercial sterility testing
protocol for specific products
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 16140-2:2016/DAM 1:2023(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
SIST EN ISO 16140-2:2016/oprA1:2023
ISO 16140-2:2016/DAM 1:2023(E)
DRAFT AMENDMENT
ISO 16140-2:2016/DAM 1
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
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 MCS data evaluation,
RLOD calculations in the ILS, calculation and interpretation
of the RT study, and inclusion of a commercial sterility testing
protocol for specific products
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
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NATIONAL REGULATIONS.
Website: www.iso.org ISO 16140-2:2016/DAM 1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
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ii
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023
SIST EN ISO 16140-2:2016/oprA1:2023
ISO 16140-2:2016/DAM 1:2023(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 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
SIST EN ISO 16140-2:2016/oprA1:2023
SIST EN ISO 16140-2:2016/oprA1:2023
ISO 16140-2:2016/DAM 1:2023(E)
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 MCS data evaluation,
RLOD calculations in the ILS, calculation and interpretation
of the RT 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 ISO 16140-2, 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.
SIST EN ISO 16140-2:2016/oprA1:2023
ISO 16140-2:2016/DAM 1:2023(E)
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 17468:2016, 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 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 ISO 16140-2 cannot be reached. ISO 16140-4 and ISO 16140-5 can be used for
validation against a reference method. ISO 16140-4 (regarding qualitative and quantitative methods)
and ISO 16140-5 (regarding quantitative methods only) can also be used for validation without a
reference method.
The flow chart in Figure 0.1 gives an overview of the links between the different parts mentioned
above. It also guides the user in selecting the right part of the ISO 16140 series, taking into account the
purpose of the study and the remarks given above.
Figure 0.1 — Flow chart for application of the ISO 16140 series
SIST EN ISO 16140-2:2016/oprA1:2023
ISO 16140-2:2016/DAM 1:2023(E)
NOTE In this document, the words “category”, “type” and/or “item” are sometimes combined with “(food)”
to improve readability. However, the word “(food)” is interchangeable with “(feed)” and other areas of the food
chain as mentioned in Clause 1.
ISO 16140-6 is somewhat different from the other parts in the ISO 16140 series in that it relates to
a very specific situation where only the confirmation procedure of a method is to be validated [e.g.
the biochemical confirmation of Enterobacteriaceae (see ISO 21528-2)]. The confirmation procedure
advances a suspected (presumptive) result to a confirmed positive result. The validation of alternative
typing techniques (e.g. serotyping of Salmonella) is also covered by ISO 16140-6. The validation study
in ISO 16140-6 clearly defines the selective agar(s) from which strains can be confirmed using the
alternative confirmation method. If successfully validated, the alternative confirmation method can
only be used if strains are recovered on an agar that was used and shown to be acceptable within the
validation study. Figure 0.2 shows the possibilities where an alternative confirmation method validated
in accordance with ISO 16140-6 can be applied (see text in the boxes).
Figure 0.2 — Use of validated alternative confirmation methods (see ISO 16140-6)
EXAMPLE An example application of a validated alternative confirmation method is as follows.
An alternative confirmation method based on ELISA has been validated (in accordance with
ISO 16140-6) to replace the biochemical confirmation for Salmonella as described in ISO 6579-1. In
the validation study, XLD (mandatory agar in accordance with ISO 6579-1) plus BGA and a specified
chromogenic agar (two optional agars for second plating in accordance with ISO 6579-1) were used
as the agars to start the confirmation. The validated confirmation method can be used to replace the
biochemical confirmation under the following conditions:
— by laboratories using the ISO 6579-1; or
— by laboratories using an ISO 16140-2 validated alternative method that refers to ISO 6579-1 for
confirmation; or
— by laboratories using an ISO 16140-2 validated alternative method that starts the confirmation
from XLD and/or BGA agar and/or the specified chromogenic agar.
The validated confirmation method cannot be used under the following conditions:
— by laboratories using an ISO 16140-2 validated alternative method that refers only to agars other
than those included in the validation to start the confirmation (e.g. Hektoen agar and SS agar only);
or
SIST EN ISO 16140-2:2016/oprA1:2023
ISO 16140-2:2016/DAM 1:2023(E)
— by laboratories using an ISO 16140-2 validated alternative method that refers only to a confirmation
procedure that does not requir
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