SIST EN ISO 16140-4:2020/oprA1:2023

Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory - Amendment 1: Validation of a larger test portion size for qualitative methods (ISO 16140 4:2020/DAM 1:2023)

Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 4: Arbeitsvorschrift für Einzel-Labor-Verfahrensvalidierung - ÄNDERUNG 1: Validierung größerer Prüfmengen für qualitative Verfahren (ISO 16140 4:2020/DAM 1:2023)

Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 4: Protocole pour la validation de méthodes dans un seul laboratoire - Amendement 1: Validation d’une taille de prise d’essai plus grande pour des méthodes qualitatives (ISO 16140 4:2020/DAM 1:2023)

Mikrobiologija v prehranski verigi - Validacija metode - 4. del: Protokol za validacijo metode v posameznem laboratoriju (hišne metode)- Dopolnilo A1: Validacija testnega vzorca večje velikosti za kvalitativne metode (ISO 16140 4:2020/DAM 1:2023)

General Information

• Status: Not Published
• Public Enquiry End Date: 09-Oct-2023
• ICS: 07.100.30 - Food microbiology
• Technical Committee: KŽP - Agricultural food products
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 01-Aug-2023
• Due Date: 19-Dec-2023
• Ref Project: EN ISO 16140-4:2020/prA1 - Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory - Amendment 1: Validation of a larger test portion size for qualitative methods (ISO 16140 4:2020/DAM 1:2023)

Relations

• Amends: SIST EN ISO 16140-4:2020 - Microbiology of the food chain - Method validation - Part 4: Protocol for method validation in a single laboratory (ISO 16140-4:2020)
• Effective Date: 23-Jun-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16140-4:2020/oprA1:2023
01-oktober-2023
Mikrobiologija v prehranski verigi - Validacija metode - 4. del: Protokol za
validacijo metode v posameznem laboratoriju (hišne metode)- Dopolnilo A1:
Validacija testnega vzorca večje velikosti za kvalitativne metode (ISO 16140
4:2020/DAM 1:2023)
Microbiology of the food chain - Method validation - Part 4: Protocol for method validation
in a single laboratory - Amendment 1: Validation of a larger test portion size for
qualitative methods (ISO 16140 4:2020/DAM 1:2023)
Mikrobiologie der Lebensmittelkette - Verfahrensvalidierung - Teil 4: Arbeitsvorschrift für
Einzel-Labor-Verfahrensvalidierung - ÄNDERUNG 1: Validierung größerer Prüfmengen
für qualitative Verfahren (ISO 16140 4:2020/DAM 1:2023)
Microbiologie de la chaîne alimentaire - Validation des méthodes - Partie 4: Protocole
pour la validation de méthodes dans un seul laboratoire - Amendement 1: Validation
d’une taille de prise d’essai plus grande pour des méthodes qualitatives (ISO 16140
4:2020/DAM 1:2023)
Ta slovenski standard je istoveten z: EN ISO 16140-4:2020/prA1
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 16140-4:2020/oprA1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16140-4:2020/oprA1:2023

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SIST EN ISO 16140-4:2020/oprA1:2023
DRAFT AMENDMENT
ISO 16140-4:2020/DAM 1
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2023-07-19 2023-10-11
Microbiology of the food chain — Method validation —
Part 4:
Protocol for method validation in a single laboratory
AMENDMENT 1: Validation of a larger test portion size for
qualitative methods
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.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO 16140-4:2020/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

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SIST EN ISO 16140-4:2020/oprA1:2023
ISO 16140-4:2020/DAM 1:2023(E)
DRAFT AMENDMENT
ISO 16140-4:2020/DAM 1
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:

Microbiology of the food chain — Method validation —
Part 4:
Protocol for method validation in a single laboratory
AMENDMENT 1: Validation of a larger test portion size for
qualitative methods
ICS: 07.100.30
This document is circulated as received from the committee secretariat.
COPYRIGHT PROTECTED DOCUMENT
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
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO 16140-4:2020/DAM 1:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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SIST EN ISO 16140-4:2020/oprA1:2023
ISO 16140-4:2020/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).
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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 2023 – All rights reserved

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SIST EN ISO 16140-4:2020/oprA1:2023

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SIST EN ISO 16140-4:2020/oprA1:2023
ISO 16140-4:2020/DAM 1:2023(E)
Microbiology of the food chain — Method validation —
Part 4:
Protocol for method validation in a single laboratory
AMENDMENT 1: Validation of a larger test portion size for
qualitative methods

Clause 3
Add the following definition:
3.13
larger test portion size
measured (volume or mass) representative sample taken from the laboratory sample or test sample
for use in the preparation of the initial suspension that is larger than the test portion that has been
described in the original method and/or validation document

4.1
Add the following text after the second paragraph:
The protocol which shall be used to validate a larger test portion size for qualitative methods in a single
laboratory is described in Annex H.

Annex H
Add the following annex after Annex G, before the Bibliography.
1
© ISO 2023 – All rights reserved

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SIST EN ISO 16140-4:2020/oprA1:2023
ISO 16140-4:2020/DAM 1:2023(E)
Annex H
(normative)

Validation of a larger test portion size for qualitative methods
H.1 General
This annex describes a protocol for the validation for qualitative methods when using a larger test
portion size. This protocol is intended to demonstrate the effect of analysing a test portion larger than
the test portion initially used to validate the method. Validation of the larger test portion size applies
only to the laboratory conducting the study and only to the specific (food) category used.
Reference methods which were validated using a larger test portion size in accordance with ISO 17468
and alternative (proprietary) methods which were validated using a larger test portion size in
accordance with ISO 16140-2 only need to be verified by a laboratory following ISO 16140-3.
The validated larger test portion size can be used in other laboratories once this has been validated
in an interlaboratory study in accordance with ISO 16140-2 or ISO 16140-5. See the flow diagram in
Figure 1. Once validated in an interlaboratory study, any laboratory can implement the larger test
portion size after verification following ISO 16140-3. If not validated in an interlaboratory study,
validation in acco
...