prEN ISO 6579-4

Microbiology of the food chain - Horizontal method for the detection, enumeration and serotyping of Salmonella - Part 4: Identification of monophasic Salmonella Typhimurium (1,4,[5],12:i:-) by polymerase chain reaction (PCR) (ISO/DIS 6579-4:2023)

Mikrobiologie der Lebensmittelkette - Horizontales Verfahren zum Nachweis von Salmonella spp. - Teil 4: Identifizierung von monophasischen Salmonella Typhimurium (1,4,[5],12:i:-) durch Polymerase‑Kettenreaktion (PCR) (ISO/DIS 6579‑4:2023)

Microbiologie de la chaîne alimentaire - Méthode horizontale pour la recherche, le dénombrement et le sérotypage des Salmonella - Partie 4: Identification du variant monophasique de Salmonella Typhimurium (1,4,[5],12:i:-) par réaction de polymérisation en chaîne (PCR) (ISO/DIS 6579-4:2023)

Mikrobiologija v prehranski verigi - Horizontalna metoda za ugotavljanje prisotnosti, števila in serotipov Salmonella - 4. del: Identifikacija monofazne Salmonelle Typhimurium (1,4,[5],12:i:-) z verižno reakcijo s polimerazo (PCR) (ISO/DIS 6579-4:2023)

General Information

• Status: Not Published
• Publication Date: 20-Jul-2025
• 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: 4599 - Dispatch of FV draft to CMC - Finalization for Vote
• Start Date: 25-Sep-2024
• Completion Date: 25-Sep-2024
• Ref Project: oSIST prEN ISO 6579-4:2024 - Microbiology of the food chain - Horizontal method for the detection, enumeration and serotyping of Salmonella - Part 4: Identification of monophasic Salmonella Typhimurium (1,4,[5],12:i:-) by polymerase chain reaction (PCR) (ISO/DIS 6579-4:2023)

Standards Content (Sample)

SLOVENSKI STANDARD
01-marec-2024
Mikrobiologija v prehranski verigi - Horizontalna metoda za ugotavljanje
prisotnosti, števila in serotipov Salmonella - 4. del: Identifikacija monofazne
Salmonelle Typhimurium (1,4,[5],12:i:-) z verižno reakcijo s polimerazo (PCR)
(ISO/DIS 6579-4:2023)
Microbiology of the food chain - Horizontal method for the detection, enumeration and
serotyping of Salmonella - Part 4: Identification of monophasic Salmonella Typhimurium
(1,4,[5],12:i:-) by polymerase chain reaction (PCR) (ISO/DIS 6579-4:2023)
Mikrobiologie der Lebensmittelkette - Horizontales Verfahren zum Nachweis von
Salmonella spp. - Teil 4: Identifizierung von monophasischen Salmonella Typhimurium
(1,4,[5],12:i:-) durch Polymerase‑Kettenreaktion (PCR) (ISO/DIS 6579-4:2023)
Microbiologie de la chaîne alimentaire - Méthode horizontale pour la recherche, le
dénombrement et le sérotypage des Salmonella - Partie 4: Identification du variant
monophasique de Salmonella Typhimurium (1,4,[5],12:i:-) par réaction de polymérisation
en chaîne (PCR) (ISO/DIS 6579-4:2023)
Ta slovenski standard je istoveten z: prEN ISO 6579-4
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT INTERNATIONAL STANDARD
ISO/DIS 6579-4
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:
2023-12-22 2024-03-15
Microbiology of the food chain — Horizontal method
for the detection, enumeration and serotyping of
Salmonella —
Part 4:
Identification of monophasic Salmonella Typhimurium
(1,4,[5],12:i:-) by polymerase chain reaction (PCR)
Microbiologie de la chaîne alimentaire — Méthode horizontale pour la recherche, le dénombrement et le
sérotypage des Salmonella —
Partie 4: Identification de Salmonella Typhimurium (1,4,[5],12:i:-) monophasique par réaction de
polymérisation en chaîne (PCR)
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/DIS 6579-4:2023(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

ISO/DIS 6579-4:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 6579-4
ISO/TC 34/SC 9 Secretariat: AFNOR
Voting begins on: Voting terminates on:

Microbiology of the food chain — Horizontal method
for the detection, enumeration and serotyping of
Salmonella —
Part 4:
Identification of monophasic Salmonella Typhimurium
(1,4,[5],12:i:-) by polymerase chain reaction (PCR)
Microbiologie de la chaîne alimentaire — Méthode horizontale pour la recherche, le dénombrement et le
sérotypage des Salmonella —
Partie 4: Identification de Salmonella Typhimurium (1,4,[5],12:i:-) monophasique par réaction de
polymérisation en chaîne (PCR)
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
Phone: [phone]
WHICH REFERENCE MAY BE MADE IN
Reference number
Email: [e-mail]
NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 6579-4:2023(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
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

ISO/DIS 6579-4:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Principle . 3
4.1 General . 3
4.2 Preparation of well-isolated colonies . 3
4.3 Suspension of a colony . 3
4.4 Amplification and detection . 3
5 Culture media and reagents .3
6 Equipment and consumables .3
7 Presumptive monophasic Salmonella Typhimurium strain (isolate) .4
8 Culturing the isolate .4
9 Procedure .4
9.1 Preparation of cell suspension or DNA . 4
9.2 PCR amplification and detection . 5
9.2.1 General . 5
9.2.2 PCR controls . 5
10 Expression of results . 5
11 Performance characteristics of the method . 6
11.1 Validation in accordance with ISO 17468 . 6
11.2 Performance characteristics . 6
11.2.1 Method(s) evaluation study . 6
11.2.2 Interlaboratory study . 6
12 Test report . 7
13 Quality assurance . 7
Annex A (informative) Culture media and reagents . 8
Annex B (informative) Probe-based multiplex real-time PCR assay for the identification of
monophasic Salmonella Typhimurium (1,4[5],12:i:-) .10
Annex C (informative) Agarose gel-based multiplex target PCR assay for the identification
of monophasic Salmonella Typhimurium (1,4[5],12:i:-) .14
Annex D (informative) Agarose gel-based single target PCR assay for the identification of
monophasic Salmonella Typhimurium (1,4[5],12:i:-) .19
Annex E (informative) Performance characteristics .26
Bibliography .32
iii
ISO/DIS 6579-4:2023(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.
A list of all parts in the ISO 6579 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
ISO/DIS 6579-4:2023(E)
Introduction
In several (international, regional, national) laws, regulatory limits are set to ensure the ‘absence’
of Salmonella spp. in samples of the food chain. Moreover, several (EC) Regulations also demand the
absence of particular Salmonella serovars which have shown to cause a relatively high percentage of
human salmonellosis. One of these Salmonella serovars for which legal criteria are set is Salmonella
Typhimurium, including its monophasic variant 1,4[5],
...