EN ISO 17468:2023
(Main)Microbiology of the food chain - Technical requirements and guidance on the establishment or revision of a standardized reference method (ISO 17468:2023)
Microbiology of the food chain - Technical requirements and guidance on the establishment or revision of a standardized reference method (ISO 17468:2023)
This document gives technical requirements and guidance on the establishment or revision of standardized reference methods used for the analysis of microorganisms in:
— 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.
This document specifies the technical stages of the establishment of a new standardized reference method and of the revision of an existing standardized reference method. It includes, in particular, requirements and guidance on the validation of the selected method.
This document is intended to be implemented in particular by ISO/TC 34/SC 9 and its corresponding structure at CEN level, which is CEN/TC 463.
Mikrobiologie der Lebensmittelkette - Technische Anforderungen und Leitfaden zur Einführung oder Überarbeitung von genormten Referenzverfahren (ISO 17468:2023)
In diesem Dokument sind die technischen Anforderungen und ein Leitfaden zur Einführung oder Überarbeitung von genormten Referenzverfahren aufgeführt, die zur Analyse von Mikroorganismen verwendet werden, welche 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
enthalten sind.
Dieses Dokument legt die technischen Stufen der Einführung eines neuen genormten Referenzverfahrens und der Überarbeitung eines bestehenden genormten Referenzverfahrens fest. Es schließt insbesondere Anforderungen an und einen Leitfaden für die Validierung der auszuwählenden Verfahren ein.
Die Umsetzung dieses Dokuments ist insbesondere durch ISO/TC 34/SC 9 und das entsprechende Gremium auf CEN Ebene, CEN/TC 463 vorgesehen.
Microbiologie de la chaîne alimentaire - Exigences et recommandations techniques pour le développement ou la révision d'une méthode de référence normalisée (ISO 17468:2023)
Le présent document établit des exigences et des recommandations techniques pour le développement ou la révision de méthodes de référence normalisées pour l’analyse des micro-organismes dans:
— les produits destinés à la consommation humaine;
— les produits destinés à l’alimentation animale;
— les échantillons environnementaux dans les zones de production et de manipulation des aliments;
— les échantillons prélevés au stade de la production primaire.
Le présent document spécifie les stades techniques du développement d’une nouvelle méthode de référence normalisée et de la révision d’une méthode de référence normalisée existante. Il inclut, en particulier, les exigences et les recommandations applicables à la validation de la méthode sélectionnée.
Le présent document est destiné à être mis en œuvre en particulier par l’ISO/TC 34/SC 9 et sa structure équivalente au niveau du CEN, à savoir le CEN/TC 463.
Mikrobiologija v prehranski verigi - Tehnične zahteve in navodila za vzpostavitev ali revizijo standardnih referenčnih metod (ISO 17468:2023)
Ta dokument podaja tehnične zahteve in navodila za vzpostavitev ali revizijo standardnih referenčnih metod, ki se uporabljajo za analizo mikroorganizmov v:
– proizvodih, namenjenih za prehrano ljudi;
– proizvodih za živalsko krmo;
– okoljskih vzorcih v območju proizvodnje in ravnanja z živili in krmo;
– vzorcih iz faze primarne proizvodnje.
Ta dokument določa tehnične faze vzpostavljanja novih standardnih referenčnih metod ali revizije obstoječe standardizirane referenčne metode. Predvsem vključuje zahteve in navodila za validacijo izbrane metode.
Ta dokument je namenjen izvajanju predvsem s standardom ISO/TC 34/SC 9 in njegovo ustrezno
strukturo na ravni CEN, ki je CEN/TC 463.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-marec-2024
Nadomešča:
SIST EN ISO 17468:2016
Mikrobiologija v prehranski verigi - Tehnične zahteve in navodila za vzpostavitev
ali revizijo standardnih referenčnih metod (ISO 17468:2023)
Microbiology of the food chain - Technical requirements and guidance on the
establishment or revision of a standardized reference method (ISO 17468:2023)
Mikrobiologie der Lebensmittelkette - Technische Anforderungen und Leitfaden zur
Einführung oder Überarbeitung von genormten Referenzverfahren (ISO 17468:2023)
Microbiologie de la chaîne alimentaire - Exigences et recommandations techniques pour
le développement ou la révision d'une méthode de référence normalisée (ISO
17468:2023)
Ta slovenski standard je istoveten z: EN ISO 17468:2023
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 17468
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2023
EUROPÄISCHE NORM
ICS 07.100.30 Supersedes EN ISO 17468:2016
English Version
Microbiology of the food chain - Technical requirements
and guidance on the establishment or revision of a
standardized reference method (ISO 17468:2023)
Microbiologie de la chaîne alimentaire - Exigences et Mikrobiologie der Lebensmittelkette - Technische
recommandations techniques pour le développement Anforderungen und Leitfaden zur Einführung oder
ou la révision d'une méthode de référence normalisée Überarbeitung von genormten Referenzverfahren (ISO
(ISO 17468:2023) 17468:2023)
This European Standard was approved by CEN on 29 September 2023.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a 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 European Standard 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 NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17468:2023 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 17468:2023) 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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by May 2024, and conflicting national standards shall be
withdrawn at the latest by May 2024.
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.
This document supersedes EN ISO 17468:2016.
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 17468:2023 has been approved by CEN as EN ISO 17468:2023 without any modification.
INTERNATIONAL ISO
STANDARD 17468
Second edition
2023-11
Microbiology of the food chain —
Technical requirements and guidance
on the establishment or revision of a
standardized reference method
Microbiologie de la chaîne alimentaire — Exigences et
recommandations techniques pour le développement ou la révision
d'une méthode de référence normalisée
Reference number
ISO 17468:2023(E)
ISO 17468:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 17468:2023(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Technical procedure for standardizing a new reference method.3
4.1 General . 3
4.2 Technical steps . 3
4.2.1 Step 1: Method(s) selection (mandatory) . 3
4.2.2 Step 2: Method(s) optimization (optional) . 4
4.2.3 Step 3: Method(s) evaluation study (recommended) . 4
4.2.4 Step 4: “Real life” study (recommended) . 5
4.2.5 Step 5: Selection of one candidate reference method for further validation
(mandatory) . 5
4.2.6 Step 6: Interlaboratory study (mandatory) . 5
5 Technical procedure for revising a standardized reference method .7
Annex A (informative) Flow chart on technical steps for the establishment or revision of a
standardized reference method.9
Annex B (informative) Guidance on optimization studies to compare two options in the
development of a new standardized reference method or for its revision .10
Bibliography .13
iii
ISO 17468:2023(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 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).
This second edition cancels and replaces the first edition (ISO 17468:2016), which has been technically
revised.
The main changes are as follows:
— a cross-reference is made not only to ISO 16140-2, but also to ISO 16140-4 and ISO 16140-6;
— a new optional step has been added, "method(s) optimization". In addition, a new annex providing
guidance on method optimization studies is included, to compare two options during the development
of a new standardized reference method or for its revision;
— the inclusion of the case of confirmation and typing methods;
— the assessment of the nature of a change (minor/major) during the revision of a standardized
reference method.
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
INTERNATIONAL STANDARD ISO 17468:2023(E)
Microbiology of the food chain — Technical requirements
and guidance on the establishment or revision of a
standardized reference method
1 Scope
This document gives technical requirements and guidance on the establishment or revision of
standardized reference methods used for the analysis of microorganisms in:
— 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.
This document specifies the technical stages of the establishment of a new standardized reference
method and of the revision of an existing standardized reference method. It includes, in particular,
requirements and guidance on the validation of the selected method.
This document is intended to be implemented in particular by ISO/TC 34/SC 9 and its corresponding
structure at CEN level, which is CEN/TC 463.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 5725-2, Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method
for the determin
...
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