EN ISO 17468:2016

Microbiology of the food chain - Technical requirements and guidance on establishment or revision of a standardized reference method (ISO 17468:2016)

ISO 17468:2016 gives technical requirements and guidance on the establishment or revision of standardized reference methods for the analysis (detection or quantification) of microorganisms in
-      products intended for human consumption and for the feeding of animals,
-      environmental samples in the area of food/feed production and food/feed handling, and
-      samples from the primary production stage.
It defines the technical stage (or early stage) of the establishment of a new standardized reference method or of the revision of an existing standardized reference method. It includes, in particular, requirements and guidance on the validation of the selected method.
It is intended to be implemented in particular by ISO/TC 34/SC 9 and its corresponding structure at CEN level, CEN/TC 275, Food analysis - Horizontal methods, Working Group 6, Microbiology of the food chain.

Mikrobiologie der Lebensmittelkette - Technische Anforderungen und Leitfaden zur Einführung oder Überarbeitung von Standardverfahren (ISO 17468:2016)

In dieser Internationalen Norm sind die technischen Anforderungen und ein Leitfaden zur Einführung oder Überarbeitung von genormten Referenzverfahren zur Analyse (Nachweis oder quantitative Bestimmung) von Mikroorganismen in
   Erzeugnissen, die für den menschlichen Verzehr und als Futtermittel vorgesehen sind,
   Umgebungsproben im Bereich der Herstellung und Handhabung von Lebensmitteln/Futtermittel, und
   Proben aus dem Bereich der Primärproduktion
angeführt.
Diese Internationale Norm legt die technische Stufe (oder Anfangsstufe) der Einführung eines neuen genormten Referenzverfahrens oder der Überarbeitung eines bestehenden genormten Referenzverfahrens fest. Sie schließt insbesondere Anforderungen an und einen Leitfaden für die Validierung der auszu-wählenden Verfahren ein.
Diese Internationale Norm ist vorgesehen, insbesondere durch ISO/TC 34/SC 9 und dem entsprechenden Gremium auf CEN Ebene, CEN/TC 275, Lebensmittelanalytik — Horizontale Verfahren, Arbeitsgruppe 6 (en: Working Group 6, WG 6),  Mikrobiologie der Lebensmittelkette, umgesetzt zu werden.

Microbiologie de la chaîne alimentaire - Exigences et recommandations techniques pour le développement ou la révision d'une méthode de référence normalisée (ISO 17468:2016)

L'ISO 17468 :2016 fournit les exigences et recommandations techniques pour le développement ou la révision de méthodes de référence normalisées pour l'analyse (détection ou quantification) des microorganismes dans:
-      les produits destinés à la consommation humaine ou animale;
-      les échantillons d'environnement prélevés dans les zones de production et de manipulation des aliments;
-      les échantillons prélevés au stade de production primaire.
Elle définit le stade technique (ou stade précoce) du développement d'une nouvelle méthode de référence normalisée ou de la révision d'une méthode de référence normalisée existante. Elle inclut, en particulier, les exigences et les recommandations applicables à la validation de la méthode sélectionnée.
Elle est destinée à être mise en ?uvre en particulier par l'ISO/TC 34/SC 9 et sa structure équivalente au niveau du CEN, CEN/TC 275, Analyse des produits alimentaires - Méthodes horizontales, Groupe de travail 6, Microbiologie de la chaîne alimentaire.

Mikrobiologija v prehranski verigi - Tehnične zahteve in navodila za vzpostavitev ali revizijo standardnih referenčnih metod (ISO 17468:2016)

Ta standard podaja napotke za validacijo referenčnih metod na področju mikrobiološke analize hrane, živalske krme, veterinarskih vzorcev in okolja za proizvodnjo hrane za: – validacijo novih referenčnih metod; – validacijo revizij referenčnih metod, ki se trenutno uporabljajo. Ta standard podrobno opisuje predstandardizacijsko fazo (zgodnjo fazo) vzpostavljanja novih standardnih referenčnih metod ali revizije obstoječe referenčne metode (dodatka A in B). Ta dokument je namenjen zlasti za standardizacijo referenčnih metod v okviru odgovornosti v skladu s standardom CEN/TC 275.

General Information

• Status: Withdrawn
• Publication Date: 19-Jul-2016
• Withdrawal Date: 21-Nov-2023
• 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
• Ref Project: SIST EN ISO 17468:2016 - Microbiology of the food chain - Technical requirements and guidance on establishment or revision of a standardized reference method (ISO 17468:2016)

Relations

• Replaced By: EN 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)
• Effective Date: 18-Jan-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-oktober-2016
0LNURELRORJLMDYSUHKUDQVNLYHULJL7HKQLþQH]DKWHYHLQQDYRGLOD]DY]SRVWDYLWHY
DOLUHYL]LMRVWDQGDUGQLKUHIHUHQþQLKPHWRG,62
Microbiology of the food chain - Technical requirements and guidance on establishment
or revision of a standardized reference method (ISO 17468:2016)
Mikrobiologie der Lebensmittelkette - Technische Anforderungen und Leitfaden zur
Einführung oder Überarbeitung von Standardverfahren (ISO 17468:2016)
Microbiologie de la chaîne alimentaire - Exigences et recommandations techniques pour
le développement ou la révision d'une méthode de référence normalisée (ISO
17468:2016)
Ta slovenski standard je istoveten z: EN ISO 17468:2016
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
July 2016
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Technical requirements
and guidance on establishment or revision of a
standardized reference method (ISO 17468:2016)
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 Standardverfahren (ISO
(ISO 17468:2016) 17468:2016)
This European Standard was approved by CEN on 20 June 2015.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17468:2016 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
European foreword
This document (EN ISO 17468:2016) has been prepared by Technical Committee ISO/TC 34 "Food
products" in collaboration with Technical Committee CEN/TC 275 “Food analysis - Horizontal methods”
the secretariat of which is held by DIN.
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 January 2017, and conflicting national standards shall
be withdrawn at the latest by January 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 17468:2016 has been approved by CEN as EN ISO 17468:2016 without any modification.

INTERNATIONAL ISO
STANDARD 17468
First edition
2016-06-15
Microbiology of the food chain —
Technical requirements and guidance
on 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 17468:2016(E)
©
ISO 2016
ISO 17468:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. [phone]
Fax [phone]
[e-mail]
www.iso.org
ii © ISO 2016 – All rights reserved

ISO 17468:2016(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Technical procedure for standardizing a new reference method . 2
4.1 General . 2
4.2 Technical steps . 2
4.2.1 Step 1: Method(s) selection . 2
4.2.2 Step 2: Method(s) evaluation study . 2
4.2.3 Step 3: “Real life”/multilaboratory study . 3
4.2.4 Step 4: Selection of method for further validation . 3
4.2.5 Step 5: Interlaboratory study . 3
5 Technical procedure for revising a standardized reference method .4
5.1 General . 4
5.2 Impact of reference method revision on the existing validation of alternative methods . 4
Annex A (normative) Flow chart on technical steps for the establishment or revision of a
standardized reference method . 5
ISO 17468:2016(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 34, Food products, Subcommittee SC 9,
Microbiology.
iv © ISO 2016 – All rights reserved

ISO 17468:2016(E)
Introduction
This International Standard has been developed in order to set common rules for the validation
of reference methods standardized in the field of food microbiology by ISO/TC 34, Food products,
Subcommittee SC 9, Microbiology, and its corresponding structure at CEN level (CEN/TC 275, Food
analysis — Horizontal methods, Working Group 6, Microbiology of the food chain).
This International Standard refers to the complete process of method validation, including comparison
of performance data to predetermined criteria/acceptability values. These values are not set in the
present edition of this International Standard, due to the lack of available data.
INTERNATIONAL STANDARD ISO 17468:2016(E)
Microbiology of the food chain — Technical requirements
and guidance on establishment or revision of a
standardized reference method
1 Scope
This International Standard gives technical requirements and guidance on the establishment or revision
of standardized reference methods for the analysis (detection or quantification) of microorganisms in
— products intended for human consumption and for the feeding of animals,
— environmental samples in the area of food/feed production and food/feed handling, and
— samples from the primary production stage.
This International Standard defines the technical stage (or early stage) of the establishment of a new
standardized reference method or of the revision of an existing standardized reference method. It
includes, in particular, requirements and guidance on the validation of the selected method.
This International Standard is intended to be implemented in particular by ISO/TC 34/SC 9 and its
corresponding structure at CEN level, CEN/TC 275, Food analysis — Horizontal methods, Working
Group 6, Microbiology of the food chain.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable to its application For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 16140-1, Microbiology of the food chain — Method validation — Part 1: Vocabulary
ISO 16140-2:2016, Microbiology of the food chain — Method validation — Part 2: Protocol for the validation
of alternative (proprietary) methods against a reference method
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 16140-1 and the following apply.
3.1
candidate reference method
method selected and likely to become the standardized reference method (3.5)
3.2
multilaboratory study
study of one or several methods conducted in different laboratories, using their own samples analysed
in routine
3.3
prestandardization stage
technical stage prior to standardization stage and comprising different steps described in this
International Standard
Note 1 to entry: Standardization stage starts with voting on a New Work Item Proposal for inclu
...