EN ISO 21528-1:2017

Microbiology of the food chain - Horizontal method for the detection and enumeration of Enterobacteriaceae - Part 1: Detection of Enterobacteriaceae (ISO 21528-1:2017)

ISO 21528-1:2017 specifies a method, with enrichment, for the detection of Enterobacteriaceae. It is applicable to
-      products intended for human consumption and the feeding of animals, and
-      environmental samples in the area of primary production, food production and food handling.
This method is applicable
-      when the microorganisms sought are expected to need resuscitation by enrichment, and
-      when the number sought is expected to be below 100 per millilitre or per gram of test sample.
A limitation on the applicability of ISO 21528-1:2017 is imposed by the susceptibility of the method to a large degree of variability (see Clause 11).
NOTE       Enumeration can be carried out by calculation of the most probable number (MPN) after incubation in liquid medium. See Annex A.

Mikrobiologie der Lebensmittelkette - Horizontales Verfahren für den Nachweis und die Zählung von Enterobacteriaceae Teil 1: Nachweis von Enterobacteriaceae (ISO 21528-1:2017)

Microbiologie de la chaîne alimentaire - Méthode horizontale par la recherche et le dénombrement des Enterobacteriaceae - Partie 1: Recherche des Enterobacteriaceae (ISO 21528-1:2017)

L'ISO 21528-1:2017 spécifie une méthode pour la recherche des Enterobacteriaceae avec enrichissement. Elle est applicable:
-      aux produits destinés à l'alimentation humaine et animale, et
-      aux échantillons d'environnement pour la production au stade primaire, la production des aliments et la distribution des aliments.
Cette méthode est applicable:
-      lorsque les micro-organismes recherchés nécessitent une revivification par enrichissement, et
-      lorsque le nombre recherché est supposé être inférieur à 100 par millilitre ou par gramme d'échantillon pour essai.
Des limites sont imposées aux possibilités d'application de l'ISO 21528-1:2017 du fait que ces méthodes sont sujettes à de grandes variations (voir l'Article 11).
NOTE       Le dénombrement peut être effectué en calculant le nombre le plus probable (NPP) après incubation en milieu liquide. Voir l'Annexe A.

Mikrobiologija v prehranski verigi - Horizontalna metoda za ugotavljanje prisotnosti in števila enterobakterij - 1. del: Ugotavljanje prisotnosti enterobakterij (ISO 21528-1:2017)

Ta standard določa metodo najverjetnejšega števila (MPN) s predhodno obogatitvijo za ugotavljanje prisotnosti enterobakterij. Uporablja se za:
– izdelke, namenjene za prehrano ljudi in krmo živali; in
– okoljske vzorce na območju proizvodnje hrane in ravnanja s hrano; in
– vzorce iz primarne proizvodnje.
(referenčni dokument: ISO 21528-1)

General Information

• Status: Published
• Publication Date: 04-Jul-2017
• Withdrawal Date: 30-Jan-2018
• 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: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 05-Jul-2017
• Due Date: 01-Mar-2014
• Completion Date: 05-Jul-2017
• Directive: 882/2004 - Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 onofficial controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules
• Mandate: M/381 - Mandate for standardisation addressed to CEN in the field of Methods of analysis of foodstuffs concerning Food Hygiene
• Ref Project: SIST EN ISO 21528-1:2017 - Microbiology of the food chain - Horizontal method for the detection and enumeration of Enterobacteriaceae - Part 1: Detection of Enterobacteriaceae (ISO 21528-1:2017)

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2017
Mikrobiologija v prehranski verigi - Horizontalna metoda za ugotavljanje
prisotnosti in števila enterobakterij - 1. del: Ugotavljanje prisotnosti enterobakterij
(ISO 21528-1:2017)
Microbiology of the food chain - Horizontal method for the detection and enumeration of
Enterobacteriaceae - Part 1: Detection of Enterobacteriaceae (ISO 21528-1:2017)
Mikrobiologie der Lebensmittelkette - Horizontales Verfahren für den Nachweis und die
Zählung von Enterobacteriaceae Teil 1: Nachweis von Enterobacteriaceae (ISO 21528-
1:2017)
Microbiologie de la chaîne alimentaire - Méthode horizontale par la recherche et le
dénombrement des Enterobacteriaceae - Partie 1: Recherche des Enterobacteriaceae
(ISO 21528-1:2017)
Ta slovenski standard je istoveten z: EN ISO 21528-1:2017
ICS:
07.100.30 Mikrobiologija živil Food microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21528-1
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2017
EUROPÄISCHE NORM
ICS 07.100.30
English Version
Microbiology of the food chain - Horizontal method for the
detection and enumeration of Enterobacteriaceae - Part 1:
Detection of Enterobacteriaceae (ISO 21528-1:2017)
Microbiologie de la chaîne alimentaire - Méthode Mikrobiologie der Lebensmittelkette - Horizontales
horizontale par la recherche et le dénombrement des Verfahren für den Nachweis und die Zählung von
Enterobacteriaceae - Partie 1: Recherche des Enterobacteriaceae Teil 1: Nachweis von
Enterobacteriaceae (ISO 21528-1:2017) Enterobacteriaceae (ISO 21528-1:2017)
This European Standard was approved by CEN on 27 April 2017.

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, Serbia, 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
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21528-1:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21528-1:2017) 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 2018, and conflicting national standards shall
be withdrawn at the latest by January 2018.
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 has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21528-1:2017 has been approved by CEN as EN ISO 21528-1:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 21528-1
Second edition
2017-06
Microbiology of the food chain —
Horizontal method for the detection
and enumeration of
Enterobacteriaceae —
Part 1:
Detection of Enterobacteriaceae
Microbiologie de la chaîne alimentaire — Méthode horizontale par
la recherche et le dénombrement des Enterobacteriaceae —
Partie 1: Recherche des Enterobacteriaceae
Reference number
ISO 21528-1:2017(E)
©
ISO 2017
ISO 21528-1:2017(E)
© ISO 2017, 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.
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ii © ISO 2017 – All rights reserved

ISO 21528-1:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 2
4.1 Enrichment in non-selective medium . 2
4.2 Isolation and selection for confirmation . 2
4.3 Confirmation . 2
5 Diluent, culture media and reagent . 2
6 Equipment and consumables . 2
7 Sampling . 3
8 Preparation of test sample . 3
9 Procedure. 3
9.1 General . 3
9.2 Test portion and initial suspension . 4
9.3 Enrichment . 4
9.4 Isolation and selection for confirmation . 4
9.4.1 Isolation . 4
9.4.2 Selection of colonies for confirmation . 4
9.5 Subculturing selected colonies. 4
9.6 Biochemical confirmation tests . 4
9.6.1 Oxidase reaction . 4
9.6.2 Fermentation test . 5
10 Expression of results . 5
11 Precision . 5
11.1 Interlaboratory study . 5
11.2 Sensitivity . 5
11.3 Specificity . 5
12 Test report . 5
13 Quality assurance . 6
Annex A (informative) Enumeration by MPN technique . 7
Annex B (normative) Culture media and reagents .10
Annex C (informative) Method validation studies and performance characteristics .15
Bibliography .17
ISO 21528-1:2017(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
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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 t
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