SIST EN ISO 11133:2014
(Main)Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of culture media (ISO 11133:2014)
Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of culture media (ISO 11133:2014)
EN ISO 11133 defines terms related to quality assurance of culture media and specifies the requirements for the preparation of culture media intended for the microbiological analysis of food, animal feed, and samples from the food or feed production environment as well as all kinds of water intended for consumption or used in food production. These requirements are applicable to all categories of culture media prepared for use in laboratories performing microbiological analyses. This International Standard also sets criteria and describes methods for the performance testing of culture media. This International Standard applies to producers such as: - commercial bodies producing and/or distributing ready-to-use or semi-finished reconstituted or dehydrated media; - non-commercial bodies supplying media to third parties; - microbiological laboratories preparing culture media for their own use.
Mikrobiologie von Lebensmitteln, Futtermitteln und Wasser - Vorbereitung, Herstellung, Lagerung und Leistungsprüfung von Nährmedien (ISO 11133:2014)
Diese Internationale Norm enthält die allgemeine Terminologie hinsichtlich der Qualitätssicherung und legt die Anforderungen an die Zubereitung von Nährmedien fest, die für mikrobiologische Untersuchungen von Produkten zu verwenden sind, die für den menschlichen Verzehr oder als Futtermittel vorgesehen sind, von Umgebungsproben aus der Lebensmittelproduktion sowie aller Arten von Wasser.
Diese Anforderungen gelten für folgende vier Arten von in Laboratorien verwendeten Nährmedien; wobei das Laboratorium für die mikrobiologischen Untersuchungen Nährmedien herstellt und/oder verwendet:
- gewerblich hergestellte Fertigmedien;
- gewerblich hergestellte Medien, die erneut zu verflüssigen, zu supplementieren und abzufüllen sind;
- aus handelsüblichen Trockenformulierungen hergestellte Medien;
- aus einzelnen Grundsubstanzen hergestellte Medien.
Diese Internationale Norm legt außerdem Kriterien fest und beschreibt Verfahren für die Leistungsprüfung von Nährmedien. Diese Internationale Norm gilt für:
- kommerzielle Einrichtungen, die gebrauchsfertig zubereitete Medien, Halbfertigmedien oder Trockenmedien herstellen und/oder vertreiben;
- nichtkommerzielle Einrichtungen, die Medien an Dritte liefern;
- mikrobiologische Laboratorien, die Nährmedien für ihre eigene Verwendung herstellen.
Microbiologie des aliments, des aliments pour animaux et de l'eau - Préparation, production, stockage et essais de performance des milieux de culture (ISO 11133:2014)
L'ISO 11133:2014 définit les termes relatifs à l'assurance qualité des milieux de culture et spécifie les exigences relatives à la préparation des milieux de culture destinés à être appliqués pour l'analyse microbiologique des aliments, des aliments pour animaux et des d'échantillons de la production d'aliments et d'aliments pour animaux ainsi que de tous les types d'eau destinés à la consommation ou utilisés dans la production alimentaire. Ces exigences sont applicables à toutes catégories de milieux de culture préparés pour être utilisés dans les laboratoires qui réalisent des analyses microbiologiques.
L'ISO 11133:2014 définit également des critères et décrit des méthodes pour les essais de performance des milieux de culture. Elle s'applique aux producteurs tels que:
les entités commerciales qui produisent et/ou distribuent des milieux prêts à l'emploi, semi-finis reconstitués ou déshydratés;
les entités non commerciales qui fournissent des milieux à des tiers;
les laboratoires de microbiologie qui préparent des milieux de culture pour leur propre usage.
Mikrobiologija živil, krme in vode - Priprava, izdelava, skladiščenje in preskušanje lastnosti gojišč (ISO 11133:2014)
Standard EN ISO 11133 določa izraze, povezane z zagotavljanjem kakovosti gojišč, in opredeljuje zahteve za pripravo gojišč, namenjenih mikrobiološki analizi živil, krme in vzorcev iz proizvodnega okolja živil ali krme ter tudi vseh vrst vode, namenjene pitju ali uporabi pri proizvodnji živil. Te zahteve se uporabljajo za vse kategorije gojišč, pripravljenih za uporabo v laboratorijih, ki izvajajo mikrobiološke analize. Ta mednarodni standard določa tudi merila in opisuje metode za preskušanje lastnosti gojišč. Ta mednarodni standard se uporablja za proizvajalce, kot so: – komercialni organi, ki proizvajajo in/ali distribuirajo na uporabo pripravljena ali polpripravljena rekonstituirana ali dehidrirana gojišča; – nekomercialni organi, ki gojišča dobavljajo tretjim strankam; – mikrobiološki laboratoriji, ki pripravljajo gojišča za lastno uporabo.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11133:2014
01-oktober-2014
Nadomešča:
SIST ISO 9998:1998
SIST-TS CEN ISO/TS 11133-1:2009
SIST-TS CEN ISO/TS 11133-2:2004
SIST-TS CEN ISO/TS 11133-2:2004/A1:2011
Mikrobiologija živil, krme in vode - Priprava, izdelava, skladiščenje in preskušanje
lastnosti gojišč (ISO 11133:2014)
Microbiology of food, animal feed and water - Preparation, production, storage and
performance testing of culture media (ISO 11133:2014)
Mikrobiologie von Lebensmitteln, Futtermitteln und Wasser - Vorbereitung, Herstellung,
Lagerung und Leistungsprüfung von Nährmedien (ISO 11133:2014)
Microbiologie des aliments, des aliments pour animaux et de l'eau - Préparation,
production, stockage et essais de performance des milieux de culture (ISO 11133:2014)
Ta slovenski standard je istoveten z: EN ISO 11133:2014
ICS:
07.100.20 Mikrobiologija vode Microbiology of water
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 11133:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11133:2014
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SIST EN ISO 11133:2014
EUROPEAN STANDARD
EN ISO 11133
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2014
ICS 07.100.30 Supersedes CEN ISO/TS 11133-1:2009, CEN ISO/TS
11133-2:2003
English Version
Microbiology of food, animal feed and water - Preparation,
production, storage and performance testing of culture media
(ISO 11133:2014, Corrected version 2014-11-01)
Microbiologie des aliments, des aliments pour animaux et Mikrobiologie von Lebensmitteln, Futtermitteln und Wasser
de l'eau - Préparation, production, stockage et essais de - Vorbereitung, Herstellung, Lagerung und
performance des milieux de culture (ISO 11133:2014, Leistungsprüfung von Nährmedien (ISO 11133:2014,
Version corrigée 2014-11-01) korrigierte Fassung 2014-11-01)
This European Standard was approved by CEN on 20 March 2014.
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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11133:2014 E
worldwide for CEN national Members.
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SIST EN ISO 11133:2014
EN ISO 11133:2014 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11133:2014
EN ISO 11133:2014 (E)
Foreword
This document (EN ISO 11133:2014) 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 November 2014, and conflicting national standards shall be withdrawn
at the latest by November 2014.
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.
This document supersedes CEN ISO/TS 11133-2:2003, CEN ISO/TS 11133-1:2009.
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 11133:2014, Corrected version 2014-11-01 has been approved by CEN as
EN ISO 11133:2014 without any modification.
3
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SIST EN ISO 11133:2014
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SIST EN ISO 11133:2014
INTERNATIONAL ISO
STANDARD 11133
First edition
2014-05-15
Microbiology of food, animal feed and
water — Preparation, production,
storage and performance testing of
culture media
Microbiologie des aliments, des aliments pour animaux et de l’eau —
Préparation, production, stockage et essais de performance des
milieux de culture
Reference number
ISO 11133:2014(E)
©
ISO 2014
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
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
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 General terms and definitions . 2
3.2 Terminology of performance testing . 2
3.3 Terminology of culture media . 3
3.4 Terminology for test microorganisms . 6
4 Quality assurance management . 7
4.1 Documentation . 7
4.2 Storage . 8
4.3 Laboratory preparation of media . 8
4.4 Storage and shelf-life of prepared media .11
4.5 Preparation for use .12
4.6 Incubation of solid media in Petri dishes .14
4.7 Disposal of media .14
5 Test organisms for performance testing.14
5.1 General .14
5.2 Selection of test organisms .14
5.3 Preservation and maintenance of test organisms .15
5.4 Microorganisms for performance testing .16
6 Quality control and performance testing of culture media .19
6.1 General requirements .19
6.2 Physical and chemical quality control .19
6.3 Microbiological quality control .19
6.4 General requirements for microbiological performance testing .20
6.5 Performance evaluation and interpretation of results .21
6.6 Confirmation media and reagents .22
7 Methods for performance testing of solid culture media .22
7.1 General .22
7.2 Methods for quantitative tests.22
7.3 Testing of culture media used for membrane filtration .24
7.4 Methods for qualitative tests .24
8 Methods for performance testing of liquid culture media.25
8.1 General .25
8.2 Quantitative tube method for performance testing of liquid enrichment media (dilution to
extinction method) .25
8.3 Qualitative tube method for performance testing of selective liquid media .26
8.4 Qualitative single tube method (turbidity) for performance testing of liquid media .27
9 Methods for performance testing of diluents and transport media .28
9.1 General .28
9.2 Method for testing diluents .28
9.3 Method for testing transport media .29
10 Documentation of test results .30
10.1 Information provided by the manufacturer .30
10.2 Traceability .30
Annex A (informative) Designation of the components of culture media in International Standards
on microbiological analysis of food, animal feed and water .31
© ISO 2014 – All rights reserved iii
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
Annex B (normative) Preparation of reference stock and working culture .33
Annex C (normative) Flow charts of methods for performance testing .38
Annex D (informative) Example of card for recording test results of culture media .42
Annex E (normative) Test microorganisms and performance criteria for culture media commonly
used in food microbiology .44
Annex F (normative) Test microorganisms and performance criteria for culture media commonly
used in water microbiology.62
Annex G (normative) Use of control charts to monitor quantitative testing of solid
culture media .73
Annex H (informative) Quality assurance of culture media — Troubleshooting .80
Annex I (informative) Quantitative testing of liquid media .82
Annex J (normative) Definition of microbiological performance tests for standardized
culture media .86
Bibliography .90
iv © ISO 2014 – All rights reserved
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SIST EN ISO 11133:2014
ISO 11133:2014(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. 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. 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, Food
products, in collaboration with Technical Committee ISO/TC 147 Water quality, Subcommittee SC 4,
Microbiological methods.
This first edition of ISO 11133 replaces the second edition of ISO/TS 11133-1 (ISO/TS 11133-1:2009)
and the first edition of ISO/TS 11133-2:2003, which have been technically revised. It also incorporates
the Amendment ISO/TS 11133-2:2003/Amd.1:2011. In particular, it also includes requirements for
microbiology media for water testing. It supersedes ISO 9998:1991.
© ISO 2014 – All rights reserved v
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
Introduction
In laboratories carrying out microbiological examinations, the main objectives are to maintain,
resuscitate, grow, detect and/or enumerate a wide variety of microorganisms. Culture media are used
in all traditional microbiological culture techniques and also for many alternative techniques. Many
formulae of culture media are commercially available and many more, designed for specific growth
purposes, are described in the literature.
Many tests and procedures depend upon culture media being capable of providing consistent and
reproducible results. The requirements for media may be specific to both the sample and the organisms
to be detected. Culture media meeting established performance criteria are therefore a pre-requisite for
any reliable microbiological work. Sufficient testing should be carried out to demonstrate
a) the acceptability of each batch of medium,
b) that the medium is “fit for purpose”, and
c) that the medium can produce consistent results.
These three criteria are an essential part of internal quality control procedures and, with appropriate
documentation, will permit effective monitoring of culture media and contribute to the production of
both accurate and reliable data. For reliable microbiological analysis it is essential to use culture media
of proven quality. For all media described in standard methods it is essential to define the minimum
acceptance criteria required to ensure their reliability. It is recommended that in the determination
of the performance characteristics of a culture medium tests are carried out that conform with this
International Standard.
The establishment of widely accepted minimum performance criteria for media should lead to products
with more consistent quality and thus reduce the extent of testing necessary in the user’s laboratory.
In addition the acceptance criteria measured by the methods defined in this International Standard
can be used by all microbiological laboratories to evaluate the productive, selective and/or elective
properties of a culture medium.
In the microbiological analysis of food, animal feed and water, the requirements of this International
Standard have precedence in the assessment of culture media quality.
vi © ISO 2014 – All rights reserved
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SIST EN ISO 11133:2014
INTERNATIONAL STANDARD ISO 11133:2014(E)
Microbiology of food, animal feed and water —
Preparation, production, storage and performance testing
of culture media
1 Scope
This International Standard defines terms related to quality assurance of culture media and specifies
the requirements for the preparation of culture media intended for the microbiological analysis of food,
animal feed, and samples from the food or feed production environment as well as all kinds of water
intended for consumption or used in food production.
These requirements are applicable to all categories of culture media prepared for use in laboratories
performing microbiological analyses.
This International Standard also sets criteria and describes methods for the performance testing of
culture media. This International Standard applies to producers such as:
— commercial bodies producing and/or distributing ready-to-use or semi-finished reconstituted or
dehydrated media;
— non-commercial bodies supplying media to third parties;
— microbiological laboratories preparing culture media for their own use.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for 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 6887-1, Microbiology of food and animal feed — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination — Part 1: General rules for the preparation of the initial
suspension and decimal dilutions
ISO 6887-2, Microbiology of food and animal feed — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination — Part 2: Specific rules for the preparation of meat and
meat products
ISO 6887-3, Microbiology of food and animal feed — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination — Part 3: Specific rules for the preparation of fish and
fishery products
ISO 6887-4, Microbiology of food and animal feed — Preparation of test samples, initial suspension
and decimal dilutions for microbiological examination — Part 4: Specific rules for the preparation of
miscellaneous products
ISO 6887-5, Microbiology of food and animal feeding stuffs — Preparation of test samples, initial suspension
and decimal dilutions for microbiological examination — Part 5: Specific rules for the preparation of milk
and milk products
ISO 6887-6, Microbiology of food and animal feed — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination — Part 6: Specific rules for the preparation of samples
taken at the primary production stage
ISO 7704, Water quality — Evaluation of membrane filters used for microbiological analyses
© ISO 2014 – All rights reserved 1
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
ISO 7218, Microbiology of food and animal feeding stuffs — General requirements and guidance for
microbiological examinations
ISO 8199, Water quality — General guidance on the enumeration of micro-organisms by culture
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE 1 This clause gives the general definitions relating to quality assurance of culture media and provides
terminology relating to performance testing, culture media and test microorganisms.
NOTE 2 Tables E.2 and F.2 give explanations of media name abbreviated terms.
3.1 General terms and definitions
3.1.1
quality control
part of quality management focused on fulfilling quality requirements
Note 1 to entry: See Reference [1].
3.1.2
batch of culture medium
lot of culture medium
homogeneous and fully traceable unit of a medium referring to a defined amount of bulk, semi-finished
product or end product, which is consistent in type and quality and which has been produced within one
defined production period, having been assigned the same batch (or lot) number
3.1.3
chromogenic substrate
fluorogenic substrate
substrate containing a chromophore/fluorophore group and a substrate utilizable by bacteria or fungi
Note 1 to entry: After splitting the chromogenic/fluorogenic substrate, the chromophore/fluorophore is released
and a coloured/fluorescent end product becomes visible/can be detected using an ultraviolet (UV) lamp.
3.2 Terminology of performance testing
3.2.1
performance of culture medium
response of a culture medium to challenge by test organisms under defined conditions
3.2.2
target microorganism
microorganism or group of microorganisms to be detected or enumerated
3.2.3
non-target microorganism
microorganism that is suppressed by the medium and/or conditions of incubation or does not show
expected characteristics of the target microorganism
3.2.4
productivity of culture medium
level of recovery of a target microorganism from the culture medium under defined conditions
3.2.5
selectivity of culture medium
degree of inhibition of a non-target microorganism on or in a selective culture medium under defined
conditions
2 © ISO 2014 – All rights reserved
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
3.2.6
electivity of culture medium
specificity of culture medium
demonstration, under defined conditions, that non-target microorganisms do not show the same visual
characteristics as target microorganisms
3.3 Terminology of culture media
3.3.1
culture medium
formulation of substances, in liquid, semi-solid or solid form, which contain natural and/or
synthetic constituents intended to support the multiplication, (with or without inhibition of certain
microorganisms), identification or preservation of viability of microorganisms
Note 1 to entry: When used in connection with compound words, this term is often shortened to read “medium”
(e.g. enrichment medium).
3.3.2 Culture media classified by composition
3.3.2.1
chemically defined medium
culture medium consisting only of chemically defined constituents of known molecular structure and
degree of purity
3.3.2.2
chemically undefined or partially undefined medium
culture medium consisting entirely or partly of natural materials, processed or otherwise, the chemical
composition of which is not completely defined
Note 1 to entry: Harmonized designations for various chemically undefined components used in culture media
are specified in Annex A.
3.3.2.3
chromogenic culture medium
fluorogenic culture medium
culture medium containing one or more chromogenic/fluorogenic substrates
Note 1 to entry: Chromogenic culture media facilitate the identification of bacteria or fungi by means of
defined colour and morphological characteristics (culture medium typical growth). Fluorogenic media require
visualization using a UV lamp. The biochemical reaction products, which are necessary for the efficiency of
chromogenic/fluorogenic culture media, are normally the result of the enzymatic activity of certain organisms,
which in turn depends greatly on the precise maintenance of specific conditions (e.g. temperature, pH value,
concentrations of substrate).
3.3.3 Culture media classified by physical consistency
3.3
...
SLOVENSKI STANDARD
SIST EN ISO 11133:2014
01-oktober-2014
1DGRPHãþD
SIST-TS CEN ISO/TS 11133-1:2009
SIST-TS CEN ISO/TS 11133-2:2004
SIST-TS CEN ISO/TS 11133-2:2004/A1:2011
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Microbiology of food, animal feed and water - Preparation, production, storage and
performance testing of culture media (ISO 11133:2014)
Mikrobiologie von Lebensmitteln, Futtermitteln und Wasser - Vorbereitung, Herstellung,
Lagerung und Leistungsprüfung von Nährmedien (ISO 11133:2014)
Microbiologie des aliments, des aliments pour animaux et de l'eau - Préparation,
production, stockage et essais de performance des milieux de culture (ISO 11133:2014)
Ta slovenski standard je istoveten z: EN ISO 11133:2014
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST EN ISO 11133:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11133:2014
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SIST EN ISO 11133:2014
EUROPEAN STANDARD
EN ISO 11133
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2014
ICS 07.100.30 Supersedes CEN ISO/TS 11133-1:2009, CEN ISO/TS
11133-2:2003
English Version
Microbiology of food, animal feed and water - Preparation,
production, storage and performance testing of culture media
(ISO 11133:2014)
Microbiologie des aliments, des aliments pour animaux et Mikrobiologie von Lebensmitteln, Futtermitteln und Wasser
de l'eau - Préparation, production, stockage et essais de - Vorbereitung, Herstellung, Lagerung und
performance des milieux de culture (ISO 11133:2014) Leistungsprüfung von Nährmedien (ISO 11133:2014)
This European Standard was approved by CEN on 20 March 2014.
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
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11133:2014 E
worldwide for CEN national Members.
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SIST EN ISO 11133:2014
EN ISO 11133:2014 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 11133:2014
EN ISO 11133:2014 (E)
Foreword
This document (EN ISO 11133:2014) 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 November 2014, and conflicting national standards shall be withdrawn
at the latest by November 2014.
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.
This document supersedes CEN ISO/TS 11133-2:2003, CEN ISO/TS 11133-1:2009.
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 11133:2014 has been approved by CEN as EN ISO 11133:2014 without any modification.
3
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SIST EN ISO 11133:2014
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SIST EN ISO 11133:2014
INTERNATIONAL ISO
STANDARD 11133
First edition
2014-05-15
Microbiology of food, animal feed and
water — Preparation, production,
storage and performance testing of
culture media
Microbiologie des aliments, des aliments pour animaux et de l’eau —
Préparation, production, stockage et essais de performance des
milieux de culture
Reference number
ISO 11133:2014(E)
©
ISO 2014
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2014
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
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Published in Switzerland
ii © ISO 2014 – All rights reserved
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
3.1 General terms and definitions . 2
3.2 Terminology of performance testing . 2
3.3 Terminology of culture media . 3
3.4 Terminology for test microorganisms . 6
4 Quality assurance management . 7
4.1 Documentation . 7
4.2 Storage . 8
4.3 Laboratory preparation of media . 8
4.4 Storage and shelf-life of prepared media .11
4.5 Preparation for use .12
4.6 Incubation of solid media in Petri dishes .14
4.7 Disposal of media .14
5 Test organisms for performance testing.14
5.1 General .14
5.2 Selection of test organisms .14
5.3 Preservation and maintenance of test organisms .15
5.4 Microorganisms for performance testing .16
6 Quality control and performance testing of culture media .19
6.1 General requirements .19
6.2 Physical and chemical quality control .19
6.3 Microbiological quality control .19
6.4 General requirements for microbiological performance testing .20
6.5 Performance evaluation and interpretation of results .21
6.6 Confirmation media and reagents .22
7 Methods for performance testing of solid culture media .22
7.1 General .22
7.2 Methods for quantitative tests.22
7.3 Testing of culture media used for membrane filtration .24
7.4 Methods for qualitative tests .24
8 Methods for performance testing of liquid culture media.25
8.1 General .25
8.2 Quantitative tube method for performance testing of liquid enrichment media (dilution to
extinction method) .25
8.3 Qualitative tube method for performance testing of selective liquid media .26
8.4 Qualitative single tube method (turbidity) for performance testing of liquid media .27
9 Methods for performance testing of diluents and transport media .28
9.1 General .28
9.2 Method for testing diluents .28
9.3 Method for testing transport media .29
10 Documentation of test results .30
10.1 Information provided by the manufacturer .30
10.2 Traceability .30
Annex A (informative) Designation of the components of culture media in International Standards
on microbiological analysis of food, animal feed and water .31
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
Annex B (normative) Preparation of reference stock and working culture .33
Annex C (normative) Flow charts of methods for performance testing .38
Annex D (informative) Example of card for recording test results of culture media .42
Annex E (normative) Test microorganisms and performance criteria for culture media commonly
used in food microbiology .44
Annex F (normative) Test microorganisms and performance criteria for culture media commonly
used in water microbiology.62
Annex G (normative) Use of control charts to monitor quantitative testing of solid
culture media .73
Annex H (informative) Quality assurance of culture media — Troubleshooting .80
Annex I (informative) Quantitative testing of liquid media .82
Annex J (normative) Definition of microbiological performance tests for standardized
culture media .86
Bibliography .90
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SIST EN ISO 11133:2014
ISO 11133:2014(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. 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. 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, Food
products, in collaboration with Technical Committee ISO/TC 147 Water quality, Subcommittee SC 4,
Microbiological methods.
This first edition of ISO 11133 replaces the second edition of ISO/TS 11133-1 (ISO/TS 11133-1:2009)
and the first edition of ISO/TS 11133-2:2003, which have been technically revised. It also incorporates
the Amendment ISO/TS 11133-2:2003/Amd.1:2011. In particular, it also includes requirements for
microbiology media for water testing. It supersedes ISO 9998:1991.
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
Introduction
In laboratories carrying out microbiological examinations, the main objectives are to maintain,
resuscitate, grow, detect and/or enumerate a wide variety of microorganisms. Culture media are used
in all traditional microbiological culture techniques and also for many alternative techniques. Many
formulae of culture media are commercially available and many more, designed for specific growth
purposes, are described in the literature.
Many tests and procedures depend upon culture media being capable of providing consistent and
reproducible results. The requirements for media may be specific to both the sample and the organisms
to be detected. Culture media meeting established performance criteria are therefore a pre-requisite for
any reliable microbiological work. Sufficient testing should be carried out to demonstrate
a) the acceptability of each batch of medium,
b) that the medium is “fit for purpose”, and
c) that the medium can produce consistent results.
These three criteria are an essential part of internal quality control procedures and, with appropriate
documentation, will permit effective monitoring of culture media and contribute to the production of
both accurate and reliable data. For reliable microbiological analysis it is essential to use culture media
of proven quality. For all media described in standard methods it is essential to define the minimum
acceptance criteria required to ensure their reliability. It is recommended that in the determination
of the performance characteristics of a culture medium tests are carried out that conform with this
International Standard.
The establishment of widely accepted minimum performance criteria for media should lead to products
with more consistent quality and thus reduce the extent of testing necessary in the user’s laboratory.
In addition the acceptance criteria measured by the methods defined in this International Standard
can be used by all microbiological laboratories to evaluate the productive, selective and/or elective
properties of a culture medium.
In the microbiological analysis of food, animal feed and water, the requirements of this International
Standard have precedence in the assessment of culture media quality.
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SIST EN ISO 11133:2014
INTERNATIONAL STANDARD ISO 11133:2014(E)
Microbiology of food, animal feed and water —
Preparation, production, storage and performance testing
of culture media
1 Scope
This International Standard defines terms related to quality assurance of culture media and specifies
the requirements for the preparation of culture media intended for the microbiological analysis of food,
animal feed, and samples from the food or feed production environment as well as all kinds of water
intended for consumption or used in food production.
These requirements are applicable to all categories of culture media prepared for use in laboratories
performing microbiological analyses.
This International Standard also sets criteria and describes methods for the performance testing of
culture media. This International Standard applies to producers such as:
— commercial bodies producing and/or distributing ready-to-use or semi-finished reconstituted or
dehydrated media;
— non-commercial bodies supplying media to third parties;
— microbiological laboratories preparing culture media for their own use.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for 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 6887-1, Microbiology of food and animal feed — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination — Part 1: General rules for the preparation of the initial
suspension and decimal dilutions
ISO 6887-2, Microbiology of food and animal feed — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination — Part 2: Specific rules for the preparation of meat and
meat products
ISO 6887-3, Microbiology of food and animal feed — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination — Part 3: Specific rules for the preparation of fish and
fishery products
ISO 6887-4, Microbiology of food and animal feed — Preparation of test samples, initial suspension
and decimal dilutions for microbiological examination — Part 4: Specific rules for the preparation of
miscellaneous products
ISO 6887-5, Microbiology of food and animal feeding stuffs — Preparation of test samples, initial suspension
and decimal dilutions for microbiological examination — Part 5: Specific rules for the preparation of milk
and milk products
ISO 6887-6, Microbiology of food and animal feed — Preparation of test samples, initial suspension and
decimal dilutions for microbiological examination — Part 6: Specific rules for the preparation of samples
taken at the primary production stage
ISO 7704, Water quality — Evaluation of membrane filters used for microbiological analyses
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
ISO 7218, Microbiology of food and animal feeding stuffs — General requirements and guidance for
microbiological examinations
ISO 8199, Water quality — General guidance on the enumeration of micro-organisms by culture
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
NOTE 1 This clause gives the general definitions relating to quality assurance of culture media and provides
terminology relating to performance testing, culture media and test microorganisms.
NOTE 2 Tables E.2 and F.2 give explanations of media name abbreviated terms.
3.1 General terms and definitions
3.1.1
quality control
part of quality management focused on fulfilling quality requirements
Note 1 to entry: See Reference [1].
3.1.2
batch of culture medium
lot of culture medium
homogeneous and fully traceable unit of a medium referring to a defined amount of bulk, semi-finished
product or end product, which is consistent in type and quality and which has been produced within one
defined production period, having been assigned the same batch (or lot) number
3.1.3
chromogenic substrate
fluorogenic substrate
substrate containing a chromophore/fluorophore group and a substrate utilizable by bacteria or fungi
Note 1 to entry: After splitting the chromogenic/fluorogenic substrate, the chromophore/fluorophore is released
and a coloured/fluorescent end product becomes visible/can be detected using an ultraviolet (UV) lamp.
3.2 Terminology of performance testing
3.2.1
performance of culture medium
response of a culture medium to challenge by test organisms under defined conditions
3.2.2
target microorganism
microorganism or group of microorganisms to be detected or enumerated
3.2.3
non-target microorganism
microorganism that is suppressed by the medium and/or conditions of incubation or does not show
expected characteristics of the target microorganism
3.2.4
productivity of culture medium
level of recovery of a target microorganism from the culture medium under defined conditions
3.2.5
selectivity of culture medium
degree of inhibition of a non-target microorganism on or in a selective culture medium under defined
conditions
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SIST EN ISO 11133:2014
ISO 11133:2014(E)
3.2.6
electivity of culture medium
specificity of culture medium
demonstration, under defined conditions, that non-target microorganisms do not show the same visual
characteristics as target microorganisms
3.3 Terminology of culture media
3.3.1
culture medium
formulation of substances, in liquid, semi-solid or solid form, which contain natural and/or
synthetic constituents intended to support the multiplication, (with or without inhibition of certain
microorganisms), identification or preservation of viability of microorganisms
Note 1 to entry: When used in connection with compound words, this term is often shortened to read “medium”
(e.g. enrichment medium).
3.3.2 Culture media classified by composition
3.3.2.1
chemically defined medium
culture medium consisting only of chemically defined constituents of known molecular structure and
degree of purity
3.3.2.2
chemically undefined or partially undefined medium
culture medium consisting entirely or partly of natural materials, processed or otherwise, the chemical
composition of which is not completely defined
Note 1 to entry: Harmonized designations for various chemically undefined components used in culture media
are specified in Annex A.
3.3.2.3
chromogenic culture medium
fluorogenic culture medium
culture medium containing one or more chromogenic/fluorogenic substrates
Note 1 to entry: Chromogenic culture media facilitate the identification of bacteria or fungi by means of
defined colour and morphological characteristics (culture medium typical growth). Fluorogenic media require
visualization using a UV lamp. The biochemical reaction products, which are necessary for the efficiency of
chromogenic/fluorogenic culture media, are normally the result of the enzymatic activity of certain organisms,
which in turn depends greatly on the precise maintenance of specific conditions (e.g. temperature, pH value,
concentrations of substrate).
3.3.3 Culture media classified by physical consistency
3.3.3.1
liquid medium
culture medium consisting of an aqueous solution of one or more constituents, such as peptone water
and nutrient broth
Note 1 to entry: In some cases,
...
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