SIST-TS CEN ISO/TS 11133-1:2009
(Main)Microbiology of food and animal feeding stuffs - Guidelines on preparation and production of culture media - Part 1: General guidelines on quality assurance for the preparation of culture media in the laboratory (ISO/TS 11133-1:2009)
Microbiology of food and animal feeding stuffs - Guidelines on preparation and production of culture media - Part 1: General guidelines on quality assurance for the preparation of culture media in the laboratory (ISO/TS 11133-1:2009)
This part of ISO/TS 11133 provides the general terminology related to quality assurance and specifies the minimum requirements for the preparation of culture media to be used for the microbiological analysis of products intended for human consumption or animal feeding. It is also applicable to culture media to be used for the microbiological analysis of all kinds of water. These requirements are applicable to four categories of culture media used in laboratories that prepare and/or use culture media for performing microbiological analyses:
- commercially manufactured ready-to-use media;
- media to be remelted, supplemented and distributed;
- media prepared from commercially available dehydrated formulations;
- media prepared from their individual components.
Mikrobiologie von Lebensmitteln und Futtermitteln - Anleitungen für die Zubereitung und Herstellung von Nährmedien - Teil 1: Allgemeine Anleitungen für die Qualitätssicherung bei der Zubereitung von Nährmedien im Laboratorium (ISO/TS 11133-1:2009)
Dieser Teil von ISO/TS 11133 enthält die allgemeine Terminologie hinsichtlich der Qualitätssicherung und legt die Mindestanforderungen an die Zubereitung von Nährmedien fest, die für mikrobiologische Unter¬suchungen von Produkten verwendet werden sollen, die für den menschlichen Verzehr oder als Futtermittel vorgesehen sind.
Er ist auch auf die Nährmedien anwendbar, die für mikrobiologische Untersuchungen aller Arten von Wasser verwendet werden.
Diese Anforderungen gelten für folgende vier Arten von in Laboratorien verwendeten Nährmedien; wobei das Laboratorium für die mikrobiologischen Untersuchungen Nährmedien herstellt und/oder verwendet:
handelsübliche Fertigmedien;
Medien, die wiederaufzuschmelzen, zu supplementieren und zu verteilen sind;
aus handelsüblichen Trockenmedien hergestellte Medien;
aus einzelnen Grundsubstanzen hergestellte Medien.
Microbiologie des aliments - Lignes directrices pour la préparation et la production des milieux de culture - Partie 1: Lignes directrices générales d'assurance qualité pour la préparation des milieux de culture en laboratoire (ISO/TS 11133-1:2009)
L'ISO/TS 11133-1:2009 fournit la terminologie générale relative à l'assurance qualité et spécifie les exigences minimales relatives à la préparation des milieux de culture à appliquer pour l'analyse microbiologique de produits destinés à la consommation humaine ou à l'alimentation des animaux.
Elle est également applicable aux milieux de culture à utiliser pour l'analyse microbiologique de tous les types d'eau.
Ces exigences sont applicables à quatre catégories de milieux de culture utilisés dans les laboratoires qui les préparent et/ou les utilisent pour réaliser des analyses microbiologiques: les milieux commerciaux prêts à l'emploi, les milieux à régénérer, supplémenter et répartir, les milieux préparés à partir de formules déshydratées commerciales et les milieux préparés à partir de leurs composants individuels.
Mikrobiologija živil in krme - Navodila za pripravo in izdelavo gojišča - 1. del: Splošna navodila o zagotavljanju kakovosti priprave gojišča v laboratoriju (ISO/TS 11133-1:2009)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 11133-1:2009
01-maj-2009
1DGRPHãþD
SIST ENV ISO 11133-1:2002
0LNURELRORJLMDåLYLOLQNUPH1DYRGLOD]DSULSUDYRLQL]GHODYRJRMLãþDGHO
6SORãQDQDYRGLODR]DJRWDYOMDQMXNDNRYRVWLSULSUDYHJRMLãþDYODERUDWRULMX ,6276
Microbiology of food and animal feeding stuffs - Guidelines on preparation and
production of culture media - Part 1: General guidelines on quality assurance for the
preparation of culture media in the laboratory (ISO/TS 11133-1:2009)
Mikrobiologie von Lebensmitteln und Futtermitteln - Anleitungen für die Zubereitung und
Herstellung von Nährmedien - Teil 1: Allgemeine Anleitungen für die Qualitätssicherung
bei der Zubereitung von Nährmedien im Laboratorium (ISO/TS 11133-1:2009)
Microbiologie des aliments - Lignes directrices pour la préparation et la production des
milieux de culture - Partie 1: Lignes directrices générales d'assurance qualité pour la
préparation des milieux de culture en laboratoire (ISO/TS 11133-1:2009)
Ta slovenski standard je istoveten z: CEN ISO/TS 11133-1:2009
ICS:
07.100.30 Mikrobiologija živil Food microbiology
SIST-TS CEN ISO/TS 11133-1:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST-TS CEN ISO/TS 11133-1:2009
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SIST-TS CEN ISO/TS 11133-1:2009
TECHNICAL SPECIFICATION
CEN ISO/TS 11133-1
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
February 2009
ICS 07.100.30 Supersedes ENV ISO 11133-1:2000
English Version
Microbiology of food and animal feeding stuffs - Guidelines on
preparation and production of culture media - Part 1: General
guidelines on quality assurance for the preparation of culture
media in the laboratory (ISO/TS 11133-1:2009)
Microbiologie des aliments - Lignes directrices pour la Mikrobiologie von Lebensmitteln und Futtermitteln -
préparation et la production des milieux de culture - Partie Anleitungen für die Zubereitung und Herstellung von
1: Lignes directrices générales d'assurance qualité pour la Nährmedien - Teil 1: Allgemeine Anleitungen für die
préparation des milieux de culture en laboratoire (ISO/TS Qualitätssicherung bei der Zubereitung von Nährmedien im
11133-1:2009) Laboratorium (ISO/TS 11133-1:2008)
This Technical Specification (CEN/TS) was approved by CEN on 23 June 2008 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to submit their
comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS available
promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in parallel to the CEN/TS)
until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 11133-1:2009: E
worldwide for CEN national Members.
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SIST-TS CEN ISO/TS 11133-1:2009
CEN ISO/TS 11133-1:2009 (E)
Contents Page
Foreword .3
2
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SIST-TS CEN ISO/TS 11133-1:2009
CEN ISO/TS 11133-1:2009 (E)
Foreword
This document (CEN ISO/TS 11133-1:2009) has been prepared by Technical Committee CEN/TC 275 “Food
analysis - Horizontal methods", the secretariat of which is held by DIN, in collaboration with Technical
Committee ISO/TC 34 "Agricultural food products".
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 ENV ISO 11133-1:2000.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
3
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SIST-TS CEN ISO/TS 11133-1:2009
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SIST-TS CEN ISO/TS 11133-1:2009
TECHNICAL ISO/TS
SPECIFICATION 11133-1
Second edition
2009-02-01
Microbiology of food and animal feeding
stuffs — Guidelines on preparation and
production of culture media —
Part 1:
General guidelines on quality assurance
for the preparation of culture media in the
laboratory
Microbiologie des aliments — Lignes directrices pour la préparation et
la production des milieux de culture —
Partie 1: Lignes directrices générales d'assurance qualité pour la
préparation des milieux de culture en laboratoire
Reference number
ISO/TS 11133-1:2009(E)
©
ISO 2009
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SIST-TS CEN ISO/TS 11133-1:2009
ISO/TS 11133-1:2009(E)
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ii © ISO 2009 – All rights reserved
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SIST-TS CEN ISO/TS 11133-1:2009
ISO/TS 11133-1:2009(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
3.1 General. 1
3.2 Culture media . 2
3.3 Test microorganisms. 5
4 Quality assurance of culture media. 5
4.1 Documentation. 5
4.2 Storage. 6
4.3 Laboratory preparation of media . 7
4.4 Preparation for use. 9
4.5 Disposal of media . 10
5 Preservation and maintenance of control strains . 10
5.1 General. 10
5.2 Control strains from commercial sources . 10
5.3 Laboratory-prepared reference stocks. 10
5.4 Stock cultures . 10
5.5 Working cultures. 11
6 Performance testing of finished culture media . 11
6.1 General. 11
6.2 Physical quality control . 11
6.3 Microbiological quality control. 11
Annex A (informative) Designation of the components of the culture media in standards on
microbiological analysis of food and animal feeding stuffs . 13
Annex B (informative) Preparation of reference stock and working culture. 15
Annex C (informative) Quality assurance of culture media — Troubleshooting. 17
Bibliography . 18
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SIST-TS CEN ISO/TS 11133-1:2009
ISO/TS 11133-1:2009(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
In other circumstances, particularly when there is an urgent market requirement for such documents, a
technical committee may decide to publish other types of document:
⎯ an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in
an ISO working group and is accepted for publication if it is approved by more than 50 % of the members
of the parent committee casting a vote;
⎯ an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical
committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting
a vote.
An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a
further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is
confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an
International Standard or be withdrawn.
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.
ISO/TS 11133-1 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 275, Food analysis — Horizontal methods, in collaboration with Technical Committee ISO/TC 34,
Food products, Subcommittee SC 9, Microbiology, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO/TS 11133-1:2000), which has been technically
revised.
ISO/TS 11133 consists of the following parts, under the general title Microbiology of food and animal feeding
stuffs — Guidelines on preparation and production of culture media:
⎯ Part 1: General guidelines on quality assurance for the preparation of culture media in the laboratory
⎯ Part 2: Practical guidelines on performance testing of culture media
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ISO/TS 11133-1:2009(E)
Introduction
Culture media are used in all traditional culture techniques and also for many alternative techniques. In the
microbiology laboratory, many tests and procedures depend upon culture media being consistent and
providing reproducible results. Many formulations of dehydrated culture media are commercially available and
many more, designed for specific growth purposes, are described in the literature. In laboratories carrying out
microbiological examinations of foods and feedstuffs, the main objectives are to maintain, resuscitate, grow,
detect and/or enumerate a wide variety of microorganisms. The requirements for media are specific to both
the sample and the organisms to be detected. Culture media meeting established or minimal performance
criteria are therefore a prerequisite for any reliable microbiological work. Sufficient testing should be carried
out to demonstrate: i) the acceptability of each batch of medium; ii) that the medium is “fit for purpose”; and iii)
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 precise data.
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SIST-TS CEN ISO/TS 11133-1:2009
TECHNICAL SPECIFICATION ISO/TS 11133-1:2009(E)
Microbiology of food and animal feeding stuffs — Guidelines on
preparation and production of culture media —
Part 1:
General guidelines on quality assurance for the preparation of
culture media in the laboratory
1 Scope
This part of ISO/TS 11133 provides the general terminology related to quality assurance and specifies the
minimum requirements for the preparation of culture media to be used for the microbiological analysis of
products intended for human consumption or animal feeding.
It is also applicable to culture media to be used for the microbiological analysis of all kinds of water.
These requirements are applicable to four categories of culture media used in laboratories that prepare and/or
use culture media for performing microbiological analyses:
⎯ commercially manufactured ready-to-use media;
⎯ media to be remelted, supplemented and distributed;
⎯ media prepared from commercially available dehydrated formulations;
⎯ media prepared from their individual components.
2 Normative references
The following referenced documents are indispensable for the application 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 7218, Microbiology of food and animal feeding stuffs — General requirements and guidance for
microbiological examinations
ISO 11133-2:2003, Microbiology of food and animal feeding stuffs — Guidelines on preparation and
production of culture media — Part 2: Practical guidelines on performance testing of culture media
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 General
3.1.1
quality control
〈food and feedstuffs〉 technical operations and activities that are used to fulfil the requirements for quality
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ISO/TS 11133-1:2009(E)
3.1.2
batch of culture media
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 passed the requirements of
production (in-process control) and performance testing, and which has been produced within one defined
production period, having been assigned the same number
3.1.3
performance of culture media
response of a culture medium to challenge by test organisms under defined conditions
3.2 Culture media
3.2.1
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 When used in connection with compound words, this term is often shortened to “medium” (e.g. enrichment
medium).
3.2.2
chemically defined medium
culture medium consisting only of chemical constituents of known molecular structure and degree of purity
3.2.3
chemically undefined medium
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 Harmonized designations for various chemically undefined components used in culture media are specified in
Annex A.
3.2.4
liquid medium
culture medium consisting of an aqueous solution of one or more constituents
EXAMPLES Peptone water, nutrient broth.
NOTE 1 In some cases, solid particles are added to the liquid culture medium.
NOTE 2 A liquid medium in tubes, flasks or bottles is commonly called “broth”.
3.2.5
solid medium
semi-solid medium
liquid medium containing solidifying substances (e.g. agar-agar, gelatin) in different concentrations
NOTE 1 Due to the worldwide use of media solidified with agar-agar, the shortened term “agar” is often used
synonymously for solid media and therefore in connection with nouns, e.g. “plate count agar”.
NOTE 2 Solid media poured into Petri dishes are commonly called “plates”. Solid media poured into tubes or small
bottles that are kept in slanted positions while the media are solidifying are often called “slants” or “slopes”.
3.2.6
transport medium
medium designed to preserve and maintain the viability of microorganisms without permitting significant
multiplication in the time period between sample collection and laboratory processing of the sample
NOTE Transport media usually contain substances that do not permit multiplication of microorganisms but ensure
their maintenance, e.g. Stuart's or Amies's transport medium.
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3.2.7
preservation medium
medium designed to maintain the viability of microorganisms over an extended period, to protect them against
the adverse influences which may occur during long-term storage and to allow recovery after this period
EXAMPLES Dorset egg medium, nutrient agar slopes.
3.2.8
suspension medium
medium designed to separate microorganisms from a test product into a liquid phase without multiplication or
inhibition during the time of contact
EXAMPLE Peptone saline solution.
NOTE 1 Suspension media are also used for dilution purposes.
NOTE 2 Suspension medium is commonly called “diluent”.
3.2.9
resuscitation medium
medium enabling stressed and damaged microorganisms to repair and recover their capacity for normal
growth without necessarily promoting their multiplication
EXAMPLE Buffered peptone water.
NOTE This may also be used as a pre-enrichment medium.
3.2.10
pre-enrichment medium
enrichment medium
generally liquid medium which, due to its composition, provides particularly favourable conditions for
multiplication of microorganisms
3.2.11
selective enrichment medium
enrichment medium which allows the multiplication of specific microorganisms whilst partially or totally
inhibiting the growth of other microorganisms
EXAMPLE Rappaport-Vassiliadis soya medium.
3.2.12
non-selective enrichment medium
enrichment medium which allows the growth of a wide variety of microorganisms
EXAMPLE Nutrient broth.
3.2.13
isolation medium
solid or semi-solid medium which allows the growth of microorganisms
EXAMPLE Plate count agar.
3.2.14
selective isolation medium
isolation medium which allows growth of specific target microorganisms, while inhibiting other microorganisms
EXAMPLE XLD agar.
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ISO/TS 11133-1:2009(E)
3.2.15
non-selective isolation medium
isolation medium which is not intended to selectively inhibit microorganisms
EXAMPLE Plate count agar.
3.2.16
differential medium
characterization medium
medium which permits the testing of one or more physiological/biochemical characteristics of the
microorganisms for their identification
EXAMPLE MacConkey agar.
NOTE Differential media which can be used as isolation media are referred to as isolation/differential media, e.g.
XLD agar, lactose TTC agar.
3.2.17
identification medium
medium designed to produce a specific identification reaction which usually does not require any further
confirmatory test
EXAMPLE Bile esculin agar, TBX agar.
NOTE Identification media which can be used as isolation media are referred to as isolation/identification media.
3.2.18
enumeration medium
selective or non-selective culture medium which enables a quantification of the microorganisms
NOTE An enumeration medium can include the properties of a resuscitation and/or enrichment medium.
3.2.19
confirmation medium
medium which contributes partly or wholly to the identification or to the characterization of the microorganisms
following a preliminary resuscitation, isolation and/or enrichment stage
EXAMPLE Kligler agar.
3.2.20
medium having multiple uses
medium assigned to several categories
EXAMPLE Blood agar is a resuscitation medium according to 3.2.9, an isolation medium according to 3.2.13 and a
differential medium according to 3.2.16 used for detection of haemolysis.
3.2.21
ready-to-use medium
liquid, solid or semi-solid medium which is supplied in containers in ready-to-use form or ready-to-use after
remelting
EXAMPLES Plates, tubes or other containers:
⎯ complete ready-to-use medium;
⎯ medium to be remelted, e.g. for use in pour-plate technique;
⎯ medium to be remelted and dispensed before use, e.g. to be poured into Petri dishes;
⎯ medium to be remelted, supplemented and dispensed before use, e.g. TSC medium, Baird Parker RPF agar.
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3.2.22
medium prepared from commercially dehydrated formulations
medium in dry form which requires rehydration and processing prior to use
EXAMPLES Powders, granules, lyophilized products, resulting in one of two kinds of media:
⎯ a complete medium;
⎯ an incomplete medium to which supplements are added before use.
3.2.23
medium prepared from individual components
medium entirely produced from the complete formula of its specific ingredients
3.3 Test microorganisms
3.3.1
test organisms
microorganisms generally used for performance testing of culture media
NOTE Test organisms are further defined according to their source (see 3.3.2 to 3.3.5).
3.3.2
reference strain
microorganism obtained directly from an official culture collection and defined to at least the genus and
species level, catalogued and described according to its characteristics and preferably originating from food or
water as applicable
3.3.3
reference stock
a set of separate identical cultures obtained in the laboratory by a single subculture from the reference strain
obtained either in the laboratory or from a supplier
3.3.4
stock culture
primary subculture from a reference stock
3.3.5
working culture
subculture from a reference stock or stock culture or a reference material, certified or not
NOTE Reference material is a material containing a quantity of revivable microorganisms in a homogeneous, stable
concentration. A certified reference material is a reference material for which the concentration is certified.
4 Quality assurance of culture media
4.1 Documentation
4.1.1 Documentation from manufacturer or producer
The following details should be available from the manufacturer or producer:
⎯ name of the medium, individual components and any supplements and their product codes;
⎯ batch number;
⎯ target pH of the complete medium;
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ISO/TS 11133-1:2009(E)
⎯ storage information and expiry date;
⎯ quality control certificate and test organisms used;
⎯ results of performance testing with criteria of acceptance;
⎯ technical data sheet;
⎯ safety and/or hazard data where needed.
4.1.2 Delivery acceptance of products
For each batch of product (ingredient or culture medium), check the following:
⎯ identification of the product;
⎯ integrity of packaging;
⎯ expiry date of the product;
⎯ documentation supplied.
Record the date of receipt.
4.2 Storage
4.2.1 General
In all cases, follow the manufacturer’s instructions regarding storage conditions, expiry date and use.
4.2.2 Quality management and control for dehydrated media and supplements
Media are delivered as dehydrated powders or in granulated form in sealed containers. Supplements of
different selective or diagnostic substances are supplied in either the lyophilized or liquid state. Purchases
should be planned to encourage a regular turnover of stock (i.e. first in-first out). To maintain an inventory:
⎯ check the seal;
⎯ record date of first opening;
⎯ assess visually the contents of opened containers.
Especially after opening a new container, the quality of the medium may depend on the storage environment.
Loss of quality of dehydrated media is shown by change in flow characteristics of the powder, homogeneity,
caking, colour changes, etc. Any dehydrated medium that has absorbed moisture or shows obvious changes
in physical appearance shall be discarded.
4.2.3 Commercially supplied ready-to-use media
Follow the manufacturer’s instructions regarding storage conditions, expiry date and use.
4.2.4 Laboratory prepared media
The shelf-life of media varies. Specific International Standards or national standards may stipulate specific
conditions and shelf-life.
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ISO/TS 11133-1:2009(E)
Store the media under conditions which prevent any modification of their composition, namely protected from
light and des
...
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