EN ISO 21148:2009
(Main)Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005)
Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005)
ISO 21148:2005 gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).
Kosmetik - Mikrobiologie - Allgemeine Anleitungen zur mikrobiologischen Untersuchung (ISO 21148:2005)
Diese Internationale Norm gibt allgemeine Anleitungen für die Durchführung von mikrobiologischen Unter-suchungen kosmetischer Mittel, damit deren Qualität und Sicherheit in Übereinstimmung mit einer entsprechenden Risikoanalyse [z. B. geringe Wasseraktivität (niedriger aw-Wert), hydroalkoholischer Anteil, extreme pH-Werte] sichergestellt ist.
Wegen der großen Vielfalt an kosmetischen Mitteln und potentiellen Anwendungsmöglichkeiten innerhalb dieses Anwendungsbereichs sind diese Anleitungen möglicherweise für einige Produkte nicht in allen Einzelheiten geeignet (z. B. bestimmte mit Wasser nicht mischbare Produkte).
Cosmétiques - Microbiologie - Instructions générales pour les examens microbiologiques (ISO 21148:2005, Cor 1:2006 inclus)
L'ISO 21148:2005 donne des règles générales pour la réalisation d'examens microbiologiques sur des produits cosmétiques afin de garantir leur qualité et leur innocuité, conformément à une analyse de risque appropriée (par exemple faible activité de l'eau, produit hydro-alcoolique, valeurs de pH extrêmes).
En raison de la grande variété de produits entrant dans le champ d'application de la présente norme et de leurs usages potentiels, ces règles peuvent ne pas être adaptées en tout point à certains produits (par exemple produits non miscibles à l'eau).
Kozmetika - Mikrobiologija - Splošna navodila za mikrobiološko preskušanje (ISO 21148:2005, vključno s popravkom Cor 1:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2009
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Cosmetics - Microbiology - General instructions for microbiological examination (ISO
21148:2005, including Cor 1:2006)
Kosmetik - Mikrobiologie - Allgemeine Anleitungen für mikrobiologische Untersuchungen
(ISO 21148:2005 mit Cor 1:2006)
Cosmétiques - Microbiologie - Instructions générales pour les examens microbiologiques
(ISO 21148:2005, Cor 1:2006 inclus)
Ta slovenski standard je istoveten z: EN ISO 21148:2009
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 21148
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - General instructions for
microbiological examination (ISO 21148:2005)
Cosmétiques - Microbiologie - Instructions générales pour Kosmetik - Mikrobiologie - Allgemeine Anleitungen für
les examens microbiologiques (ISO 21148:2005, Cor mikrobiologische Untersuchungen (ISO 21148:2005)
1:2006 inclus)
This European Standard was approved by CEN on 23 May 2009.
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 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 Management Centre has the same status as the
official versions.
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. EN ISO 21148:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
The text of ISO 21148:2005 has been prepared by Technical Committee ISO/TC 217 “Cosmetics” of the
International Organization for Standardization (ISO) and has been taken over as EN ISO 21148:2009 by
Technical Committee CEN/SS H99 “Products for household and leisure use - Undetermined” the secretariat of
which is held by CMC.
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 December 2009, and conflicting national standards shall be withdrawn
at the latest by December 2009.
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, 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.
Endorsement notice
The text of ISO 21148:2005 has been approved by CEN as a EN ISO 21148:2009 without any modification.
INTERNATIONAL ISO
STANDARD 21148
First edition
2005-10-15
Cosmetics — Microbiology — General
instructions for microbiological
examination
Cosmétiques — Microbiologie — Instructions générales pour les
examens microbiologiques
Reference number
ISO 21148:2005(E)
©
ISO 2005
ISO 21148:2005(E)
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ii © ISO 2005 – All rights reserved
ISO 21148:2005(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope .1
2 Terms and definitions .1
3 Premises .1
4 Equipment .3
5 Strains of microorganisms .6
6 Personnel.6
7 Preparation of the apparatus and glassware.6
8 Preparation and sterilization of culture media and reagents.8
9 Laboratory samples.10
10 Operating practices .12
11 Expression of results .13
12 Neutralization of the antimicrobial properties of the product.13
Annex A (informative) Basic identification techniques.14
Annex B (informative) Basic techniques for counting and plating .19
Annex C (informative) Preparation and calibration of inoculums.20
ISO 21148:2005(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.
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 21148 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2005 – All rights reserved
ISO 21148:2005(E)
Introduction
The purpose of this International Standard is to help ensure that the general techniques used for conducting
cosmetic microbiological examinations are the same in other laboratories that adopt these standards, to help
achieve homogeneous results in different laboratories and to contribute towards the protection of the health of
the laboratory personnel by preventing risk of infection.
When conducting microbiological examinations for cosmetic products, it is especially important that:
⎯ only those microorganisms which are present in the samples be isolated or enumerated;
⎯ the microorganisms do not contaminate the environment.
In order to achieve this, it is necessary to pay attention to personal hygiene and to use working techniques
which ensure, as far as possible, exclusion of extraneous contamination.
Since, in this International Standard it is possible to give only a few examples of the precautions to be taken
during microbiological examinations, a thorough knowledge of the microbiological techniques and of the
microorganisms involved is essential. It is important that the analyses be conducted as accurately as possible,
including calculation of the number of microorganisms.
A large number of manipulations can, for example, unintentionally lead to cross-contamination and the analyst
should always verify the accuracy of the results given by his/her technique. It is necessary to take special
precautions, not only for reasons of hygiene, but also to ensure good reproducibility of the results. It is not
possible to specify all the precautions to be taken in all circumstances, but this International Standard at least
provides the main measures to be taken when preparing, sterilizing and storing the media and the equipment.
The given recommendations will allow enumeration and detection of mesophilic microorganisms which may
grow under aerobic conditions.
The recommendations are applicable to the determination of the absence of, or limited occurrence of specified
microorganisms that are of interest for cosmetic products.
The test methods are described in the individual standards. Alternative microbiological procedures can be
used provided that their equivalence has been demonstrated or the method has been otherwise validated.
The choice of a specific method, or combination of methods mentioned in these International Standards will
depend on the purpose for performing the test and it is for the user to decide which approach is best for
his/her application.
INTERNATIONAL STANDARD ISO 21148:2005(E)
Cosmetics — Microbiology — General instructions for
microbiological examination
1 Scope
This International Standard gives general instructions for carrying out microbiological examinations of
cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis
(e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions
might not be appropriate for some products in every detail (e.g. certain water-immiscible products).
2 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
2.1
product
portion of an identified cosmetic product received in the laboratory for testing
2.2
sample
portion of the product (at least 1 g or 1 ml) which is used in the test to prepare the initial suspension
2.3
initial suspension
suspension (or solution) of a sample in a defined volume of an appropriate liquid (diluent, neutralizer, broth or
combination of them)
2.4
sample dilution
dilution of the initial suspension
3 Premises
3.1 Test areas
The areas required for the specific operation of a microbiology laboratory are as follows:
⎯ receipt, storage, preparation and processing of the samples;
⎯ preparation an
...
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