EN ISO 21149:2009
(Main)Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2006)
Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2006)
ISO 21149:2006 gives general guidelines for enumeration and detection of mesophilic aerobic bacteria present in cosmetics:
by counting the colonies on agar medium after aerobic incubation, or
by checking the absence of bacterial growth after enrichment.
Because of the large variety of cosmetic products within this field of application, this method may not be appropriate for some products in every detail (e.g. certain water immiscible products). Other methods (e.g. automated) may be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise validated.
If needed, microorganisms enumerated or detected may be identified using suitable identification tests described in the standards given in the Bibliography.
Kosmetik - Mikrobiologie - Zählung und Nachweis von aeroben mesophilen Bakterien (ISO 21149:2006)
Diese Internationale Norm gibt allgemeine Anleitungen für die Zählung und zum Nachweis von in Kosmetika
vorhandenen mesophilen aeroben Bakterien,
- durch Zählen der Kolonien auf einem Agarmedium nach aerober Bebrütung oder
- durch Überprüfen des Ausbleibens von bakteriellem Wachstum nach Anreicherung.
Wegen der großen Vielfalt an kosmetischen Mitteln innerhalb dieses Anwendungsbereiches braucht dieses
Verfahren nicht zwangsläufig bis in alle Einzelheiten auf bestimmte Mittel anwendbar zu sein (z. B. bestimmte
mit Wasser nicht mischbare Produkte). Ersatzweise können für die hier aufgeführten Untersuchungen andere
Verfahren (z. B. automatisierte) zur Anwendung kommen, vorausgesetzt, dass deren Gleichwertigkeit nachgewiesen
oder das Verfahren anderweitig validiert wurde.
Falls es erforderlich sein sollte, können ausgezählte oder nachgewiesene Mikroorganismen mit geeigneten
Identifizierungsprüfungen bestimmt werden, die in den unter den Literaturhinweisen aufgeführten Normen
beschrieben sind.
Um die Qualität des Produkts und die Sicherheit für Verbraucher sicherzustellen, ist es ratsam, eine geeignete
mikrobiologische Risikoanalyse zur Bestimmung der Arten von kosmetischen Mitteln durchzuführen, für die
diese Internationale Norm anwendbar ist. Produkte, die ein geringes mikrobiologisches Risiko darstellen, umfassen
Produkte mit geringer Wasseraktivität, alkoholisch-wässrige Produkte, Produkte mit extremen pH-Werten
usw.
Cosmétiques - Microbiologie - Dénombrement et détection des bactéries aérobies mésophiles (ISO 21149:2006)
L'ISO 21149:2006 donne des lignes directrices générales pour le dénombrement et la détection des bactéries aérobies mésophiles présentes dans les cosmétiques:
par dénombrement des colonies en milieu gélosé après une incubation aérobie, ou
en vérifiant l'absence de croissance bactérienne après enrichissement.
En raison de la grande variété de produits cosmétiques entrant dans ce domaine d'application, la présente méthode peut ne pas être, en tout point, adaptée à certains produits (par exemple à certains produits non miscibles dans l'eau). Il est possible de remplacer les essais présentés ici par d'autres méthodes (automatisées, par exemple), sous réserve que leur équivalence ait été démontrée ou que la méthode ait été validée par ailleurs.
Au besoin, les micro-organismes dénombrés ou détectés peuvent être identifiés à l'aide d'essais d'identification appropriés décrits dans les normes indiquées dans la Bibliographie.
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti in števila aerobnih mezofilnih bakterij (ISO 21149:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2009
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti in števila aerobnih mezofilnih
bakterij (ISO 21149:2006)
Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria
(ISO 21149:2006)
Kosmetik - Mikrobiologie - Zählung und Nachweis von aeroben mesophilen Bakterien
(ISO 21149:2006)
Cosmétiques - Microbiologie - Dénombrement et détection des bactéries aérobies
mésophiles (ISO 21149:2006)
Ta slovenski standard je istoveten z: EN ISO 21149:2009
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 21149
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - Enumeration and detection of
aerobic mesophilic bacteria (ISO 21149:2006)
Cosmétiques - Microbiologie - Dénombrement et détection Kosmetik - Mikrobiologie - Zählung und Nachweis von
des bactéries aérobies mésophiles (ISO 21149:2006) aeroben mesophilen Bakterien (ISO 21149:2006)
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 21149:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
The text of ISO 21149:2006 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 21149:2009 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 21149:2006 has been approved by CEN as a EN ISO 21149:2009 without any modification.
INTERNATIONAL ISO
STANDARD 21149
First edition
2006-03-01
Cosmetics — Microbiology —
Enumeration and detection of aerobic
mesophilic bacteria
Cosmétiques — Microbiologie — Dénombrement et détection des
bactéries aérobies mésophiles
Reference number
ISO 21149:2006(E)
©
ISO 2006
ISO 21149:2006(E)
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ii © ISO 2006 – All rights reserved
ISO 21149:2006(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Principle. 2
4.1 General. 2
4.2 Plate count. 2
4.3 Membrane filtration. 2
4.4 Detection of bacteria by enrichment. 3
5 Diluents, neutralizers and culture media. 3
5.1 General. 3
5.2 Neutralizing diluents and diluents . 3
5.3 Diluent for the bacterial suspension (tryptone sodium chloride solution). 4
5.4 Culture media . 4
6 Apparatus and glassware. 6
7 Strains of microorganisms . 7
8 Handling of cosmetic products and laboratory samples . 7
9 Procedure. 7
9.1 General recommendation . 7
9.2 Preparation of the initial suspension. 7
9.3 Counting methods . 8
9.4 Enrichment. 9
10 Counting of colonies (plate counts and membrane filtration methods). 9
11 Detection of growth (enrichment method) . 9
12 Expression of results. 10
12.1 Method of calculation for plate count. 10
12.2 Interpretation. 10
12.3 Examples. 11
12.4 Detection after enrichment . 13
13 Neutralization of the antimicrobial properties of the product. 13
13.1 General. 13
13.2 Preparation of inoculum . 14
13.3 Validation of counting methods. 14
13.4 Validation of the detection method by enrichment . 15
13.5 Interpretation of validation results. 15
14 Test report. 16
Annex A (informative) Other neutralizing diluents . 17
Annex B (informative) Other diluents. 19
Annex C (informative) Other culture media . 20
Annex D (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 23
Bibliography . 24
ISO 21149:2006(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 21149 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2006 – All rights reserved
INTERNATIONAL STANDARD ISO 21149:2006(E)
Cosmetics — Microbiology — Enumeration and detection
of aerobic mesophilic bacteria
1 Scope
This International Standard gives general guidelines for enumeration and detection of mesophilic aerobic
bacteria present in cosmetics,
⎯ by counting the colonies on agar medium after aerobic incubation, or
⎯ by checking the absence of bacterial growth after enrichment.
Because of the large variety of cosmetic products within this field of application, this method may not be
appropriate for some products in every detail (e.g. certain water immiscible products). Other methods
(e.g. automated) may be substituted for the tests presented here provided that their equivalence has be
...
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