EN ISO 18416:2009
(Main)Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2007)
Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2007)
ISO 18416:2007 gives general guidelines for the detection and identification of the specified microorganism Candida albicans in cosmetic products. Microorganisms considered as specified in this International Standard might differ from country to country according to national practices or regulations.
The method described in ISO 18416:2007 is based on the detection of Candida albicans in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate dependent on the level of detection required.
Because of the large variety of cosmetic products within this field of application, this method might not be suited in every detail, to some products (e.g. certain water-immiscible products). Other International Standards (e.g. ISO 18415) might be appropriate. Other methods (e.g. automated) can be substituted for the test presented here provided that their equivalence has been demonstrated or the method has been otherwise validated.
Kosmetik - Mikrobiologie - Nachweis von Candida albicans (ISO 18416:2007)
Diese Internationale Norm gibt allgemeine Anleitungen für den Nachweis und die Identifizierung des beschrie¬benen Mikroorganismus Candida albicans in kosmetischen Mitteln. Die in dieser Internationalen Norm vorge¬gebenen Mikroorganismen können in Übereinstimmung mit nationalen Praktiken oder Regelungen von Land zu Land unterschiedlich sein.
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.
Das in dieser Internationalen Norm beschriebene Verfahren basiert auf dem Nachweis von Candida albicans in einem nicht selektiven Flüssigmedium (Anreicherungsbouillon), gefolgt von einer Isolation auf einem selek¬tiven Agarmedium. In Abhängigkeit von der erforderlichen Nachweisgrenze können andere Verfahren ange¬messen sein.
ANMERKUNG Für den Nachweis von Candida albicans kann eine Subkultivierung auf nicht selektiven Nährmedien erfolgen, gefolgt von geeigneten Schritten zur Identifizierung (z. B. unter Anwendung von Identifizierungskits).
Wegen der großen Vielfalt an kosmetischen Mitteln innerhalb dieses Anwendungsbereichs ist dieses Verfahren möglicherweise für einige Produkte nicht in allen Einzelheiten geeignet (z. B. bestimmte mit Wasser nicht mischbare Produkte). Andere Internationale Normen (z. B. ISO 18415) könnten geeignet sein. Ersatzweise können für die hier aufgeführten Untersuchungen andere Verfahren (z. B. automatisierte) zur Anwendung kommen, vorausgesetzt, dass deren Gleichwertigkeit nach¬gewiesen oder das Verfahren anderweitig validiert wurde.
Cosmétiques - Microbiologie - Détection de Candida albicans (ISO 18416:2007)
L'ISO 18416:2007 donne des lignes directrices générales pour la détection et l'identification du microorganisme spécifié Candida albicans dans les produits cosmétiques. Les microorganismes considérés comme spécifiés dans l'ISO 18416:2007 peuvent différer d'un pays à l'autre, suivant les pratiques ou les réglementations nationales.
La méthode décrite dans l'ISO 18416:2007 repose d'abord sur la détection de Candida albicans dans un milieu liquide non sélectif (milieu liquide d'enrichissement), puis sur l'isolement dudit microorganisme sur un milieu gélosé sélectif. D'autres méthodes peuvent être appropriées en fonction du niveau de détection exigé.
En raison de la grande variété de produits cosmétiques relevant de ce domaine d'application, il se peut que cette méthode ne soit pas adaptée en tous points, à certains produits (par exemple aux produits non miscibles à l'eau). Une autre Norme internationale peut être appropriée. Il est possible de remplacer l'essai présenté ici par d'autres méthodes (par exemple des méthodes automatisées) sous réserve que leur équivalence a été démontrée ou que la méthode a été validée par ailleurs.
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti kvasovke Candida albicans (ISO 18416:2007)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2009
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti kvasovke Candida albicans
(ISO 18416:2007)
Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2007)
Kosmetik - Mikrobiologie - Nachweis von Candida albicans (ISO 18416:2007)
Cosmétiques - Microbiologie - Détection de Candida albicans (ISO 18416:2007)
Ta slovenski standard je istoveten z: EN ISO 18416:2009
ICS:
07.100.99 Drugi standardi v zvezi z Other standards related to
mikrobiologijo microbiology
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 18416
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - Detection of Candida albicans (ISO
18416:2007)
Cosmétiques - Microbiologie - Détection de Candida Kosmetik - Mikrobiologie - Nachweis von Candida albicans
albicans (ISO 18416:2007) (ISO 18416:2007)
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 18416:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
The text of ISO 18416:2007 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 18416:2009 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 18416:2007 has been approved by CEN as a EN ISO 18416:2009 without any modification.
INTERNATIONAL ISO
STANDARD 18416
First edition
2007-07-15
Cosmetics — Microbiology — Detection
of Candida albicans
Cosmétiques — Microbiologie — Détection de Candida albicans
Reference number
ISO 18416:2007(E)
©
ISO 2007
ISO 18416:2007(E)
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ii © ISO 2007 – All rights reserved
ISO 18416:2007(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Principle. 2
5 Diluents and culture media. 2
5.1 General. 2
5.2 Diluent for the yeast suspension (tryptone sodium chloride solution) . 3
5.3 Culture media . 3
6 Apparatus and glassware . 5
7 Strains of microorganisms . 5
8 Handling of cosmetic products and laboratory samples . 6
9 Procedure . 6
9.1 General recommendation . 6
9.2 Preparation of the initial suspension in the enrichment broth . 6
9.3 Incubation of the inoculated enrichment broth . 7
9.4 Detection and identification of Candida albicans . 7
10 Expression of the results (detection of Candida albicans) . 8
11 Neutralization of the antimicrobial properties of the product. 8
11.1 General. 8
11.2 Preparation of inoculum . 8
11.3 Validation of the detection method. 9
12 Test report . 9
Annex A (informative) Other media . 11
Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 15
Bibliography . 16
ISO 18416:2007(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 18416 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2007 – All rights reserved
ISO 18416:2007(E)
Introduction
Microbiological examinations of cosmetic products are carried out according to an appropriate microbiological
risk analysis in order to ensure their quality and safety for consumers.
Microbiological risk analysis depends on several parameters such as:
⎯ potential alteration of cosmetic products;
⎯ pathogenicity of microorganisms;
⎯ site of application of the cosmetic product (hair, skin, eyes, mucous membranes);
⎯ type of user (adults, children, including under 3 years).
For cosmetics and other topical products, the detection of Staphylococcus aureus, Pseudomonas aeruginosa
and Candida albicans may be relevant because they can cause skin or eye infections. The detection of other
kinds of microorganism might be of interest since those microorganisms (including indicators of faecal
contamination, e.g. Escherichia coli) suggest hygienic failure during the manufacturing process.
INTERNATIONAL STANDARD ISO 18416:2007(E)
Cosmetics — Microbiology — Detection of Candida albicans
1 Scope
This International Standard gives general guidelines for the detection and identification of the specified
microorganism Candida albicans in cosmetic products. Microorganisms considered as specified in this
International Standard might differ from country to country according to national practices or regulations.
In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate
microbiological risk analysis so as to determine the types of cosmetic product to which this International
Standard is applicable. Products considered to present a low microbiological risk include those with low water
activity, hydro-alcoholic products, those with extreme pH values, etc.
The method described in this International Standard is based on the detection of Candida albicans in a non-
selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods
may be appropriate dependent on the level of detection required.
NOTE For the detection of Candida albicans, subcultures can be performed on non-selective culture media followed
by suitable identification steps (e.g. using identification kits).
Because of the large variety of cosmetic products within this field of application, this method might not be
suited in every detail to some products (e.g. certain water-immiscible products). Other International Standards
(e.g. ISO 18415) might be appropriate. Other methods (e.g. automated) can be substituted for the test
presented here provided that their equivalence has been demonstrated or the method has been otherwise
validated.
2 Normative references
The following referenced docume
...
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