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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

Status
Withdrawn
Publication Date
16-Jun-2009
Withdrawal Date
15-Dec-2015
ICS
07.100.40 - Cosmetics microbiology
07.100.99 - Other standards related to microbiology
71.100.70 - Cosmetics. Toiletries
Technical Committee
CEN/TC 392 - Cosmetics
Drafting Committee
CEN/TC 392 - Cosmetics
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
16-Dec-2015
Mandate
M/426 - Standardisation mandate assigned to CEN concerning the microbiological analysis of cosmetic products
Ref Project
SIST EN ISO 18416:2009 - Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2007)

Relations

Replaced By
EN ISO 18416:2015 - Cosmetics - Microbiology - Detection of Candida albicans (ISO 18416:2015, Corrected version 2016-12-15)
Effective Date
23-Dec-2015

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 18416:2009
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
SIST EN ISO 18416:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 18416:2009

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SIST EN ISO 18416:2009
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.

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SIST EN ISO 18416:2009
EN ISO 18416:2009 (E)
Contents Page
Foreword .3

2

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SIST EN ISO 18416:2009
EN ISO 18416:2009 (E)
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.

3

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SIST EN ISO 18416:2009

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SIST EN ISO 18416:2009

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

---------------------- Page: 7 ----------------------

SIST EN ISO 18416:2009
ISO 18416:2007(E)
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