EN ISO 16212:2011
(Main)Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2008)
Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2008)
ISO 16212:2008 gives general guidelines for enumeration of yeast and mould present in cosmetics, by counting the colonies on selective agar medium after aerobic incubation.
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 products to which ISO 16212:2008 is applicable. Products considered to present a low microbiological risk include those with low water activity, hydro-alcoholic products, extreme pH values, etc.
Kosmetik - Mikrobiologie - Zählung von Hefen und Schimmelpilzen (ISO 16212:2008)
Diese Internationale Norm gibt allgemeine Anleitungen für die Zählung von in Kosmetika vorhandenen Hefen und Schimmelpilzen durch Zählen der Kolonien auf einem selektiven Agarmedium nach aerober Bebrütung.
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, auf die diese Internationale Norm anwendbar ist. Produkte, die ein geringes mikrobiologisches Risiko darstellen, um-fassen Produkte mit geringer Wasseraktivität, alkoholisch wässrige Produkte, Produkte mit extremen pH Wer-ten usw.
Wegen der großen Vielfalt an kosmetischen Mitteln innerhalb dieses Anwendungsbereiches ist dieses Verfahren möglicherweise für einige Produkte nicht in allen Einzelheiten geeignet (z. B. bestimmte mit Wasser nicht mischbare Produkte). Für die hier aufgeführten Untersuchungen können andere Verfahren (z. B. automatisierte) zur Anwendung kommen, vorausgesetzt, dass deren Gleichwertigkeit nachgewiesen oder das Verfahren anderweitig validiert wurde.
Ausgezählte Hefen können mit geeigneten Identifizierungsprüfungen bestimmt werden, zum Beispiel Prüfungen, die in den unter den Literaturhinweisen aufgeführten Normen beschrieben sind. Falls notwendig, können ausgezählte Schimmelpilze nach anderen geeigneten Verfahren identifiziert werden.
Cosmétiques - Microbiologie - Dénombrement des levures et des moisissures (ISO 16212:2008)
L'ISO 16212:2008 donne des lignes directrices générales pour le dénombrement des levures et des moisissures présentes dans les cosmétiques par comptage des colonies en milieu gélosé sélectif après une incubation aérobie.
Afin de garantir la qualité du produit et la sécurité des consommateurs, il est conseillé d'effectuer une analyse de risque microbiologique pour déterminer les types de produits cosmétiques auxquels l'ISO 16212:2008 s'applique. Les produits considérés comme présentant un faible risque microbiologique comprennent ceux ayant une faible activité de l'eau, les produits hydro-alcooliques, les produits ayant des valeurs de pH extrêmes, etc.
Kozmetika - Mikrobiologija - Ugotavljanje števila kvasovk in plesni (ISO 16212:2008)
Ta mednarodni standard podaja splošne smernice za ugotavljanje števila kvasovk in plesni, prisotnih v kozmetiki, s štetjem kolonij na selektivnem agarskem gojišču po aerobni inkubaciji. Za zagotavljanje kakovosti izdelka in varnosti za potrošnike je priporočljivo opraviti ustrezno analizo mikrobiološkega tveganja, da se določijo vrste kozmetičnih izdelkov, za katere velja ta mednarodni standard. Izdelki, za katere velja, da predstavljajo nizko mikrobiološko tveganje, vključujejo izdelke z nizko aktivnostjo vode, hidroalkoholne izdelke, izdelke z ekstremnimi vrednostmi pH itd. Zaradi velike raznolikosti kozmetičnih izdelkov v tem okviru uporabe ta metoda za nekatere izdelke morda ni primerna v vsaki podrobnosti (npr. za nekatere izdelke, ki se ne mešajo z vodo). Pri tu predstavljenem preskusu se lahko uporabijo druge metode (npr. avtomatske), pod pogojem, da je bila dokazana njihova enakovrednost ali da je bila metoda kako drugače validirana. Preštete kvasovke se lahko identificirajo s primernimi identifikacijskimi preskusi, na primer s preskusi, opisanimi v standardih, navedenih v bibliografiji. Preštete plesni se lahko po potrebi identificirajo z drugimi ustreznimi metodami.
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2011
Kozmetika - Mikrobiologija - Ugotavljanje števila kvasovk in plesni (ISO
16212:2008)
Cosmetics - Microbiology - Enumeration of yeast and mould (ISO 16212:2008)
Kosmetik - Mikrobiologie - Zählung von Hefen und Schimmelpilzen (ISO 16212:2008)
Cosmétiques - Microbiologie - Dénombrement des levures et des moisissures (ISO
16212:2008)
Ta slovenski standard je istoveten z: EN ISO 16212:2011
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 16212
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2011
ICS 71.100.70
English Version
Cosmetics - Microbiology - Enumeration of yeast and mould
(ISO 16212:2008)
Cosmétiques - Microbiologie - Dénombrement des levures Kosmetik - Mikrobiologie - Zählung von Hefen und
et des moisissures (ISO 16212:2008) Schimmelpilzen (ISO 16212:2008)
This European Standard was approved by CEN on 12 May 2011.
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-CENELEC 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-CENELEC Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16212:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Foreword
The text of ISO 16212:2008 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 16212:2011 by
Technical Committee CEN/TC 392 “Cosmetics” the secretariat of which is held by NEN.
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 2011, and conflicting national standards shall be withdrawn
at the latest by December 2011.
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, Croatia, 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 16212:2008 has been approved by CEN as a EN ISO 16212:2011 without any modification.
INTERNATIONAL ISO
STANDARD 16212
First edition
2008-10-15
Cosmetics — Microbiology —
Enumeration of yeast and mould
Cosmétiques — Microbiologie — Dénombrement des levures et des
moisissures
Reference number
ISO 16212:2008(E)
©
ISO 2008
ISO 16212:2008(E)
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ii © ISO 2008 – All rights reserved
ISO 16212:2008(E)
Contents Page
Foreword. iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 Principles. 2
4.1 General. 2
4.2 Plate count. 2
4.3 Membrane filtration. 2
5 Diluents, neutralizers and culture media. 3
5.1 General. 3
5.2 Neutralizing diluents and diluents . 3
5.3 Diluent for yeast suspension (tryptone sodium chloride solution). 4
5.4 Culture media . 4
6 Apparatus and glassware . 5
7 Strain 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. 6
9.3 Counting methods . 6
10 Counting of colonies (plate counts and membrane filtration methods). 7
11 Expression of results . 8
11.1 Method of calculation for plate count. 8
11.2 Interpretation. 8
12 Neutralization of the antifungicidal properties of the product. 10
12.1 General. 10
12.2 Preparation of inoculum . 10
12.3 Validation of counting methods. 11
13 Test report . 12
Annex A (informative) Other neutralizing diluents . 13
Annex B (informative) Other diluents. 15
Annex C (informative) Other culture media . 16
Annex D (informative) Neutralizers of antifungicidal activity of preservatives and rinsing liquids . 18
Bibliography . 19
ISO 16212:2008(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 16212 was prepared by Technical Committee ISO/TC 217, Comestics.
iv © ISO 2008 – All rights reserved
INTERNATIONAL STANDARD ISO 16212:2008(E)
Cosmetics — Microbiology — Enumeration of yeast and mould
1 Scope
This International Standard gives general guidelines for enumeration of yeast and mould present in cosmetics
by counting the colonies on selective agar medium after aerobic incubation.
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 products to which this International
Standard is applicable. Products considered to present a low microbiological risk include those with low water
activity, hydro-alcoholic products, products with extreme pH values, etc.
Because of the large variety of cosmetic products within this field of application, this method might not be
suited to some products in every detail (e.g. certain water-immiscible products). Other methods (e.g.
automated) can be used for the test presented here provided that their equivalence has been demonstrated or
the method has been otherwise validated.
Yeast enumerated can be identified using suitable identification tests, for example tests described in the
standards listed in the Bibliography. Mould enumerated can be identified by other appropriate methods, if
necessary.
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 21148, Cosmetics — Microbiology — General instructions for microbiological examination
EN 12353, Chemical disinfectants and antiseptics — Preservation of test organisms used for the
determination of bactericidal, mycobactericidal, sporicidal and fungicidal activity
3 Terms and defi
...
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