SIST EN ISO 22717:2009
(Main)Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (ISO 22717:2006)
Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (ISO 22717:2006)
This International Standard gives general guidelines for the detection and identification of the specified micro-organism Pseudomonas aeruginosa in cosmetic products. Micro-organisms 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 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, extreme pH values, etc. The method described in this International Standard is based on the detection of Pseudomonas aeruginosa in a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other methods may be appropriate, depending on the level of detection required.
Kosmetik - Mikrobiologie - Nachweis von Pseudomonas aeruginosa (ISO 22717:2006)
Diese Internationale Norm gibt allgemeine Anleitungen für den Nachweis und die Identifizierung des vorgege-benen Mikroorganismus Pseudomonas aeruginosa in kosmetischen Mitteln. Die in dieser Internationalen Norm vorgegebenen 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 gültig 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 Pseudomonas aeruginosa in einem nicht selektiven Flüssigmedium (Anreicherungsbouillon), gefolgt von einer Isolation auf einem selektiven Agarmedium. In Abhängigkeit von der erforderlichen Nachweisgrenze können andere Verfahren angemessen sein.
ANMERKUNG Für den Nachweis von Pseudomonas aeruginosa 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 (ISO 18415 [10]) können zutreffen. 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 - Recherche de Pseudomonas aeruginosa (ISO 22717:2006)
L'ISO 22717:2007 donne des lignes directrices générales pour la recherche et l'identification du microorganisme spécifié Pseudomonas aeruginosa dans les produits cosmétiques. Les microorganismes considérés comme spécifiés dans la présente Norme internationale peuvent différer d'un pays à un autre, suivant les pratiques ou les réglementations nationales.
Pour garantir la qualité du produit et la sécurité des consommateurs, il est recommandé d'effectuer une analyse appropriée du risque microbiologique afin de déterminer les types de produit cosmétique qui relèvent de l'ISO 22717:2007. Les produits dont on considère qu'ils présentent un faible risque microbiologique comprennent ceux ayant une faible activité de l'eau, les produits hydroalcooliques, ceux ayant des valeurs de pH extrêmes, etc.
La méthode décrite dans l'ISO 22717:2007 repose sur la recherche de Pseudomonas aeruginosa dans un milieu liquide non sélectif (milieu liquide d'enrichissement), suivie de son isolement sur un milieu gélosé sélectif. D'autres méthodes peuvent être appropriées, en fonction du niveau de détection requis.
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Pseudomonas aeruginosa (ISO 22717:2006)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 22717:2009
01-oktober-2009
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti bakterije Pseudomonas
aeruginosa (ISO 22717:2006)
Cosmetics - Microbiology - Detection of Pseudomonas aeruginosa (ISO 22717:2006)
Kosmetik - Mikrobiologie - Nachweis von Pseudomonas aeruginosa (ISO 22717:2006)
Cosmétiques - Microbiologie - Recherche de Pseudomonas aeruginosa (ISO
22717:2006)
Ta slovenski standard je istoveten z: EN ISO 22717:2009
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 22717:2009 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 22717:2009
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SIST EN ISO 22717:2009
EUROPEAN STANDARD
EN ISO 22717
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 07.100.99; 71.100.70
English Version
Cosmetics - Microbiology - Detection of Pseudomonas
aeruginosa (ISO 22717:2006)
Cosmétiques - Microbiologie - Recherche de Pseudomonas Kosmetik - Mikrobiologie - Nachweis von Pseudomonas
aeruginosa (ISO 22717:2006) aeruginosa (ISO 22717:2006)
This European Standard was approved by CEN on 30 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 22717:2009: E
worldwide for CEN national Members.
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SIST EN ISO 22717:2009
EN ISO 22717:2009 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 22717:2009
EN ISO 22717:2009 (E)
Foreword
The text of ISO 22717:2006 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 22717:2009.
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 22717:2006 has been approved by CEN as a EN ISO 22717:2009 without any modification.
3
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SIST EN ISO 22717:2009
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SIST EN ISO 22717:2009
INTERNATIONAL ISO
STANDARD 22717
First edition
2006-02-01
Cosmetics — Microbiology — Detection
of Pseudomonas aeruginosa
Cosmétiques — Microbiologie — Détection de Pseudomonas
aeruginosa
Reference number
ISO 22717:2006(E)
©
ISO 2006
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SIST EN ISO 22717:2009
ISO 22717:2006(E)
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ii © ISO 2006 – All rights reserved
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SIST EN ISO 22717:2009
ISO 22717:2006(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 bacterial suspension (tryptone sodium chloride solution). 3
5.3 Culture media . 3
6 Apparatus and glassware . 5
7 Strains of micro-organisms . 6
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 Pseudomonas aeruginosa . 7
10 Expression of results . 8
11 Neutralization of the antimicrobial properties of the product. 8
11.1 General. 8
11.2 Preparation of the inoculum . 8
11.3 Validation of the detection method. 8
12 Test report . 9
Annex A (informative) Other enrichment broths. 10
Annex B (informative) Neutralizers of antimicrobial activity of preservatives and rinsing liquids . 12
Bibliography . 13
© ISO 2006 – All rights reserved iii
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SIST EN ISO 22717:2009
ISO 22717:2006(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 22717 was prepared by Technical Committee ISO/TC 217, Cosmetics.
iv © ISO 2006 – All rights reserved
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SIST EN ISO 22717:2009
ISO 22717:2006(E)
Introduction
Microbiological examinations of cosmetic products shall be 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 micro-organisms;
⎯ site of application of the cosmetic product (hair, skin, eyes, mucous membranes, etc.);
⎯ type of users (adults, children under 3 years).
For cosmetics and other topical products, the detection of skin pathogens such as Staphylococcus aureus,
Pseudomonas aeruginosa and Candida albicans may be relevant. The detection of other kinds of
micro-organism might be of interest since these micro-organisms (including indicators of faecal contamination
e.g. Escherichia coli) suggest hygienic failure during the manufacturing process.
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SIST EN ISO 22717:2009
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SIST EN ISO 22717:2009
INTERNATIONAL STANDARD ISO 22717:2006(E)
Cosmetics — Microbiology — Detection of Pseudomonas
aeruginosa
1 Scope
This International Standard gives general guidelines for the detection and identification of the specified
micro-organism Pseudomonas aeruginosa in cosmetic products. Micro-organisms 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 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, extreme pH values, etc.
The method described in this International Standard is based on the detection of Pseudomonas aeruginosa in
a non-selective liquid medium (enrichment broth), followed by isolation on a selective agar medium. Other
methods may be appropriate, depending on the level of detection required.
NOTE For the detection of Pseudomonas aeruginosa, 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 may not be
appropriate in every detail for some products (e.g. certain water immiscible products). Other International
[10]
Standards (ISO 18415 ) may be appropriate. 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.
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 21148:2005, Cosmetics — Microbiology — General instructions for microbiological examination
EN 12353, Chemical disinfectants and antiseptics — Preservation of microbial strains used for the
determination of bactericidal and fungicidal activity
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
product
portion of an identified cosmetic product received in the laboratory for testing
3.2
sample
portion of the product (at least 1 g or 1 ml) that is used in the test to prepare the initial suspension
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SIST EN ISO 22717:2009
ISO 22717:2006(E)
3.3
initial suspension
suspension (or solution) of the sample in a defined volume of an appropriate enrichment broth
3.4
sample dilution(s)
dilution(s) of the initial suspension
3.5
specified micro-organism
aerobic mesophilic bacteria or yeast that is undesirable in a cosmetic product and is recognized as a skin
pathogen species that may be harmful for human health or as indication of hygienic failure in the
manufacturing process
3.6
Pseudomonas aeruginosa
Gram-negative rod, motile; smooth colonies pigmented brown or greenish
NOTE 1 The main characteristics for identification are: growth on selective cetrimide agar medium, oxidase positive,
production of diffusible fluorescent pigments and production of a soluble phenazine pigment (pyocyanin) in suitable media.
NOTE 2 Pseudomonas aeruginosa may be isolated from a wide variety of environmental sources, especially in water
and has a very high potential to spoil many different substrates. It may produce infections of human skin or eye area. It is
undesirable in cosmetic products for its potential pathogenicity and its capacity to affect the physico-chemical properties of
the cosmetic formula.
3.7
enrichment broth
non-selective liquid medium containing suitable neutralizers and/or dispersing agents and validated for the
product under test
4 Principle
The first step of the procedure is to perform an enrichment by using a non-selective broth medium to increase
the number of micro-organisms without the risk of inhibition by the selective ingredients that are present in
selective/differential growth media.
The second step of the test (isolation) is performed on a selective medium followed by identification tests.
The possible inhibition of microbial growth by the sample shall be neutralized to allow the detection of viable
[1]
micro-organisms . In all cases and whatever the methodology, the neutralization of the antimicrobial
[2], [3], [4]
properties of the product shall be checked and validated .
5 Diluents and culture media
5.1 General
General instructions are given in ISO 21148. When water is mentioned in this document, use distilled water or
purified water as specified in ISO 21148.
The enrichment broth is used to disperse the sample and to increase the initial microbial population. It may
contain neutralizers if the specimen to be tested has antimicrobial properties. The efficacy of the neutralization
shall be demonstrated (see Clause 11). Information relative to suitable neutralizers is given in Annex B.
The following enrichment broth is suitable for checking the presence of Pseudomonas aeruginosa in
accordance with this International Standard provided that it is validated in accordance with Clause 11.
Other diluents and culture media may be used if they can be demonstrated to be suitable for use.
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SIST EN ISO 22717:2009
ISO 22717:2006(E)
5.2 Diluent for the bacterial suspension (tryptone sodium chloride solution)
5.2.1 General
The diluent is used for the preparation of bacterial suspension used for the validation procedure
(see Clause 11).
5.2.2 Composition
⎯ tryptone, pancreatic digest of casein 1,0 g
⎯ sodium chloride 8,5 g
⎯ water 1 000 ml
5.2.3 Preparation
Dissolve the components in water by mixing whilst heating. Dispense into suitable containers. Sterilize in the
autoclave at 121 °C for 15 min.
After sterilization and cooling down, the pH shall be equivalent to 7,0 ± 0,2 when measured at room
temperature.
5.3 Culture media
5.3.1 General
Culture media may be prepared using the descriptions provided below or from dehydrated culture media
according to the instructions of the manufacturer. The instructions provided by the supplier of the media
should be followed.
NOTE Ready to use media may be used when their composition and/or growth yields are comparable to those of the
formulas given herein.
5.3.2 Agar medium for validation (soybean–casein digest agar
...
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