EN ISO 21149:2017
(Main)Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2017)
Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria (ISO 21149:2017)
ISO 21149:2017 gives general guidelines for enumeration and detection of aerobic mesophilic 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 shown to be suitable.
If needed, microorganisms enumerated or detected may be identified using suitable identification tests described in the standards given in the Bibliography.
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 products to which this document is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity, hydro-alcoholic products, extreme pH values, etc.
Kosmetische Mittel - Mikrobiologie - Zählung und Nachweis von aeroben mesophilen Bakterien (ISO 21149:2017)
Dieses Dokument gibt allgemeine Anleitungen für die Zählung und zum Nachweis von in Kosmetischen Mitteln 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 kann dieses Verfahren nicht zwangsläufig bis in alle Einzelheiten auf bestimmte Mittel anwendbar sein (z. B. bestimmte mit Wasser nicht mischbare Produkte). Ersatzweise dürfen 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.
Falls erforderlich, dürfen 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 dieses Dokument anwendbar ist. Produkte, die ein geringes mikrobiologisches Risiko darstellen, um¬fassen jene mit geringer Wasseraktivität, alkoholisch wässrige Produkte, Produkte mit extremen pH Wer¬ten usw.
Cosmétiques - Microbiologie - Dénombrement et détection des bactéries aérobies mésophiles (ISO 21149:2017)
ISO 21149:2017 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, applicable 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 en Bibliographie.
Pour garantir la qualité du produit et la sécurité des consommateurs, il est conseillé d'effectuer une analyse de risque microbiologique appropriée, afin de déterminer les types de produits cosmétiques qui relèvent du présent document. 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 prisotnosti in števila aerobnih mezofilnih bakterij (ISO 21149:2017)
Ta dokument podaja splošne smernice za ugotavljanje prisotnosti in števila aerobnih mezofilnih bakterij v kozmetičnih izdelkih:
– s štetjem kolonij na agarskem gojišču po aerobni inkubaciji, ali
– s preverjanjem odsotnosti bakterijske rasti po obogatitvi.
Zaradi velike raznolikosti kozmetičnih izdelkov na tem področju uporabe ta metoda morda ni v celoti primerna za nekatere izdelke (npr. tiste, ki se ne mešajo z vodo). Druge metode (npr. avtomatske) je mogoče zamenjati za tukaj predstavljene preskuse, če je bila dokazana njihova enakovrednost ali je bila metoda drugače dokazana za primerno.
Po potrebi se lahko za ugotavljanje prisotnosti in števila mikroorganizmov uporabijo ustrezni identifikacijski preskusi, opisani v standardih, navedenih v bibliografiji.
Za zagotovitev kakovosti in varnosti izdelkov za stranke je priporočljivo izvesti ustrezno mikrobiološko analizo tveganja, s katero se določijo vrste kozmetičnih izdelkov, za katere se uporablja ta dokument. Izdelki, ki po ocenah predstavljajo nizko mikrobiološko tveganje (glej ISO 29621), vključujejo izdelke z nizko aktivnostjo vode ali s skrajnimi vrednostmi pH, hidro-alkoholne izdelke itd.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 21149:2009
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti in števila aerobnih mezofilnih
bakterij (ISO 21149:2017)
Cosmetics - Microbiology - Enumeration and detection of aerobic mesophilic bacteria
(ISO 21149:2017)
Kosmetische Mittel - Mikrobiologie - Zählung und Nachweis von aeroben mesophilen
Bakterien (ISO 21149:2017)
Cosmétiques - Microbiologie - Dénombrement et détection des bactéries aérobies
mésophiles (ISO 21149:2017)
Ta slovenski standard je istoveten z: EN ISO 21149:2017
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 21149
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2017
EUROPÄISCHE NORM
ICS 71.100.70; 07.100.99 Supersedes EN ISO 21149:2009
English Version
Cosmetics - Microbiology - Enumeration and detection of
aerobic mesophilic bacteria (ISO 21149:2017)
Cosmétiques - Microbiologie - Dénombrement et Kosmetische Mittel - Mikrobiologie - Zählung und
détection des bactéries aérobies mésophiles (ISO Nachweis von aeroben mesophilen Bakterien (ISO
21149:2017) 21149:2017)
This European Standard was approved by CEN on 26 April 2017.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21149:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 21149:2017) has been prepared by Technical Committee ISO/TC 217
“Cosmetics” in collaboration with Technical Committee CEN/TC 392 “Cosmetics” the secretariat of
which is held by AFNOR.
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 2017, and conflicting national standards
shall be withdrawn at the latest by December 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 21149:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 21149:2017 has been approved by CEN as EN ISO 21149:2017 without any modification.
INTERNATIONAL ISO
STANDARD 21149
Second edition
2017-06
Cosmetics — Microbiology —
Enumeration and detection of aerobic
mesophilic bacteria
Cosmétiques — Microbiologie — Dénombrement et détection des
bactéries aérobies mésophiles
Reference number
ISO 21149:2017(E)
©
ISO 2017
ISO 21149:2017(E)
© ISO 2017, Published in Switzerland
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ISO 21149:2017(E)
Contents Page
Foreword .v
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 . 7
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
9.2.1 General. 7
9.2.2 Water-miscible products. 8
9.2.3 Water-immiscible products . 8
9.3 Counting methods . 8
9.3.1 Dilutions for counting methods . 8
9.3.2 Plate-count methods . 8
9.4 Enrichment . 9
9.4.1 General. 9
9.4.2 Incubation of the sample . 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 .11
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 Suitability of counting methods .14
13.3.1 Principle .14
13.3.2 Suitability test of the pour-plate method .14
13.3.3 Suitability of the surface spread method .14
13.3.4 Suitability of the membrane filtration method .14
13.4 Suitability of the detection method by enrichment .15
13.4.1 Procedure .15
13.4.2 Interpretation of results .15
13.5 Interpretation of suitability test results .
...
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