EN ISO 18415:2017
(Main)Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017)
Cosmetics - Microbiology - Detection of specified and non-specified microorganisms (ISO 18415:2017)
ISO 18415:2017 gives general guidelines for the detection and identification of specified microorganisms in cosmetic products as well as for the detection and identification of other kinds of aerobic mesophilic non-specified microorganisms in cosmetic products.
Microorganisms considered as specified in this document might differ from country to country according to national practices or regulations. Most of them considered as specified microorganisms include one or more of the following species: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans.
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.
The method described in this document is based on the detection of microbial growth in a non-selective liquid medium (enrichment broth) suitable to detect microbial contamination, followed by isolation of microorganisms on non-selective agar media. Other methods can be appropriate depending on the level of detection required.
In ISO 18415:2017 specific indications are given for identification of Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans. Other microorganisms that grow under the conditions described in this document may be identified by using suitable tests according to a general scheme (see Annex A). Other standards (e.g. ISO 18416, ISO 21150, ISO 22717, ISO 22718) may be appropriate.
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 methods (e.g. automated) can be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.
Kosmetische Mittel - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten Mikroorganismen (ISO 18415:2017)
Cosmétiques - Microbiologie - Détection des micro-organismes spécifiés et non spécifiés (ISO 18415:2017)
ISO 18416:2017 donne des lignes directrices générales pour la détection et l'identification de micro-organismes spécifiés dans les produits cosmétiques, et aussi pour la détection et l'identification d'autres sortes de micro-organismes mésophiles aérobies non spécifiés, dans les produits cosmétiques.
Les micro-organismes considérés comme spécifiés dans le présent document peuvent différer d'un pays à l'autre, suivant les pratiques ou réglementations nationales. La plupart des micro-organismes considérés comme spécifiés comprennent une ou plusieurs espèces, parmi les suivantes: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus et Candida albicans.
Pour garantir la qualité du produit et la sécurité des consommateurs, il est conseillé d'effectuer une analyse appropriée du risque microbiologique 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.
La méthode décrite dans le présent document est fondée sur la détection d'une croissance microbienne dans un milieu liquide non sélectif (bouillon d'enrichissement) qui permet de détecter une contamination microbienne, suivie d'un isolement des micro-organismes sur un milieu gélosé non sélectif. D'autres méthodes peuvent être appropriées, en fonction du niveau de détection exigé.
Dans le présent document, des indications spécifiques sont données pour l'identification de Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus et Candida albicans. D'autres micro-organismes qui se développent dans les conditions décrites dans le présent document peuvent être identifiés en mettant en ?uvre des essais appropriés conformes à un schéma général (voir Annexe A). D'autres Normes internationales (par exemple, l'ISO 18416, l'ISO 21150, l'ISO 22717 et l'ISO 22718) peuvent convenir.
En raison de la grande variété de produits cosmétiques relevant du présent domaine d'application, la présente méthode pourrait ne pas être, en tous points, applicable à certains produits (par exemple certains produits non miscibles à l'eau). D'autres méthodes (par exemple automatisées) peuvent se substituer aux essais présentés ici, sous réserve que leur équivalence ait été démontrée ou que la méthode ait été validée par ailleurs.
Kozmetika - Mikrobiologija - Ugotavljanje prisotnosti specifičnih in nespecifičnih mikroorganizmov (ISO 18415:2017)
Ta dokument podaja splošne smernice za ugotavljanje prisotnosti in identifikacijo specifičnih mikroorganizmov v kozmetičnih izdelkih ter ugotavljanje prisotnosti in identifikacijo drugih vrst aerobnih mezofilnih nespecifičnih mikroorganizmov v kozmetičnih izdelkih.
Mikroorganizmi, ki so v tem dokumentu obravnavani kot specifični, se lahko v različnih državah zaradi državnih praks ali predpisov razlikujejo. Večina od teh, ki so obravnavani kot specifični, vključuje eno ali več naslednjih vrst: Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus in Candida albicans.
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.
Metoda, opisana v tem dokumentu, temelji na ugotavljanju prisotnosti rasti mikrobov v neselektivnem tekočem gojišču (obogatitven bujon), primernem za ugotavljanje mikrobnega onesnaženja, ki mu sledi izolacija mikroorganizmov na neselektivnem agarskem gojišču. Ustrezne so lahko tudi druge metode, odvisno od zahtevane ravni ugotavljanja prisotnosti.
V tem dokumentu so podane specifične navedbe za identifikacijo vrst Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus in Candida albicans. Prisotnost drugih mikroorganizmov, ki rastejo pod pogoji, opisanimi v tem dokumentu, je mogoče ugotoviti z ustreznimi preskusi v skladu s splošno shemo (glej dodatek A). Primerni so lahko drugi standardi (npr. ISO 18416, ISO 21150, ISO 22717, ISO 22718).
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. avtomatizirane) lahko nadomestijo v tem dokumentu opisani preskusi, če je bila dokazana njihova enakovrednost ali je bila metoda kako drugače opredeljena kot primerna
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 18415:2011
.R]PHWLND0LNURELRORJLMD8JRWDYOMDQMHSULVRWQRVWLVSHFLILþQLKLQQHVSHFLILþQLK
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Cosmetics - Microbiology - Detection of specified and non-specified microorganisms
(ISO 18415:2017)
Kosmetische Mittel - Mikrobiologie - Nachweis von spezifizierten und nichtspezifizierten
Mikroorganismen (ISO 18415:2017)
Cosmétiques - Microbiologie - Détection des micro-organismes spécifiés et non spécifiés
(ISO 18415:2017)
Ta slovenski standard je istoveten z: EN ISO 18415:2017
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 18415
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2017
EUROPÄISCHE NORM
ICS 07.100.40 Supersedes EN ISO 18415:2011
English Version
Cosmetics - Microbiology - Detection of specified and non-
specified microorganisms (ISO 18415:2017)
Cosmétiques - Microbiologie - Détection des micro- Kosmetische Mittel - Mikrobiologie - Nachweis von
organismes spécifiés et non spécifiés (ISO 18415:2017) spezifizierten und nichtspezifizierten
Mikroorganismen (ISO 18415:2017)
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 18415:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 18415:2017) 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 18415:2011.
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 18415:2017 has been approved by CEN as EN ISO 18415:2017 without any modification.
INTERNATIONAL ISO
STANDARD 18415
Second edition
2017-06
Cosmetics — Microbiology —
Detection of specified and non-
specified microorganisms
Cosmétiques — Microbiologie — Détection des micro-organismes
spécifiés et non spécifiés
Reference number
ISO 18415:2017(E)
©
ISO 2017
ISO 18415:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ISO 18415:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 3
5 Diluents and culture media . 3
5.1 General . 3
5.2 Diluent for the microbial suspension (tryptone sodium chloride solution) . 3
5.2.1 General. 3
5.2.2 Composition . 4
5.2.3 Preparation . 4
5.3 Culture media . 4
5.3.1 General. 4
5.3.2 Enrichment broth . 4
5.3.3 Non-selective agar medium . 5
6 Apparatus and glassware . 5
7 Strains of microorganism . 6
8 Handling of cosmetic products and laboratory samples . 6
9 Procedure. 6
9.1 General recommendations. 6
9.2 Preparation of the initial suspension in the enrichment broth . 6
9.2.1 General. 6
9.2.2 Water-miscible products. 7
9.2.3 Water-immiscible products . 7
9.2.4 Filterable products . 7
9.3 Incubation of the initial suspension . 7
9.4 Isolation of specified and non-specified microorganisms . 7
9.5 Procedure for identification of the specified microorganism: Pseudomonas aeruginosa . 7
9.5.1 Gram staining . 7
9.5.2 Oxidase test . 7
9.5.3 Identification test . 8
9.6 Procedure for identification of the specified microorganism: Escherichia coli . 8
9.6.1 Gram staining . 8
9.6.2 Oxidase test . 8
9.6.3 Identification test . 8
9.7 Procedure for identification of the specified microorganism: Staphylococcus aureus . 8
9.7.1 Gram staining . 8
9.7.2 Catalase test . 8
9.7.3 Identification test . 8
9.8 Procedure for the identification of the specified microorganism: Candida albicans . 9
9.8.1 Gram staining . 9
9.8.2 Identification test . 9
9.9 Procedure for the identification of non-specified microorganisms . 9
9.9.1 Gram staining . 9
9.9.2 Oxidase test . 9
9.9.3 Catalase test . 9
9.9.4 Identification test . 9
10 Expression of the results .
...
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