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EN ISO 21148:2017

(Main)

Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017)

Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017)

ISO 21148:2017 gives general instructions for carrying out microbiological examinations of cosmetic products, in order to ensure their quality and safety, in accordance with an appropriate risk analysis (e.g. low water activity, hydro-alcoholic, extreme pH values).
Because of the large variety of products and potential uses within this field of application, these instructions might not be appropriate for some products in every detail (e.g. certain water-immiscible products).

Kosmetische Mittel - Mikrobiologie - Allgemeine Anleitungen zur mikrobiologischen Untersuchung (ISO 21148:2017)

Dieses Dokument gibt allgemeine Anleitungen für die Durchführung von mikrobiologischen Unter-suchungen kosmetischer Mittel, damit deren Qualität und Sicherheit in Übereinstimmung mit einer entsprechenden Risikoanalyse (z. B. geringe Wasseraktivität, hydroalkoholischer Anteil, extreme pH Werte) sichergestellt ist.
Wegen der großen Vielfalt an kosmetischen Mitteln und potentiellen Anwendungsmöglichkeiten innerhalb dieses Anwendungsbereichs sind diese Anleitungen möglicherweise für einige Produkte nicht in allen Einzelheiten geeignet (z. B. bestimmte mit Wasser nicht mischbare Produkte).

Cosmétiques - Microbiologie - Instructions générales pour les examens microbiologiques (ISO 21148:2017)

ISO 21148:2017 donne des règles générales pour la réalisation d'examens microbiologiques sur des produits cosmétiques afin de garantir leur qualité et leur innocuité, conformément à une analyse de risque appropriée (par exemple faible activité de l'eau, produit hydro-alcoolique, valeurs de pH extrêmes).
En raison de la grande variété de produits entrant dans le champ d'application de la présente norme et de leurs usages potentiels, ces règles peuvent ne pas être adaptées en tout point à certains produits (par exemple produits non miscibles à l'eau).

Kozmetika - Mikrobiologija - Splošna navodila za mikrobiološko preskušanje (ISO 21148:2017)

V tem dokumentu so podana splošna navodila za izvajanje mikrobioloških pregledov kozmetičnih izdelkov, da se zagotovi njihova kakovost in varnost v skladu z ustrezno analizo tveganja (npr. izdelkov z nizko aktivnostjo vode ali s skrajnimi vrednostmi pH, hidro-alkoholnih izdelkov).
Zaradi velike raznolikosti izdelkov in možnosti njihove uporabe na tem področju uporabe ta navodila morda niso v celoti primerna za nekatere izdelke (npr. tiste, ki se ne mešajo z vodo).

General Information

Status
Published
Publication Date
20-Jun-2017
Withdrawal Date
30-Dec-2017
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
21-Jun-2017
Completion Date
21-Jun-2017
Mandate
M/426 - Standardisation mandate assigned to CEN concerning the microbiological analysis of cosmetic products
Ref Project
SIST EN ISO 21148:2017 - Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2017)

Relations

Replaces
EN ISO 21148:2009 - Cosmetics - Microbiology - General instructions for microbiological examination (ISO 21148:2005)
Effective Date
31-Aug-2016

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SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 21148:2009
Kozmetika - Mikrobiologija - Splošna navodila za mikrobiološko preskušanje (ISO
21148:2017)
Cosmetics - Microbiology - General instructions for microbiological examination (ISO
21148:2017)
Kosmetische Mittel - Mikrobiologie - Allgemeine Anleitungen zur mikrobiologischen
Untersuchung (ISO 21148:2017)
Cosmétiques - Microbiologie - Instructions générales pour les examens microbiologiques
(ISO 21148:2017)
Ta slovenski standard je istoveten z: EN ISO 21148:2017
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21148
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2017
EUROPÄISCHE NORM
ICS 07.100.99; 71.100.70 Supersedes EN ISO 21148:2009
English Version
Cosmetics - Microbiology - General instructions for
microbiological examination (ISO 21148:2017)
Cosmétiques - Microbiologie - Instructions générales Kosmetische Mittel - Mikrobiologie - Allgemeine
pour les examens microbiologiques (ISO 21148:2017) Anleitungen zur mikrobiologischen Untersuchung (ISO
21148:2017)
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 21148:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21148:2017) 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 21148:2009.
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 21148:2017 has been approved by CEN as EN ISO 21148:2017 without any modification.

INTERNATIONAL ISO
STANDARD 21148
Second edition
2017-06
Cosmetics — Microbiology — General
instructions for microbiological
examination
Cosmétiques — Microbiologie — Instructions générales pour les
examens microbiologiques
Reference number
ISO 21148:2017(E)
©
ISO 2017
ISO 21148:2017(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
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 21148:2017(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Premises . 1
4.1 Test areas . 1
4.2 Additional areas . 2
4.3 Location of the premises . 2
4.4 Equipping the premises . 2
4.5 Maintenance . 3
5 Equipment . 3
5.1 General . 3
5.2 Microbiological cabinets . 3
5.3 Balances . 3
5.4 Homogenizer . 4
5.5 pH–meter . 4
5.6 Autoclave . 4
5.7 Incubator . 4
5.8 Water baths . 4
5.9 Refrigerator or cold-storage room . 4
5.10 Freezer . 4
5.11 Sterilizing oven . 5
5.12 Colony-counting device . 5
5.13 Other equipment . 5
6 Strains of microorganisms . 5
7 Personnel . 6
7.1 Competence . 6
7.2 Hygiene . 6
8 Preparation of the apparatus and glassware . 6
8.1 Preparation . 6
8.2 Sterilization . 6
8.2.1 Sterilization by dry heat . 6
8.2.2 Sterilization by moist heat . 7
8.3 Disposable apparatus . 7
8.4 Management of clean apparatus and glassware . 7
8.5 Management of sterile apparatus and glassware . 7
8.6 Treatment of contaminated material . 7
8.7 Washing . 7
9 Preparation and sterilization of culture media and reagents . 8
9.1 General . 8
9.2 Water . 8
9.3 Preparation of culture media . 8
9.3.1 General.
...

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