EN ISO 4973:2023

Cosmetics - Microbiology - Quality control of culture media and diluents used in cosmetics standards (ISO 4973:2023)

This document specifies the minimum requirements for quality control of microbiological culture media and diluents in order to demonstrate their ability to detect microorganisms and to ensure reliability of the microbiological test methods described in the ISO cosmetics microbiology standards.
This document describes mainly growth promotion and microbial control tests and is applicable to both commercially ready-to-use culture media and culture media prepared from dehydrated culture media or basic constituents in the user’s laboratory.
Other methods can be substituted provided that their equivalence has been demonstrated.

Kosmetische Mittel - Mikrobiologie - Qualitätskontrolle von Nährmedien und Verdünnungsmitteln, die in den Normen für kosmetischen Mittel verwendet werden (ISO 4973:2023)

Dieses Dokument legt die Mindestanforderungen an die Qualitätskontrolle mikrobiologischer Nährmedien und Verdünnungsmitteln fest, um deren Fähigkeit zum Nachweis von Mikroorganismen nachzuweisen und die Zuverlässigkeit der in den ISO Normen zur Mikrobiologie kosmetischer Mittel beschriebenen mikrobiologischen Untersuchungsverfahren sicherzustellen.
Dieses Dokument beschreibt hauptsächlich Untersuchungen auf Wachstumsförderung und zur mikrobiellen Kontrolle und ist sowohl für handelsübliche Fertignährmedien als auch für Nährmedien, die im Labor des Anwenders aus Trockennährmedien oder Grundbestandteilen hergestellt werden, anwendbar.
Andere Verfahren können ersatzweise verwendet werden, sofern ihre Gleichwertigkeit nachgewiesen wurde.

Cosmétiques - Microbiologie - Contrôle qualité des milieux de culture et des diluants utilisés dans les normes relatives aux cosmétiques (ISO 4973:2023)

Le présent document spécifie les exigences minimales relatives au contrôle qualité des milieux de culture microbiologique et des diluants afin de démontrer leur capacité à assurer la détection de micro-organismes et de garantir la fiabilité des méthodes d'essais microbiologiques décrites dans les normes ISO relatives à la microbiologie cosmétique.
Le présent document décrit principalement des essais de fertilité et de contrôle microbien; il est applicable à la fois aux milieux de culture prêts à l'emploi disponibles dans le commerce et aux milieux de culture préparés à partir de milieux de culture déshydratés ou de constituants de base dans le laboratoire de l'utilisateur.
D'autres méthodes peuvent être utilisées sous réserve que leur équivalence ait été démontrée.

Kozmetika - Mikrobiologija - Kontrola kakovosti gojišč in razredčil, ki se uporabljajo v standardih za kozmetiko (ISO 4973:2023)

Ta dokument določa minimalne zahteve za kontrolo kakovosti mikrobioloških gojišč in razredčil, da se dokaže njihova sposobnost zaznavanja mikroorganizmov in zagotovi zanesljivost mikrobioloških preskusnih metod, opisanih v mikrobioloških standardih ISO za kozmetiko. Dokument opisuje predvsem preskuse spodbujanja rasti in mikrobiološkega nadzora ter se uporablja tako za gojišča, ki so komercialno pripravljena za uporabo, kot gojišča, pripravljena iz dehidriranih gojišč ali osnovnih sestavin v uporabnikovem laboratoriju.
Druge metode je mogoče nadomestiti, če je bila dokazana njihova enakovrednost.

General Information

• Status: Published
• Publication Date: 03-Oct-2023
• ICS: 07.100.40 - Cosmetics microbiology
• Technical Committee: CEN/TC 392 - Cosmetics
• Drafting Committee: CEN/TC 392/WG 2 - Microbiological methods
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 04-Oct-2023
• Due Date: 16-Jul-2024
• Completion Date: 04-Oct-2023
• Ref Project: SIST EN ISO 4973:2023 - Cosmetics - Microbiology - Quality control of culture media and diluents used in cosmetics standards (ISO 4973:2023)

Standards Content (Sample)

SLOVENSKI STANDARD
01-december-2023
Kozmetika - Mikrobiologija - Kontrola kakovosti gojišč in razredčil, ki se
uporabljajo v standardih za kozmetiko (ISO 4973:2023)
Cosmetics - Microbiology - Quality control of culture media and diluents used in
cosmetics standards (ISO 4973:2023)
Kosmetische Mittel - Mikrobiologie - Qualitätskontrolle von Nährmedien und
Verdünnungsmitteln, die in den Normen für kosmetischen Mittel verwendet werden (ISO
4973:2023)
Cosmétiques - Microbiologie - Contrôle qualité des milieux de culture et des diluants
utilisés dans les normes relatives aux cosmétiques (ISO 4973:2023)
Ta slovenski standard je istoveten z: EN ISO 4973:2023
ICS:
07.100.40 Kozmetika - mikrobiologija Cosmetics microbiology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 4973
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2023
EUROPÄISCHE NORM
ICS 07.100.40
English Version
Cosmetics - Microbiology - Quality control of culture media
and diluents used in cosmetics standards (ISO 4973:2023)
Cosmétiques - Microbiologie - Contrôle qualité des Kosmetische Mittel - Mikrobiologie - Qualitätskontrolle
milieux de culture et des diluants utilisés dans les von Nährmedien und Verdünnungsmitteln, die in den
normes relatives aux cosmétiques (ISO 4973:2023) Normen für kosmetischen Mittel verwendet werden
(ISO 4973:2023)
This European Standard was approved by CEN on 26 September 2023.

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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4973:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 4973:2023) 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 April 2024, and conflicting national standards shall be
withdrawn at the latest by April 2024.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 4973:2023 has been approved by CEN as EN ISO 4973:2023 without any modification.

INTERNATIONAL ISO
STANDARD 4973
First edition
2023-09
Cosmetics — Microbiology — Quality
control of culture media and diluents
used in cosmetics standards
Cosmétiques — Microbiologie — Contrôle qualité des milieux
de culture et des diluants utilisés dans les normes relatives aux
cosmétiques
Reference number
ISO 4973:2023(E)
ISO 4973:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 4973:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principle . 3
4.1 General information. 3
4.2 pH . 3
4.3 Absence of microbiological growth . 3
4.4 Growth promotion. 3
4.5 Selective and indicative properties. 3
5 Diluents, neutralizers and culture media . 4
5.1 General . 4
5.2 Diluents and neutralizers . 4
5.3 Culture media . 4
6 Apparatus and glassware .4
7 Strains of microorganisms . 4
8 Procedure .6
8.1 General recommendation . 6
8.2 Preparation of strains . 6
8.2.1 General . 6
8.2.2 Preparation of bacterial and Candida albicans suspensions . 9
8.2.3 Preparation of Aspergillus brasiliensis spore stock suspension . 9
8.2.4 Control of the concentration of the calibrated suspension . 10
8.3 Absence of microbial growth . 10
8.3.1 Solid culture media . 10
8.3.2 Liquid culture media and diluents . 10
8.4 Growth promotion. 10
8.4.1 Solid culture media . 10
8.4.2 Liquid culture media . 11
8.5 Selective properties  . 11
8.5.1 Solid culture media — For indicative properties . 11
8.5.2 Solid culture media — For inhibition properties . 11
9 Expression of results .11
9.1 Absence of microbial growth . 11
9.1.1 Solid culture media . 11
9.1.2 Liquid culture media . 11
9.2 Growth promotion. 11
9.2.1 Solid culture media . 11
9.2.2 Liquid culture media . 11
9.3 Selective and indicative properties.12
9.3.1 Solid culture media — For indicative properties .12
9.3.2 Solid culture media — For inhibition properties .12
10 Interpretation and acceptance criteria .12
10.1 General .12
10.2 Absence of microbial growth .12
10.3 G
...