SIST EN ISO 16408:2025
(Main)Dentistry - Oral care products - Oral rinses (ISO 16408:2025)
Dentistry - Oral care products - Oral rinses (ISO 16408:2025)
This document specifies physical and chemical requirements and test methods for oral rinses. It also specifies requirements on the accompanying information to be given in the manufacturer's instructions for use and on containers as well as the requirements for packaging. Common labelling aspects are specified in order to enhance international understanding and trade.
This document is not applicable to other delivery systems (e.g. mouth sprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
This document is not applicable to oral rinses available by prescription only.
Zahnheilkunde - Mundhygieneprodukte - Mundspüllösungen und Mundwässer (ISO 16408:2025)
Dieses Dokument legt physikalische und chemische Anforderungen und Prüfverfahren für Mundspülungen fest. Es legt auch Anforderungen an die begleitenden Informationen fest, die in der Gebrauchsanweisung des Herstellers und auf den Behältnissen angegeben werden müssen, sowie die Anforderungen an die Verpackung. Es werden gemeinsame Aspekte der Kennzeichnung festgelegt, um das internationale Verständnis und den Handel zu verbessern.
Dieses Dokument ist nicht anwendbar auf andere Darreichungsformen (z. B. Mundspray, Schaum, Pulver). Es ist nicht beabsichtigt gesetzliche Vorgaben zu beschreiben, z. B. das Verschreibungsverfahren.
Dieses Dokument ist nicht anwendbar auf Mundspülungen und Mundwässer, die nur durch eine Verschreibung erhältlich sind.
Médecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche (ISO 16408:2025)
Le présent document spécifie les exigences physiques et chimiques ainsi que les méthodes d’essai applicables aux bains de bouche. Il spécifie également les exigences relatives aux informations d’accompagnement devant figurer dans les instructions du fabricant et sur les conteneurs, ainsi que les exigences relatives à l’emballage. Des caractéristiques communes en matière d’étiquetage sont spécifiées afin d’en améliorer la compréhension et de favoriser les échanges commerciaux à l’échelle internationale.
Le présent document n’est pas applicable aux autres formes de présentation (telles que sprays buccaux, mousses, poudres). Il ne vise pas à décrire les aspects réglementaires, tels que les règles de prescription.
Le présent document n’est pas applicable aux bains de bouche disponibles uniquement sur prescription médicale.
Zobozdravstvo - Izdelki za ustno nego - Sredstva za izpiranje ust (ISO 16408:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2025
Nadomešča:
SIST EN ISO 16408:2015
Zobozdravstvo - Izdelki za ustno nego - Sredstva za izpiranje ust (ISO 16408:2025)
Dentistry - Oral care products - Oral rinses (ISO 16408:2025)
Zahnheilkunde - Mundhygieneprodukte - Mundspüllösungen und Mundwässer (ISO
16408:2025)
Médecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche (ISO
16408:2025)
Ta slovenski standard je istoveten z: EN ISO 16408:2025
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 Kozmetika. Toaletni Cosmetics. Toiletries
pripomočki
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 16408
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2025
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 16408:2015
English Version
Dentistry - Oral care products - Oral rinses (ISO
16408:2025)
Médecine bucco-dentaire - Produits de soins bucco- Zahnheilkunde - Mundhygieneprodukte -
dentaires - Bains de bouche (ISO 16408:2025) Mundspüllösungen und Mundwässer (ISO
16408:2025)
This European Standard was approved by CEN on 30 June 2025.
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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16408:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 16408:2025) has been prepared by Technical Committee ISO/TC 106
"Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which
is held by DIN.
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 January 2026, and conflicting national standards shall
be withdrawn at the latest by January 2026.
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 16408:2015.
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 16408:2025 has been approved by CEN as EN ISO 16408:2025 without any modification.
International
Standard
ISO 16408
Third edition
Dentistry — Oral care products —
2025-06
Oral rinses
Médecine bucco-dentaire ― Produits de soins bucco-dentaires ―
Bains de bouche
Reference number
ISO 16408:2025(en) © ISO 2025
ISO 16408:2025(en)
© ISO 2025
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.
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Email: copyright@iso.org
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Published in Switzerland
ii
ISO 16408:2025(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 pH value .2
5.2 Total fluoride concentration and maximum amount of fluoride .2
5.3 Unintended heavy metal .2
5.4 Compatibility with oral tissues .2
5.5 Microbial contamination .2
5.6 Stability against ageing .3
5.7 Container and dispensing system .3
5.8 Readily fermentable carbohydrates .3
6 Sampling . 3
7 Test methods . 3
7.1 General .3
7.2 Visual inspection .3
7.3 Determination of pH value .3
7.4 Determination of total fluoride concentration and mass of ionic fluoride .3
7.4.1 General .3
7.4.2 Reagents .4
7.4.3 Apparatus .4
7.4.4 Preparation of sample solution .4
7.4.5 Sample analysis .4
7.4.6 Expression of results .4
7.5 Determination of stability against ageing .5
7.6 Pass/fail criteria . .5
8 Test report . 5
9 Accompanying information . 5
9.1 Manufacturer's instructions for use .5
9.2 Information on the primary container and on the secondary container if it exists .6
10 Packaging. 6
Bibliography . 7
iii
ISO 16408:2025(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may b
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