prEN ISO 16408
(Main)Dentistry - Oral care products - Oral rinses (ISO/DIS 16408:2024)
Dentistry - Oral care products - Oral rinses (ISO/DIS 16408:2024)
ISO 16408:2015 specifies physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as the manufacturer's instructions for use, marking, and/or labelling requirements.
ISO 16408:2015 is not applicable to other delivery systems (e.g. mouthsprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription.
ISO 16408:2015 is not applicable to oral rinses available by prescription only.
Zahnheilkunde - Mundhygieneprodukte - Mundspüllösungen und Mundwässer (ISO/DIS 16408:2024)
Médecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche (ISO/DIS 16408:2024)
ISO 16408:2015 spécifie les exigences physiques et chimiques ainsi que les méthodes d'essai applicables aux bains de bouche. Elle spécifie également la documentation jointe, telle que la notice du fabricant, et les exigences de marquage et/ou d'étiquetage.
ISO 16408:2015 n'est pas applicable aux autres formes de présentation (telles que sprays buccaux, mousses, poudres). Elle ne vise pas à décrire les aspects réglementaires, tels que les règles de prescription.
ISO 16408:2015 n'est pas applicable aux bains de bouche disponibles uniquement sur prescription médicale.
Zobozdravstvo - Izdelki za ustno nego - Sredstva za izpiranje ust (ISO/DIS 16408:2024)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Zobozdravstvo - Izdelki za ustno nego - Sredstva za izpiranje ust (ISO/DIS
16408:2024)
Dentistry - Oral care products - Oral rinses (ISO/DIS 16408:2024)
Zahnheilkunde - Mundhygieneprodukte - Mundspüllösungen und Mundwässer (ISO/DIS
16408:2024)
Médecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche (ISO/DIS
16408:2024)
Ta slovenski standard je istoveten z: prEN ISO 16408
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.
DRAFT
International
Standard
ISO/DIS 16408
ISO/TC 106/SC 7
Dentistry — Oral care products —
Secretariat: JISC
Oral rinses
Voting begins on:
Médecine bucco-dentaire — Produits d'hygiène bucco-dentaires
2024-04-01
— Bains de bouche
Voting terminates on:
ICS: 97.170 2024-06-24
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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BEING ACCEPTABLE FOR INDUSTRIAL,
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USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
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BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 16408:2024(en)
DRAFT
ISO/DIS 16408:2024(en)
International
Standard
ISO/DIS 16408
ISO/TC 106/SC 7
Dentistry — Oral care products —
Secretariat: JISC
Oral rinses
Voting begins on:
Médecine bucco-dentaire — Produits d'hygiène bucco-dentaires
— Bains de bouche
Voting terminates on:
ICS: 97.170
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
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Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 16408:2024(en)
ii
ISO/DIS 16408:2024(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 metals .2
5.4 Compatibility with oral tissues .2
5.5 Microbial contamination .2
5.6 Stability against ageing .3
5.7 Container and/or 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 Reagents and/or materials .4
7.4.2 Apparatus .4
7.4.3 Preparation of sample solution .4
7.4.4 Sample analysis .4
7.4.5 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 . 6
9.1 Manufacturer's instructions for use .6
9.2 Information on the primary container, and on the secondary container, if it exists .6
10 Packaging. 6
Bibliography . 7
iii
ISO/DIS 16408:2024(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,
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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 be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/ TC 106, Dentistry, Subcommittee SC 7, Oral care
products.
This third edition cancels and replaces the second edition (ISO 16408:2015), which has been technically
revised with the following changes:
— Updates according to ISO/IEC Directives for Clauses 1 and 3.
— Clause 2 were updated to include the latest version of ISO 8601-1 and to include ISO 19448.
— Clause 3 was updated to remove the definition of mouth spray as it is outside the scope of the document.
— Subclause 5.1 was clarified as ISO 28888 contains a screening method for non-fluoridated oral rinses.
— Subclause 5.2 was updated to lower the maximum fluoride per container and to reference new
subclause 7.4 and ISO 19448.
— Subclause 5.3 was updated to include a reference to USP <233> Elemental Impurities Procedures.
— Subclause 5.5 was updated to include references to USP <61>, USP <62>, and Ph.Eur. 2.6.12., include a
note regarding acceptance criteria, and to harmonize language with ISO 11609.
— Subclause 7.4 was added to include parts of removed Annex A.
— Clause 8 g) date of the test was added.
— Subclause 9.2 e) was updated to only include ingredients according to INCI.
— Subclause 9.2 g) was clarified regarding ethanol.
— Subclause 9.2 j) updated to include “and under adult supervision”.
— Annex A was removed as subclause 7.4 and ISO 19448 are now referenced for the determination of
fluoride.
iv
ISO/DIS 16408:2024(en)
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