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

Status
Not Published
Publication Date
27-Oct-2025
Technical Committee
Current Stage
4020 - Submission to enquiry - Enquiry
Start Date
04-Apr-2024
Completion Date
04-Apr-2024

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SLOVENSKI STANDARD
oSIST prEN ISO 16408:2024
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
oSIST prEN ISO 16408:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 16408:2024

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oSIST prEN ISO 16408:2024
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.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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)
© ISO 2024

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oSIST prEN ISO 16408:2024
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.
COPYRIGHT PROTECTED DOCUMENT
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.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 16408:2024(en)
© ISO 2024
© ISO 2024 – All rights reserved
ii

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oSIST prEN ISO 16408:2024
ISO/DIS 16408:2024(en)
Contents Page
Foreword .iv
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions .
...

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