SIST EN ISO 16408:2015

SLOVENSKI STANDARD
SIST EN ISO 16408:2015
01-december-2015
1DGRPHãþD
SIST EN ISO 16408:2004
Zobozdravstvo - Izdelki za ustno nego - Sredstva za izpiranje ust (ISO 16408:2015)
Dentistry - Oral care products - Oral rinses (ISO 16408:2015)
Zahnheilkunde - Mundhygieneprodukte - Mundspüllösungen und Mundwässer (ISO
16408:2015)
Médecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche (ISO
16408:2015)
Ta slovenski standard je istoveten z: EN ISO 16408:2015
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 16408:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16408:2015

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SIST EN ISO 16408:2015


EN ISO 16408
EUROPEAN STANDARD

NORME EUROPÉENNE

September 2015
EUROPÄISCHE NORM
ICS 97.170 Supersedes EN ISO 16408:2004
English Version

Dentistry - Oral care products - Oral rinses (ISO
16408:2015)
Médecine bucco-dentaire - Produits de soins bucco- Zahnheilkunde - Mundhygieneprodukte -
dentaire - Bains de bouche (ISO 16408:2015) Mundspüllösungen und Mundwässer (ISO
16408:2015)
This European Standard was approved by CEN on 10 July 2015.

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, 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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16408:2015 E
worldwide for CEN national Members.

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SIST EN ISO 16408:2015
EN ISO 16408:2015 (E)
Contents Page
European foreword . 3
2

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SIST EN ISO 16408:2015
EN ISO 16408:2015 (E)
European foreword
This document (EN ISO 16408:2015) 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 March 2016, and conflicting national standards shall
be withdrawn at the latest by March 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 16408:2004.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 16408:2015 has been approved by CEN as EN ISO 16408:2015 without any modification.
3

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SIST EN ISO 16408:2015

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SIST EN ISO 16408:2015
INTERNATIONAL ISO
STANDARD 16408
Second edition
2015-08-15
Dentistry — Oral care products — Oral
rinses
Médecine bucco-dentaire — Produits de soins bucco-dentaire —
Bains de bouche
Reference number
ISO 16408:2015(E)
©
ISO 2015

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SIST EN ISO 16408:2015
ISO 16408:2015(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, 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 2015 – All rights reserved

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SIST EN ISO 16408:2015
ISO 16408:2015(E)

Contents Page
Foreword .iv
Introduction .v
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 stability against ageing . 3
7.4.1 Test . 3
7.4.2 Compliance . 4
7.5 Pass/fail criteria . 4
8 Test report . 4
9 Accompanying information . 4
9.1 Manufacturer’s instructions for use . 4
9.2 Information on the primary container, and on the secondary container, if it exists . 4
10 Packaging . 5
Annex A (normative) Determination of fluoride in oral rinses containing ionic
fluoride compounds . 6
Bibliography . 9
© ISO 2015 – All rights reserved iii

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SIST EN ISO 16408:2015
ISO 16408:2015(E)

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).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 106, Dentistry, Subcommittee SC 7, Oral
care products.
This second edition cancels and replaces the first edition (ISO 16408:2004), which has been technically
revised with the following changes:
— “heavy metals” has been replaced by the term unintended heavy metals, which has been defined in 3.3;
— reference to ISO 28888 and corresponding requirement in 5.1 were added;
— ambient storage conditions of real time test for determination of stability against ageing (7.4.1) was
changed (23 ± 2) °C at (60 ± 15) % relative humidity;
— the bibliography was updated by including latest ISO/TC 217 standards.
iv © ISO 2015 – All rights reserved

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SIST EN ISO 16408:2015
ISO 16408:2015(E)

Introduction
Oral rinses are used for oral hygiene purposes intended to provide health and/or cosmetic benefits.
This International Standard specifies the chemical and physical properties of oral rinses. Common
labelling aspects are also specified in order to enhance international understanding and trade.
© ISO 2015 – All rights reserved v

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SIST EN ISO 16408:2015

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SIST EN ISO 16408:2015
INTERNATIONAL STANDARD ISO 16408:2015(E)
Dentistry — Oral care products — Oral rinses
1 Scope
This International Standard 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.
This International Standard 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.
This International Standard is not applicable to oral rinses available by prescription only.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information interchange — Representation of
dates and times
ISO 28888, Dentistry — Screening method for erosion potential of oral rinses on dental hard tissues
INCI, International Nomenclature for Cosmetic Ingredients
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
oral rinse
mouthrinse
mouthwash
liquid formulation used by the public for oral care purposes
[SOURCE: ISO 1942,
...