Dentistry - Oral care products - Oral rinses (ISO 16408:2015)

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 16408:2015)

Médecine bucco-dentaire - Produits d'hygiène bucco-dentaires - Bains de bouche (ISO 16408:2015)

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 16408:2015)

Ta mednarodni standard določa fizikalne in kemične zahteve ter preskusne metode za sredstva za izpiranje ust. Določa tudi informacije, ki spremljajo izdelek, kot na primer navodila za uporabo proizvajalca ter zahteve za označevanje in/ali etiketiranje. Ta mednarodni standard ne velja za druge sisteme za dovajanje (npr. ustna razpršila, pene, praški). Standard ne opisuje regulatornih vidikov, npr. načina predpisovanja. Ta mednarodni standard ne velja za sredstva za izpiranje ust, ki so na voljo samo prek recepta.

General Information

Status
Published
Publication Date
08-Sep-2015
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
09-Sep-2015
Completion Date
09-Sep-2015

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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

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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.

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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,
...

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