EN ISO 16408:2015
(Main)Dentistry - Oral care products - Oral rinses (ISO 16408:2015)
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
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Standards Content (Sample)
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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...
SLOVENSKI STANDARD
oSIST prEN ISO 16408:2014
01-julij-2014
Zobozdravstvo - Izdelki za ustno higieno - Sredstva za izpiranje ust (ISO/DIS
16408:2014)
Dentistry - Oral hygiene products - Oral rinses (ISO/DIS 16408:2014)
Zahnheilkunde - Mundhygieneprodukte - Mundspüllösungen und Mundwässer (ISO/DIS
16408:2014)
Médecine bucco-dentaire - Produits de soins bucco-dentaire - Bains de bouche (ISO/DIS
16408:2014)
Ta slovenski standard je istoveten z: prEN ISO 16408
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
oSIST prEN ISO 16408:2014 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 16408:2014
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oSIST prEN ISO 16408:2014
DRAFT INTERNATIONAL STANDARD
ISO/DIS 16408
ISO/TC 106/SC 7 Secretariat: JISC
Voting begins on: Voting terminates on:
2014-04-10 2014-09-10
Dentistry — Oral hygiene products — Oral rinses
Médecine bucco-dentaire — Produits de soins bucco-dentaire — Bains de bouche
[Revision of first edition (ISO 16408:2004)]
ICS: 97.170
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for
Standardization (ISO), and processed under the ISO lead mode of collaboration
as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member
bodies for a parallel five month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments
received, will be submitted to a parallel two-month approval vote in ISO and
THIS DOCUMENT IS A DRAFT CIRCULATED
formal vote in CEN.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
To expedite distribution, this document is circulated as received from the
IN ADDITION TO THEIR EVALUATION AS
committee secretariat. ISO Central Secretariat work of editing and text
BEING ACCEPTABLE FOR INDUSTRIAL,
composition will be undertaken at publication stage.
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 16408:2014(E)
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. ISO 2014
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oSIST prEN ISO 16408:2014
ISO/DIS 16408:2014(E)
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as
permitted under the applicable laws of the user’s country, neither this ISO draft nor any extract
from it may be reproduced, stored in a retrieval system or transmitted in any form or by any means,
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Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2014 – All rights reserved
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oSIST prEN ISO 16408:2014
ISO/DIS 16408
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 .
...
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