EN ISO 16408:2004

Dentistry - Oral hygiene products - Oral rinses (ISO 16408:2004)

ISO 16408:2004 specifies physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as manufacturer's instructions for use, marking and/or labelling requirements.
ISO 16408:2004 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 16408:2004 is not applicable to oral rinses available by prescription only.

Zahnheilkunde - Mundhygieneprodukte - Mundspüllösungen und Mundwässer (ISO 16408:2004)

In dieser Internationalen Norm werden physikalische und chemische Anforderungen an und Prüfverfahren für Mundspüllösungen und Mundwässer festgelegt. Es werden auch Anforderungen an die Begleitinformationen wie Gebrauchsanweisung, Kennzeichnung und Etikettierung festgelegt.
Diese Internationale Norm ist nicht anwendbar auf andere Darreichungsformen (z. B. Mundsprays, Schaum, Puder). Es ist nicht beabsichtigt gesetzliche Aspekte zu beschreiben, z. B. Art der Verordnung.
Diese Internationale Norm ist nicht anwendbar auf Mundspüllösungen und Mundwässer, die verschreibungs-pflichtig sind.

Art dentaire - Produits d'hygiène buccale - Bains de bouche (ISO 16408:2004)

L'ISO 16408:2004 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.
L'ISO 16408:2004 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.
L'ISO 16408:2004 n'est pas applicable aux bains de bouche disponibles uniquement sur prescription médicale.

Zobozdravstvo – Izdelki za ustno higieno – Sredstva za izpiranje ust (ISO 16408:2004)

General Information

• Status: Withdrawn
• Publication Date: 14-Apr-2004
• Withdrawal Date: 08-Sep-2015
• ICS: 11.060.01 - Dentistry in general
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 09-Sep-2015
• Ref Project: SIST EN ISO 16408:2004 - Dentistry - Oral hygiene products - Oral rinses (ISO 16408:2004)

Relations

• Replaced By: EN ISO 16408:2015 - Dentistry - Oral care products - Oral rinses (ISO 16408:2015)
• Effective Date: 16-Sep-2015

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 16408:2004
01-november-2004
Zobozdravstvo – Izdelki za ustno higieno – Sredstva za izpiranje ust (ISO
16408:2004)
Dentistry - Oral hygiene products - Oral rinses (ISO 16408:2004)
Zahnheilkunde - Mundhygieneprodukte - Mundspüllösungen und Mundwässer (ISO
16408:2004)
Art dentaire - Produits d'hygiene buccale - Bains de bouche (ISO 16408:2004)
Ta slovenski standard je istoveten z: EN ISO 16408:2004
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 16408:2004 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 16408:2004

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SIST EN ISO 16408:2004

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SIST EN ISO 16408:2004


INTERNATIONAL ISO
STANDARD 16408
First edition
2004-04-15


Dentistry — Oral hygiene products —
Oral rinses
Art dentaire — Produits d'hygiène buccale — Bains de bouche





Reference number
ISO 16408:2004(E)
©
ISO 2004

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SIST EN ISO 16408:2004
ISO 16408:2004(E)
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©  ISO 2004
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 16408:2004
ISO 16408:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 16408 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral hygiene
products.
© ISO 2004 – All rights reserved iii

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SIST EN ISO 16408:2004
ISO 16408:2004(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.

iv © ISO 2004 – All rights reserved

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SIST EN ISO 16408:2004
INTERNATIONAL STANDARD ISO 16408:2004(E)

Dentistry — Oral hygiene products — Oral rinses
1 Scope
This International Standard specifies physical and chemical requirements and test methods for oral rinses.
...