SIST EN ISO 16408:2004

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.

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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. It
also specifies the accompanying information such as 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 referenced documents are indispensable for the application of this document. 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 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
INCI, International Nomenclature of 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
3.2
mouthspray
liquid formulation in spray form for oral care purposes, not requiring dilution with water
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SIST EN ISO 16408:2004
ISO 16408:2004(E)
4 Classification
Oral rinses shall be classified according to their application by the user as follows:
 Type 1: ready-for-use solutions;
 Type 2: concentrated solutions for use after dilution with water;
 Type 3: solutions for use after mixing.
5 Requirements
5.1 pH value
Oral rinses shall have a pH value between 3,0 and 10,5. If the pH value of an oral rinse is below 5,5, it shall
pass a demineralization test or erosion test, or shall demonstrate safety by other appropriate methods.
Test the pH value in accordance with 7.1 and 7.3
NOTE 1 At the time of development of this International Standard, there was no evidence that oral rinses with pH
values between 5,5 and 10,5 promoted enamel erosion.
NOTE 2 At the time of development of this International Standard, several scientific test methods were available. It is
intended to include one internationally- accepted test method in the next revision of this International Standard.
5.2 Total fluoride concentration and maximum amount of fluoride
The total fluoride concentration of one container of oral rinse of Type 1 shall not exceed a mass fraction
of 0,15 %.
The maximum amount of ionic fluoride per single container shall not exceed 125 mg.
Fluoride-containing oral rinses shall be tested in accordance with Annex A or one of the procedures given in
[3]
ISO 11609:1995, Annex B , or other validated method of similar sensitivity and accuracy, for example
reference [4], [11] or [12].
5.3 Heavy metals
The maximum total concentration of heavy metals in oral rinses shall not exceed 20 mg/kg.
Test in accordance with a validated method, for example reference [5], [9] or [13], or other method of similar
sensitivity and accuracy.
5.4 Compatibility with oral tissues
Oral rinses shall not cause irritation or damage to the oral hard and/or soft tissue, when used in accordance
with the manufacturer’s recommendation for frequency and duration of use and experience with known side
effects.
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
International Standard, but it is recommended that reference be made to ISO 7405 and ISO 10993-1 when
assessing possible biological or toxicological hazards.
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SIST EN ISO 16408:2004
ISO 16408:2004(E)
5.5 Microbial contamination
The microbial contamination of oral rinses shall not exceed 100 colony-forming units per gram. Oral rinses
shall be free of pathogens.
Testing for microbial contamination shall be carried out according to a validated method, for example
reference [6], [7], [8] or [10].
5.6 Stability to ageing
Oral rinses shall show no signs of deterioration, such as agglomeration or change in clarity, after being
subjected to the determination of stability to ageing procedure specified in 7.4
NOTE Oral rinses that demonstrate stability through 30 months do not require an expiry date (expiration date) on the
product label [see 9.2 m)].
5.7 Container and/or dispensing system
The container and/or dispensing system shall neither contaminate nor permit contamination of the oral rinse
inside such that it will affect its compliance with the requirements of Clause 5 after being subjected to the
determination of stability to ageing described in 7.4.
5.8 Readily fermentable carbohydrates
Oral rinses shall not contain readily fermentable carbohydrates.
Compliance shall be established by the absence of such compounds in the complete formula, or by
performing tests in accordance with commonly used analytical methods.
6 Sampling
The oral rinses used for testing shall be representative of actual manufactured oral rinse and shall not be
altered in any way.
Eight containers of oral rinses from the same manufacturing tracking code (e.g. batch code, lot number) shall
be tested before the determination of stability to ageing (see 7.4).
Eight containers of oral rinses from the same manufacturing tracking code (e.g. batch code, lot number) shall
be tested after the determination of stability to ageing (see 7.4).
7 Test methods
7.1 General
All tests shall be performed before and after the test for stability to ageing (see 7.4).
7.2 Visual inspection
Before and after agitation, examine the oral rinse under a bright light with normal visual acuity without
magnification.
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