SIST EN ISO 10873:2010
(Main)Dentistry - Denture adhesives (ISO 10873:2010)
Dentistry - Denture adhesives (ISO 10873:2010)
This International Standard classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This International Standard is applicable to denture adhesives for use by the public and excludes the dental lining materials prescribed or applied by dental professionals. This International Standard does not specify qualitative or quantitative requirements for freedom from
biological hazards. For assessing possible biological hazards, see ISO 7405 and ISO 10993-1.
Zahnheilkunde - Prothesenhaftmittel (ISO 10873:2010)
Diese Internationale Norm klassifiziert Prothesenhaftmittel, die von Trägern von herausnehmbarem Zahnersatz verwendet werden und legt deren Anforderungen und Prüfverfahren fest. Des weiteren werden Anforderungen an die Gebrauchsanweisung festgelegt. Diese Internationale Norm gilt für Prothesenhaftmittel, die durch den Konsumenten verwendet werden schließt dentale Unterfütterungswerkstoffe aus, die verordnet oder durch das zahnärztliche Fachpersonal angewendet werden.
Art dentaire - Adhésifs pour dentiers (ISO 10873:2010)
L'ISO 10873:2010 classe les adhésifs pour prothèses dentaires utilisés par les porteurs de prothèses amovibles et spécifie leurs exigences et méthodes d'essai. Elle spécifie également les exigences par rapport aux instructions devant être fournies relatives à l'utilisation de ces produits.
L'ISO 10873:2010 s'applique aux adhésifs pour prothèses dentaires amovibles destinés à être utilisés par le grand public et exclut les produits pour intrados de prothèse spécifiés ou appliqués par les professionnels dentaires.
Zobozdravstvo - Lepila za zobne proteze (ISO 10873:2010)
Ta mednarodni standard razvršča lepila za zobne proteze, ki jih uporabljajo uporabniki snemnih zobnih protez; prav tako določa zahteve, metode preskušanja in navodila, ki morajo biti zagotovljena za uporabo takšnih proizvodov. Ta mednarodni standard se uporablja za lepila za zobne proteze, ki jih uporablja prebivalstvo, in izključuje zobozdravstvene materiale za obloge, ki jih predpisujejo ali nanašajo zobozdravstveni strokovnjaki. Ta mednarodni standard ne določa kakovostnih ali količinskih zahtev za prepoved bioloških nevarnosti. Za oceno morebitnih bioloških tveganj glej ISO 7405 in ISO 10993-1.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10873:2010
01-november-2010
Zobozdravstvo - Lepila za zobne proteze (ISO 10873:2010)
Dentistry - Denture adhesives (ISO 10873:2010)
Zahnheilkunde - Prothesenhaftmittel (ISO 10873:2010)
Art dentaire - Adhésifs pour dentiers (ISO 10873:2010)
Ta slovenski standard je istoveten z: EN ISO 10873:2010
ICS:
11.060.01 Zobozdravstvo na splošno Dentistry in general
71.100.70 .R]PHWLND7RDOHWQL Cosmetics. Toiletries
SULSRPRþNL
SIST EN ISO 10873:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10873:2010
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SIST EN ISO 10873:2010
EUROPEAN STANDARD
EN ISO 10873
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2010
ICS 97.170
English Version
Dentistry - Denture adhesives (ISO 10873:2010)
Médecine bucco-dentaire - Adhésifs pour prothèses Zahnheilkunde - Prothesenhaftmittel (ISO 10873:2010)
dentaires (ISO 10873:2010)
This European Standard was approved by CEN on 11 September 2010.
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 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10873:2010: E
worldwide for CEN national Members.
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SIST EN ISO 10873:2010
EN ISO 10873:2010 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 10873:2010
EN ISO 10873:2010 (E)
Foreword
This document (EN ISO 10873:2010) 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 2011, and conflicting national standards shall be withdrawn at
the latest by March 2011.
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.
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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 10873:2010 has been approved by CEN as a EN ISO 10873:2010 without any modification.
3
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SIST EN ISO 10873:2010
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SIST EN ISO 10873:2010
INTERNATIONAL ISO
STANDARD 10873
First edition
2010-09-15
Dentistry — Denture adhesives
Médecine bucco-dentaire — Adhésifs pour prothèses dentaires
Reference number
ISO 10873:2010(E)
©
ISO 2010
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SIST EN ISO 10873:2010
ISO 10873:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 10873:2010
ISO 10873:2010(E)
Contents Page
Foreword .iv
1 Scope.1
2 Normative references.1
3 Terms and definitions .1
4 Classification .2
5 Requirements.2
5.1 General .2
5.2 Specific requirements for Type 1 adhesives .2
5.3 Specific requirements for Type 2 adhesives .2
6 Sampling.3
7 Test methods .3
7.1 Test conditions .3
7.2 pH value measurement .3
7.3 Determination of stability — Aging procedure.4
7.4 Test of washability (for Type 1 adhesives) .4
7.5 Adhesion strength test I (for Type 1 adhesives) .4
7.6 Adhesion strength test II (for Type 1 adhesives) .7
7.7 Adhesion strength test (for Type 2 adhesives) .8
7.8 Peeling test (for Type 2 adhesives) .10
7.9 Consistency test (for Type 2 adhesives).11
7.10 Assessment .12
8 Accompanying information.13
8.1 Information to be included in the manufacturer's instructions.13
8.2 Labelling on the package.14
Bibliography.15
© ISO 2010 – All rights reserved iii
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SIST EN ISO 10873:2010
ISO 10873:2010(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 10873 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 7, Oral care
products.
iv © ISO 2010 – All rights reserved
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SIST EN ISO 10873:2010
INTERNATIONAL STANDARD ISO 10873:2010(E)
Dentistry — Denture adhesives
1 Scope
This International Standard classifies denture adhesives used by wearers of removable dentures; it also
specifies requirements, test methods and instructions to be supplied for the use of such products.
This International Standard is applicable to denture adhesives for use by the public and excludes the dental
lining materials prescribed or applied by dental professionals.
This International Standard does not specify qualitative or quantitative requirements for freedom from
biological hazards. For assessing possible biological hazards, see ISO 7405 and ISO 10993-1.
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, Water for analytical laboratory use — Specification and test methods
ISO 7823-2, Plastics — Poly(methyl methacrylate) sheets — Types, dimensions and characteristics — Part 2
Extruded sheets
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
denture adhesives
dental product placed on the intaglio surface (fitting surface) of a removable denture to temporarily improve its
retention to soft supporting tissues
3.2
glue type
denture adhesive in powder, cream, sheet or tape form with water-soluble polymer as adhesive constituent
3.3
liner type
denture adhesive in non-aqueous paste form
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SIST EN ISO 10873:2010
ISO 10873:2010(E)
4 Classification
For the purposes of this International Standard, denture adhesives are categorized as one of the following
types:
a) Type 1: glue type:
⎯ Class 1: powder form;
⎯ Class 2: cream form;
⎯ Class 3: sheet or tape form.
b) Type 2: liner type.
5 Requirements
5.1 General
5.1.1 Biocompatibility
Particular attention should be given to assessing the effects on biocompatibility from the release of metallic
ions from the denture adhesive.
5.1.2 pH value
Denture adhesives shall have a pH value within the range of 4 to 10 when tested in accordance with 7.2.
5.1.3 Microbiology
Testing for microbiological contamination shall be carried out according to appropriate methods such as those
listed in References [11] to [14] or those specified in ISO 16212, ISO 18416, ISO 21148, ISO 21149,
ISO 21150, ISO 22717, ISO 22718 and ISO 29621.
5.1.4 Stability
The denture adhesive shall show no signs of deterioration which may affect compliance with this International
Standard after being subjected to one of the aging procedures specified in 7.3.
5.2 Specific requirements for Type 1 adhesives
5.2.1 Washability
There shall be no residual lump when tested in accordance with 7.4.
5.2.2 Strength of the adhesion to the prosthesis
Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.5 and 7.6.
5.3 Specific requirements for Type 2 adhesives
5.3.1 Adhesion strength
Adhesion strength shall not be less than 5 kPa when tested in accordance with 7.7.
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SIST EN ISO 10873:2010
ISO 10873:2010(E)
5.3.2 Peeling property
There shall be no residual lump when tested in accordance with 7.8.
5.3.3 Consistency
Consistency shall not be less than 15 mm when tested in accordance with 7.9.
6 Sampling
The sample shall be taken from one lot and shall be sufficient to complete all tests specified in Clause 7.
7 Test methods
7.1 Test conditions
All tests shall be conducted at a temperature of (23 ± 3) °C.
7.2 pH value measurement
7.2.1 Apparatus and material
7.2.1.1 pH meter, with a glass and comparison electrode assembly with an accuracy of ±0,02.
7.2.1.2 Glass container, of 500 ml capacity.
7.2.1.3 Circular filter paper, used to separate fine precipitates for chemical analysis.
7.2.2 Reagents
7.2.2.1 Propylene glycol, analytical grade.
7.2.2.2 Water, grade 3 in accordance with ISO 3696.
7.2.3 Procedure
7.2.3.1 Type 1 adhesives
7.2.3.1.1 Class 1 and Class 2
Take (1,0 ± 0,1) g of a Class 1 or Class 2 denture adhesive, add 5 g of propylene glycol (7.2.2.1) to disperse it,
and while stirring, add 300 ml of water (7.2.2.2) and mix them sufficiently. Insert the electrode of the pH meter
(7.2.1.1) into the dispersion and take the pH meter reading 3 min after the insertion.
7.2.3.1.2 Class 3
Take (1,0 ± 0,1) g of a Class 3 denture adhesive, add 300 ml of water and mix them sufficiently. Insert the
electrode of the pH meter and take the pH meter reading 3 min after the insertion.
7.2.3.2 Type 2
Take (1,0 ± 0,1) g of denture adhesive, spread evenly over a radius of approximately 40 mm on a piece of
filter paper (7.2.1.3). Place the filter paper in a glass container (7.2.1.2) and add 300 ml of water to it. After
immersing in water for 1 h, insert the electrode of the pH meter into water and take the pH meter reading
3 min after the insertion.
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SIST EN ISO 10873:2010
ISO 10873:2010(E)
7.3 Determination of stability — Aging procedure
Store the denture adhesives in their original containers at (40 ± 2) °C at (75 ± 5) % relative humidity for
3 months or at such conditions of time and temperature as will simulate storage at room temperature for
[15]
30 months .
7.4 Test of washability (for Type 1 adhesives)
7.4.1 Apparatus and materials
7.4.1.1 Water bath, capable of being maintained at a temperature of (37 ± 2) °C.
7.4.1.2 Poly(methyl methacrylate) plate (PMMA), approximately 50 mm × 50 mm, in accordance with
ISO 7823-2.
7.4.2 Reagent
7.4.2.1 Water, in accordance with 7.2.2.2.
7.4.3 Procedure
Apply the denture adhesive on the PMMA plate (7.4.1.2) evenly following the manufacturer's instructions for
use and immerse the plate in water for 1 h in the water bath (7.4.1.1) maintained at (37 ± 2) °C.
Wash the PMMA plate following the manufacturer's instructions for use and inspect the PMMA plate surface
with the naked eye, without magnification. Repeat the tests to obtain five test results.
7.5 Adhesion strength test I (for Type 1 adhesives)
7.5.1 General
Conduct the following adhesion strength test within 3 min after removal from the water bath.
7.5.2 Apparatus
7.5.2.1 Adhesion test instrument, having a sample stand, of capacity up to 10 N (for both frame and
load cell), with a cross-head speed up to 5 mm/min. See Figure 1.
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SIST EN ISO 10873:2010
ISO 10873:2010(E)
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Key 5
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2 pressure se
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