SIST EN ISO 10477:2005
(Main)Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004)
Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004)
ISO 10477:2004 classifies polymer-based dental crown and bridge materials and specifies their requirements. It also specifies the test methods to be used to determine compliance with these requirements.
ISO 10477:2004 is applicable to polymer-based dental crown and bridge materials for laboratory-fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion to the metal substructure without macromechanical retention such as beads or wires.
ISO 10477:2004 is not applicable to polymer-based materials that are used to make crowns, veneers or repairs in the operatory, nor does it cover the application of those materials to stress-bearing areas of posterior teeth.
Zahnheilkunde - Kronen- und Brückenkunststoffe (ISO 10477:2004)
In dieser Internationalen Norm werden zahnärztliche Kronen und Brückenkunststoffe in Typen eingeteilt und die Anforderungen festgelegt. Außerdem beschreibt sie die Prüfverfahren, die verwendet werden, um die Übereinstimmung mit diesen Anforderungen zu ermitteln.
Diese Internationale Norm gilt für zahnärztliche Kronen und Brückenkunststoffe, die im zahntechnischen Labor für definitive Verblendungen oder Frontzahnkronen hergestellt werden, und die wahlweise mit oder ohne Metallgerüst verwendet werden. Sie gilt auch für zahnärztliche Kronen und Brückenkunststoffe, für die der Hersteller eine Haftung an dem Metallgerüst ohne makromechanische Retention wie Perlen oder Drähte beansprucht.
Diese Internationale Norm gilt nicht für Kunststoffe, die während der Behandlung in der Zahnarztpraxis für die Herstellung von Kronen oder Verblendungen oder die für Reparaturen verwendet werden. Ebenso gilt sie nicht für Kunststoffe, die Kaukräften im Seitenzahnbereich ausgesetzt sind.
Art dentaire - Produits a base de polymeres pour couronnes et ponts (ISO 10477:2004)
L'ISO 10477:2004 établit une classification des produits à base de polymères pour couronnes et ponts, et spécifie les exigences qui leur sont applicables. Elle spécifie également les méthodes d'essai à utiliser en vue de la détermination de leur conformité à ces exigences.
L'ISO 10477:2004 est applicable aux produits à base de polymères pour couronnes et ponts pour facettes permanentes ou couronnes antérieures fabriquées en laboratoire, susceptibles ou non d'être fixées à une infrastructure métallique. Elle s'applique également aux produits à base de polymères pour couronnes et ponts pour lesquels le fabricant revendique une adhérence à l'infrastructure métallique sans rétention macromécanique, telle que les billes ou les fils.
L'ISO 10477:2004 n'est pas applicable aux produits à base de polymères utilisés pour fabriquer des couronnes, des facettes ou en vue des réparations au cabinet. Elle ne traite pas non plus des produits destinés à être appliqués aux zones des dents postérieures soumises à des contraintes de compression.
Zobozdravstvo – Polimerni materiali za prevleke in mostičke (ISO 10477:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10477:2005
01-marec-2005
1DGRPHãþD
SIST EN ISO 10477:2000
SIST EN ISO 10477:2000/A1:2000
=RER]GUDYVWYR±3ROLPHUQLPDWHULDOL]DSUHYOHNHLQPRVWLþNH ,62
Dentistry - Polymer-based crown and bridge materials (ISO 10477:2004)
Zahnheilkunde - Kronen- und Brückenkunststoffe (ISO 10477:2004)
Art dentaire - Produits a base de polymeres pour couronnes et ponts (ISO 10477:2004)
Ta slovenski standard je istoveten z: EN ISO 10477:2004
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 10477:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10477:2005
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SIST EN ISO 10477:2005
EUROPEAN STANDARD
EN ISO 10477
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2004
ICS 11.060.10 Supersedes EN ISO 10477:1996
English version
Dentistry - Polymer-based crown and bridge materials (ISO
10477:2004)
Art dentaire - Produits à base de polymères pour Zahnheilkunde - Kronen- und Brückenkunststoffe (ISO
couronnes et ponts (ISO 10477:2004) 10477:2004)
This European Standard was approved by CEN on 10 September 2004.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10477:2004: E
worldwide for CEN national Members.
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SIST EN ISO 10477:2005
EN ISO 10477:2004 (E)
Foreword
This document (EN ISO 10477:2004) 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 April 2005, and conflicting national
standards shall be withdrawn at the latest by April 2005.
This document supersedes EN ISO 10477:1996.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 10477:2004 has been approved by CEN as EN ISO 10477:2004 without any
modifications.
2
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SIST EN ISO 10477:2005
INTERNATIONAL ISO
STANDARD 10477
Second edition
2004-10-01
Dentistry — Polymer-based crown and
bridge materials
Art dentaire — Produits à base de polymères pour couronnes et ponts
Reference number
ISO 10477:2004(E)
©
ISO 2004
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SIST EN ISO 10477:2005
ISO 10477:2004(E)
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ii © ISO 2004 – All rights reserved
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SIST EN ISO 10477:2005
ISO 10477:2004(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 Biocompatibility . 2
5.2 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials . 2
5.3 Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials . 3
5.4 Surface finish . 3
5.5 Flexural strength . 3
5.6 Bond strength. 4
5.7 Water sorption. 4
5.8 Solubility . 4
5.9 Shade consistency. 4
5.10 Colour stability . 4
6 Sampling . 4
6.1 For all tests . 4
6.2 For test of shade consistency . 4
6.3 For test of colour stability. 5
7 Test methods. 5
7.1 General. 5
7.2 Visual inspection. 5
7.3 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials . 5
7.4 Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials . 7
7.5 Surface finish . 7
7.6 Flexural strength . 8
7.7 Bond strength. 11
7.8 Water sorption and solubility . 13
7.9 Shade consistency and colour stability . 16
8 Packaging and labelling . 17
8.2 Labelling. 18
9 Manufacturer's instructions and information for the user. 19
9.1 Instructions for use. 19
9.2 Shade guide. 20
Bibliography . 21
© ISO 2004 – All rights reserved iii
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SIST EN ISO 10477:2005
ISO 10477:2004(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 10477 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic
materials.
This second edition cancels and replaces the first edition (ISO 10477:1992), which has been technically
revised. It also incorporates the amendment ISO 10477:1992/Amd.1:1998.
The following changes were made:
a) addition of a bonding test;
b) addition of a table for the test protocol and two tables of results.
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SIST EN ISO 10477:2005
ISO 10477:2004(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
International Standard. Assessment of possible biological hazards is covered in ISO 10993-1 and ISO 7405.
© ISO 2004 – All rights reserved v
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SIST EN ISO 10477:2005
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SIST EN ISO 10477:2005
INTERNATIONAL STANDARD ISO 10477:2004(E)
Dentistry — Polymer-based crown and bridge materials
1 Scope
This International Standard classifies polymer-based dental crown and bridge materials and specifies their
requirements. It also specifies the test methods to be used to determine compliance with these requirements.
This International Standard is applicable to polymer-based dental crown and bridge materials for laboratory-
fabricated permanent facings or anterior crowns that may or may not be attached to a metal substructure. It
also applies to polymer-based dental crown and bridge materials for which the manufacturer claims adhesion
to the metal substructure without macromechanical retention such as beads or wires.
This International Standard is not applicable to polymer-based materials that are used to make crowns,
veneers or repairs in the operatory, nor does it cover the application of those materials to stress-bearing areas
of posterior teeth.
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 1562, Dentistry — Casting gold alloys
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7491, Dental materials — Determination of colour stability
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
ISO 8891, Dental casting alloys with noble metal content of at least 25 % but less than 75 %
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
polymer-based crown and bridge material
composition of powders and liquids or pastes that may contain monomers, inorganic and/or polymeric fillers
and that, when polymerized, is suitable for its intended use as permanent dental facings or anterior crowns
NOTE Polymerization is effected by mixing initiator(s) and activator(s) (“self-curing” materials) and/or by external
energy activation [by heat (“heat-curing” materials), photoactivated materials, by visible light (“light-curing” materials)
and/or by UV radiation].
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SIST EN ISO 10477:2005
ISO 10477:2004(E)
3.2
dentine resin
pigmented and slightly translucent polymer-based crown and bridge material that simulates the natural
appearance of dentine
3.3
enamel resin
translucent and slightly pigmented polymer-based crown and bridge material that is packed in a layer over the
dentine resin and that simulates the natural appearance of enamel
3.4
cervical resin
intensely pigmented and slightly translucent polymer-based crown and bridge material with a colour that
simulates the natural appearance of dentine of the cervical region of the tooth
3.5
opaque resin
intensely pigmented polymer-based crown and bridge material for masking the underlying metal substructure
4 Classification
The polymer-based crown and bridge materials described in this International Standard shall be classified
according to their activation system for polymerization.
Type 1 polymer-based crown and bridge materials whose setting is effected by mixing initiator(s) and
activator(s) (“self-curing” materials);
Type 2 polymer-based crown and bridge materials whose setting is effected by the application of energy
from an external source (“external-energy-activated” materials), such as heat and/or light or UV radiation;
Class 1 polymer-based crown and bridge materials that do not contain a light or UV-sensitive
initiator;
Class 2 polymer-based crown and bridge materials that contain a light or UV-sensitive initiator;
Type 3 polymer-based crown and bridge materials whose setting is effected by mixing initiator(s) and
activator(s) and also by the application of energy from an external source (“dual-cure” materials).
5 Requirements
5.1 Biocompatibility
See the Introduction for guidance on biocompatibility.
5.2 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials
The polymer-based crown and bridge materials Type 2, Class 2 shall remain physically homogeneous when
exposed to ambient light (see Table 1).
Testing shall be carried out in accordance with 7.3.
NOTE For Type 1, Type 2, Class 1 and Type 3 materials, no requirement is specified.
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SIST EN ISO 10477:2005
ISO 10477:2004(E)
Table 1 — Test protocol
Type 2
Subclause Property Type 1 Type 3
Class 1 Class 2
5.2 Sensitivity to ambient light — — + —
a
5.3 Depth of cure — — + —
Surface finish,
a a a a
5.4, 5.5 + + + +
flexural strength
5.6 Bond strength + + + +
Water sorption, solubility,
a a a a
5.7 to 5.10 shade consistency, + + + +
colour stability
+ carry out test;
— do not test.
a
If the material is opaque resin, do not test.
5.3 Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials
For Type 2, Class 2 polymer-based crown and bridge materials, the hardness of the bottom surface shall be
not less than 70 % of that of the top surface.
This requirement is not applicable to opaque resins (see Table 1).
Testing shall be carried out in accordance with 7.4.
NOTE For Type 1, Type 2, Class 1 and Type 3 no requirement is specified.
5.4 Surface finish
A test specimen polished in accordance with 7.5 shall have a glossy surface.
This requirement is not applicable to opaque resins (see Table 1).
Testing shall be carried out in accordance with 7.5.
5.5 Flexural strength
The flexural strength shall be at least 50 MPa (see Table 2).
This requirement is not applicable to opaque resins (see Table 1).
Testing shall be carried out in accordance with 7.6.
Table 2 — Physical and chemical requirements
Subclause Property Requirement
5.5 Flexural strength W 50 MPa
5.6.1 W 5 MPa
Bond strength
5.6.2 W 80 % of the value claimed
3
5.7 Water sorption u 40 µg/mm
3
5.8 Solubility u 7,5 µg/mm
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SIST EN ISO 10477:2005
ISO 10477:2004(E)
5.6 Bond strength
5.6.1 If the manufacturer recommends a special metal-bonding system without macromechanical retention,
the strength of bond to the metal used for the substructure shall be not less than 5 MPa (see Tables 1 and 2).
Testing shall be carried out in accordance with 7.7.
5.6.2 If the manufacturer claims a value higher than 5 MPa for the bond strength, then the bond strength
shall be not less than 80 % of the value claimed.
Testing shall be carried out in accordance with 7.7.
5.7 Water sorption
3
The water sorption of the cured polymer-based crown and bridge material shall be not more than 40 µg/mm
(see Table 2).
This requirement is not applicable to opaque resins (see Table 1).
Testing shall be carried out in accordance with 7.8.
5.8 Solubility
The solubility in water of the cured polymer-based crown and bridge material shall be not more than
3
7,5 µg/mm (see Table 2).
This requirement is not applicable to opaque resins (see Table 1).
Testing shall be carried out in accordance with 7.8.
5.9 Shade consistency
The colours of the cured polymer-based crown and bridge material from different batches shall show no more
than a slight difference.
This requirement is not applicable to opaque resins (see Table 1).
Testing shall be carried out in accordance with 7.9 and ISO 7491.
5.10 Colour stability
The polymer-based crown and bridge material shall show no more than a slight change in colour.
This requirement is not applicable to opaque resins (see Table 1).
Testing shall be carried out in accordance with 7.9 and ISO 7491.
6 Sampling
6.1 For all tests
The test sample shall consist of one or more retail packages prepared for retail sale of one randomly selected
shade from a single batch and contain sufficient (approximately 20 ml) material to carry out the specified tests,
plus an allowance for any necessary repetition of tests.
6.2 For test of shade consistency
The sample for the test of shade consistency (5.9 and 7.9) shall consist of the same shade as in 6.1 but of
another batch (approximately 1 ml).
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SIST EN ISO 10477:2005
ISO 10477:2004(E)
6.3 For test of colour stability
The sample for the test of colour stability (5.10 and 7.9) shall consist of two further randomly selected shades.
The whole sample shall represent one shade of enamel, dentine and cervical resin (approximately 1 ml each).
7 Test methods
7.1 General
7.1.1 Test conditions
Test specimens shall be prepared and tested at (23 ± 2) °C. The relative humidity shall be not less than 30 %.
7.1.2 Water
Unless otherwise specified, the water to be used shall conform to ISO 3696:1987, Grade 3.
7.1.3 Preparation of test specimens
For the preparation of Types 2 and 3 polymer-based crown and bridge materials, reference should be made to
the manufacturer's instructions [see 9.1 p) and q)] that state the external energy source or sources
recommended for the materials to be tested. Care shall be taken to ensure that the source is in a satisfactory
condition.
Mix or otherwise prepare the polymer-based crown and bridge material in accordance with the manufacturer's
instructions and the test conditions specified in 7.1.1.
Use only the quantity required to prepare one of the corresponding specimens.
If fully cured specimens are required for testing (7.5 to 7.9), it is important to ensure that the specimens are
homogeneous after removal from the mould. There should be no voids, clefts or air inclusions present by
visual inspection without magnification.
NOTE A separating medium which does not interfere with the setting reaction (e.g. 3 % solution of polyvinylstearyl
ether wax in hexane) may be used to facilitate removal of the specimen.
7.2 Visual inspection
Use visual inspection to determine compliance with Clauses 8 and 9. The colour comparison in 7.9 shall be
performed in accordance with ISO 7491.
7.3 Sensitivity to ambient light, Type 2, Class 2 polymer-based crown and bridge materials
7.3.1 Apparatus
7.3.1.1 Xenon lamp, or radiation source of equivalent performance (a suitable apparatus is described in
1)
ISO 7491) with colour-conversion filter inserted.
The colour-conversion filter shall be hardened glass of thickness 3 mm and shall have an internal
transmittance that matches within ± 10 % that shown in Figure 1.
7.3.1.2 Two glass microscope slides/plates.
7.3.1.3 Illuminance-measuring device, e.g. luxmeter, capable of measuring illuminance of
(8 000 ± 1 000) lx.
7.3.1.4 Adjustable table.
1) The KR 12 filter supplied by Schott Spezialglas GmbH, Vertrieb Filter, Hüttenstr. 1; D-31073 Grünenplan, Germany, is
an example of a suitable product available commercially. This information is given for the convenience of users of this
International Standard and does not constitute an endorsement by ISO of this product.
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SIST EN ISO 10477:2005
ISO 10477:2004(E)
7.3.1.5 Matt black cover for the luxmeter cell
NOTE This is intended to prevent reflections from the cell interfering with the observation of the specimen.
7.3.1.6 Timer, accurate to 1 s.
Key
X wavelength, nm
Y internal transmission
Figure 1 — Internal transmittance for colour-conversion filter (7.3.1.1)
7.3.2 Procedure
In a dark room, position the illuminance-measuring device cell (7.3.1.3) under the xenon lamp with the colour
conversion filter inserted (7.3.1.1) at such a height as to provide an illuminance of (8 000 ± 1 000) lx. [The
adjustable table (7.3 1.4) is required to do this efficiently.] Cover the cell with the matt black cover (7.3.1.5).
Place a spheroidal mass of approximately 30 mg of polymer-based crown and bridge material onto a glass
microscope slide (7.3.1.2), position the slide on top of the cell and expose it to the light for (60 ± 5) s. Remove
the slide with the sample from the irradiated area and immediately press the second microscope slide against
the polymer-based crown and bridge material with a shearing action to produce a thin layer.
Visually inspect the polymer-based crown and bridge material to see whether it is physically homogeneous.
NOTE During this test, if the polymer-based crown and bridge material has begun to set, clefts and voids will appear
in the specimen when the thin layer is being produced. It may aid the inspection to compare the test specimen with one
that has been produced in the absence of light.
Repeat the entire procedure twice, using a new sample of polymer-based crown and bridge material for each
test.
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SIST EN ISO 10477:2005
ISO 10477:2004(E)
7.3.3 Expression of results
Record the result of all three tests.
If, on visual inspection, the polymer-based crown and bridge material of all three samples remains physically
homogeneous, the polymer-based crown and bridge material complies with the requirement of 5.2. Otherwise
the polymer-based crown and bridge material does not comply with the requirement of 5.2.
7.4 Depth of cure, Type 2, Class 2 polymer-based crown and bridge materials
7.4.1 Apparatus
7.4.1.1 Split rings, such as shown in Figure 2, (15 ± 1) mm in diameter and (1 ± 0,1) mm high.
7.4.1.2 Transparent glass plate, measuring approximately 20 mm × 20 mm × 5 mm.
7.4.1.3 Polished metal plate, measuring approximately 20 mm × 20 mm × 5 mm.
7.4.1.4 Radiation source, as recommended by the manufacturer.
7.4.1.5 Hardness testing instrument, for HV 0,5.
7.4.2 Materials
7.4.2.1 White filter paper.
7.4.2.2 Colourless, clear, transparent polyester film, (50 ± 30) µm thick.
7.4.3 Procedure
Cover the polished metal plate (7.4.1.3) with a piece of white filter paper (7.4.2.1) followed by the polyester
film (7.4.2.2), and position the split ring (7.4.1.1) upon it. Prepare the polymer-based crown and bridge
material according to the manufacturer's instructions, and place it into the split ring to a slight excess. Cover
the polymer-based crown and bridge material and the split ring with a second piece of polyester film and the
glass plate (7.4.1.2), and extrude the excess material. Irradiate the test specimen in the split ring through the
polyester film, in accordance with the manufacturer's instructions. Remove the test specimen from the split
ring.
Prepare three specimens, and store them in water at (37 ± 1) °C for 24 h. Carry out the hardness test on the
upper and lower surfaces of the specimens three times in accordance with ISO 6507-1.
7.4.4 Expression of results
Express the hardness of each surface as the mean of the three values obtained for it.
All three specimens shall meet the requirement of 5.3. Otherwise the polymer-based crown and bridge
material does not comply with the requirement of 5.3.
7.5 Surface finish
Polish a test specimen prepared in accordance with the manufacturer's instructions. If no specific procedure is
given by the manufacturer, polish for not longer than 1 min with an 18- to 36-ply muslin wheel at a
circumferential speed of (650 ± 350) m/min and with precipitated calcium carbonate. Keep at least 10 mm
between the outer diameter of the wheel and the stitching or other reinforcement.
Thoroughly clean the specimen by rinsing with water, blot dry, and visually inspect the surface for compliance
with the requirement of 5.4.
NOTE A wheel with a diameter of 70 mm rotating at 1 500 r/min will have a circumferential speed of 330 m/min and a
100 mm diameter wheel rotating at 3 500 r/min will ha
...
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