SIST EN ISO 10477:2000
(Main)Dentistry - Polymer based crown and bridge materials (ISO 10477:1992)
Dentistry - Polymer based crown and bridge materials (ISO 10477:1992)
Zahnheilkunde - Kronen- und Brückenkunststoffe (ISO 10477:1992)
Diese Internationale Norm gilt für Kronen- und Brückenkunststoffe, die im zahntechnischen Labor für definitieve Verblendungen oder Frontzahnkronen und die wahlweise mit oder ohne Metallunterkonstruktion verwendet werden. Ausgeschlossen sind Kunststoffe, die vom Zahnarzt bei der Behandlung für die Herstellung von Kronen oder Verblendungen oder für Reparaturen verwendet werden. Ebenso gilt sie nicht bei der Verwendung dieser Kunststoffe im den Kräften ausgesetzten Seitenzahnbereich.
Art dentaire - Produits a base de polymere pour couronnes et ponts (ISO 10477:1992)
Dentistry - Polymer based crown and bridge materials (ISO 10477:1992)
General Information
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Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10477:2000
01-januar-2000
Dentistry - Polymer based crown and bridge materials (ISO 10477:1992)
Dentistry - Polymer based crown and bridge materials (ISO 10477:1992)
Zahnheilkunde - Kronen- und Brückenkunststoffe (ISO 10477:1992)
Art dentaire - Produits a base de polymere pour couronnes et ponts (ISO 10477:1992)
Ta slovenski standard je istoveten z: EN ISO 10477:1996
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 10477:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10477:2000
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SIST EN ISO 10477:2000
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SIST EN ISO 10477:2000
IS0 10477:1992(E)
Introduction
Specific qualitative and quantitative requirements for freedom from bio-
logical hazards are not included in this International Standard but it is
recommended that, in assessing possible biological or toxicological
hazards, reference should be made to ISO/TR 74053984, Biological
evaluafion of dental maferials, or any more recent edition.
Although this International Standard does not require manufacturers to
declare details of the composition, attention is drawn to the fact that
some national or international authorities require details to be provided
to them.
. . .
Ill
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SIST EN ISO 10477:2000
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SIST EN ISO 10477:2000
INTERNATIONAL STANDARD
IS0 10477:1992(E)
Dentistry - Polymer-based crown and bridge materials
3 Definitions
1 Scope
For the purposes of this International Standard, the
This International Standard covers polymer-based
following definitions
crown and bridge materials for laboratory-fabricated
apply.
permanent facings or anterior crowns which may or
may not be attached to a metal substructure. It ex- 3.1 polymer-based crown and bridge material:
cludes polymer-based materials which are used by Composition of powders and liquids or pastes which
the dentist to make crowns or veneers, or for repairs
may contain monomer, polymeric and/or inorganic
at the operatory. Nor does it cover the application fillers. The crown and bridge materials polymerize
of those materials for stress-bearing areas of by heat, chemical activation or photoactivation to be
posterior teeth. suitable for the intended use as permanent facings
or anterior crowns.
This International Standard classifies polymer-based
crown and bridge materials and specifies the re-
3.2 dentine resin: Pigmented and slightly trans-
quirements: it also specifies the test methods to be
lucent polymer-based crown and bridge material
used to determine compliance with these require-
with a colour suitable to imitate the natural colour
ments.
of dentine.
3.3 enamel resin: Translucent and slightly
pigmented polymer-based crown and bridge ma-
terial suitable to imitate the natural colour of the
tooth enamel packed in a layer over the dentine re-
2 Normative references
sin.
The following standards contain provisions which,
3.4 cervical resin: Intensely pigmented and slightly
through reference in this text, constitute provisions
translucent polymer-based crown and bridge ma-
of this International Standard. At the time of publi-
terial with a colour suitable to imitate the natural
cation, the editions indicated were valid. All stan-
dentine colours of the cervical part of the tooth.
dards are subject to revision, and parties to
agreements based on this International Standard
Intensely pigmented polymer-
3.5 opaque resin:
are encouraged to investigate the possibility of ap-
based crown and bridge material suitable to mask
plying the most recent editions of the standards in-
the underlying metal substructure.
dicated below. Members of IEC and IS0 maintain
registers of currently valid International Standards.
IS0 3696:1987, Water for analytical laboratory use -
4 Classification
Specification and test methods.
The materials described in this International Stan-
IS0 6507-2:1983, Metallic materials - Hardness test
dard are classified according to their activation sys-
- Vickers test - Part 2: HV 0,2 to less than HV 5.
tem:
IS0 7491:1985, Dental materials - Determination of
Type 1 heat-activated material;
co/our stability of dental polymeric materials.
chemically activated (self-curing)
Type 2
material;
IS0 8601:1988, Data elements and interchange for-
Type 3 photoactivated- (light and/or UV
mats - Information interchange - Representation of
radiation-activated) material.
dates and times.
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SIST EN ISO 10477:2000
IS0 104773 992(E)
5.2.6 Solubility
5 Requirements
The solubility of the polymer-based crown and
bridge material shall not exceed 5 pg/mm3.
5.1 Components
Testing shall be carried out in accordance with 7.7.
When a component is supplied in the form of a
powder, it shall be free of extraneous matter. When
5.2.7 Colour and translucency
a component is supplied in the form of a liquid, it
shalt be free of deposits and/or sediment. The vis-
The colour and translucency of the polymer-based
cosity of the liquid shall not increase, and the liquid
crown and bridge material shall match closely the
shall not discolour. When a component is supplied
equivalent zone of the manufacturer’s shade guide.
in the form of a paste, it shall be free of extraneous
The colour and translucency of polymer-based
matter.
crown and bridge material from different batches
Testing shall be carried out in accordance with 7.2
shall show no more than a slight difference in col-
and 7.3.
our.
Testing shall be carried out in accordance with 7.2
52 . Polymerized crown and bridge material and 7.8.
5.2.8 Colour stability
52.1 Biocompatibility
The polymer-based crown and bridge material shall
See the Introduction for guidance on biocompati-
show no more than a slight change in colour.
bility.
Testing shall be carried out in accordance with 7.2
and 7.8.
52.2 Depth of cure
For types 1 and 2, no requirement is specified.
6 Sampling
For type 3, the hardness of the bottom surface shall
The test sample shall consist of one or more retail
not be less than 70 % of that of the top surface (i.e.
packages from the same batch with at least two
the surface towards the radiation) for 1 mm thick
containers of liquid as well as of two other batches
specimens of cervical resins and for 2 mm thick
of the same shade for the test of colour and
specimens of dentine resins and enamel resins.
translucency (5.2.7) and contain sufficient (approxi-
Testing shall be carried out in accordance with 7.4. mately 20 ml) material to carry out the specified
tests plus an allowance for any necessary repetition
of the tests.
5.2.3 Surface finish
A test spec men polished in accordance with 7.5
7 Test methods
shall have a highly polished surface.
7.1 General
be carried out in accordance with 7.2
Testing shal
and 7.5.
7.1 .I Test conditions
5.2.4 Flexural strength
The test specimens shall be prepared and tested at
(23 + 1) “C. The relative humidity shall be not less
The flexural strength, FBI in megapascals, shall be
than-30 %.
at least 50 MPa, and shall be not lower than the
value
7.1.2 Water
N = (flexural modulus x 0,0025) + 40 MPa
Unless otherwise specified, the water to be used
Testing shall be carried out in accordance with 7.6.
shall conform to IS0 3696, Grade 3.
7.1.3 Preparation of test specimens
5.2.5 Water absorption
Mix and process the polymer-based crown and
The water absorption of the polymer-based crown
bridge material in accordance with the manufac-
and bridge material sh all not exceed 32 pg/mm3.
turer’s instructions. Only use the quantity required
to prepare one of the corresponding specimens.
Testing shall be carried out in accordance with 7.7.
2
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SIST EN ISO 10477:2000
IS0 10477:1992(E)
Ensure that the apparatus for the polymerization of pared in accordance with the manufacturer’s in-
the polymer-based crown and bridge material is in structions, to a slight excess, into the split ring
satisfactory operating condition. avoiding air bubbles, cover it with the polyester film
and the glass plate, and carefully extrude excess
material. Irradiate the test specimen in the split ring
7.2 Visual inspection
in accordance with the manufacturer’s instructions
through the polyester film. Remove the test speci-
Use visual inspection to determine compliance with
men from the split ring. Prepare three specimens,
clauses 5.1, 5.2.3, 5.2.7, 5.2.8, 8, 9 and 10. The colour
store them in water at (37 + I) “C for 24 h and carry
comparison shall be performed in accordance with
out the hardness test according to IS0 6507-2 three
7.8.
times each on the upper and lower surface of each
specimen.
7.3 Components
7.4.3 Expression of results
7.3.1 Apparatus
Express the hardness of each su rface as the mean
Oven capable of maintaining a temperature of
of the three values ob ained for it
(60 zfi 2) “C.
The determinations for the three specimens shall
7.3.2 Procedure
meet the requirement of 5.2.2.
An original container of liquid shall be stored in the
7.5 Surface finish
dark for 24 h at (60 + 2) “C. A second container of
liquid shall be stored under the conditions rec-
Polish a test specimen prepared in accordance with
ommended by the manufacturer. Compare the vis-
the manufacturer’s instructions for not longer than
cosity and the colour of the two samples.
I min with a polishing agent used in dentistry and
with an 18 to 36 ply muslin wheel at a
7.4 Depth of cure: type 3 materials circumferential speed of (650 + 350) m/min. (A
wheel with a diameter of 70 mm rotating at
will have a circumferential speed of
1 500 min-’
7.4.1 Apparatus
and a 100 mm wheel rotating at
329 m/min
3 500 min-’ will have a circumferential speed of
7.4.1 .I Split rings such as shown in figure I,
1 010 m/min.) Keep at least IO mm between the
(1 & 0,l) mm or (2 k 0,l) mm high.
outer diameter of the wheel and the stitching or
other reinforcement. After polishing and thorough
7.4.1.2 Transparent glass plate of approximately
cleaning, visually inspect the surface.
20mmx20mmx5mm.
7.6 Flexural strength
7.4.1.3 Polished metal plate of approximately
20mmx20mmx5mm.
7.6.1 Apparatus
7.4.1.4 Colourless, clear, transparent, polyester
7.6.1.1 Split stainless steel mould coated with a
film, impermeable to oxygen, of (50 + 30) pm thick-
-
solution of
separating medium (e.g. 3 %
ness.
polyvinylstearyl ether wax in hexane), as shown in
figure 2, in an appropriate mounting device.
7.4.1.5 Radiation source as recommended by the
manufacturer.
7.6.1.2 Two glass or metal plates of approximately
30 mm x 30 mm x 2 mm coated with a separating
7.4.1.6 Hardness testing instrument for HV 0,2 for
medium, e.g. polyester film (for type 3 polymer-
measurements under load.
based crown and bridge materials of appropriate
transparency).
7.4.2 Procedure
7.6.1.3 Small screw clamp.
For the eck colour, use the split ri ng 1 mm high; for
all othe colours, use the sp lit ring 2 mm high.
7.6.1.4 Polymerization apparatus as recommended
by the manufacturer.
Cover the polished metal plate with a piece of the
polyester film and place the split ring on top. Pack
the polymer-based crown and bridge material pre- 7.6.1.5 Oven at (37 +- I) “C.
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SIST EN ISO 10477:2000
IS0 10477:1992(E)
Dimensions in millimetres
Split ring
Cover plates Retaining plate
or former
NOTE - The same mould may be used for the determination of depth of cure, absorption of water, solubility and coiour
stability; it may be made from metal, e.g. stainless steel alloy. The split ring has the following values for the height, h:
h = (1 + 0,l) mm for depth of cure and all other tests
-
h = (2 + 0,l) mm for depth of cure
-
Figure 1 - Preliminary mould for preparation of test specimens
7.6.2 Preparation of test specimens
7.6.1.6 Suitable test equipment with a constant
cross-head speed of (1 3r: 0,2) mm/min or at a load-
ing rate of (50 2 16) N/min and a bending apparatus
Cover one of the plates with a piece of polyester film
consisting of two parallel supports of 2 mm in diam-
and place the mould on top. Pack the polymer-based
eter in a distance of (20 + 0,l) mm and a third rod
crown and bridge material prepared in accordance
of 2 mm diameter in the-mid
...
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