STD=ISO 30477-ENGL 1992 = 4853903 0740529 92T

INTERNATIONAL IS0
STANDARD 10477
First edition
1992-12-15
AMENDMENT 1
1998-04-15

Dentistry - Polymer-based crown and

bridge materials
AMENDMENT 1

Art dentaire - Produits a base de polymère pour couronnes et ponts

AMENDEMENT 7

This material is reproducedfrom I S 0 documents under International Organization for

Standardization( S O )Copyright License number IHSllCC11996. Not for resale. No part
of these I S 0 documents may be reproduced in any form, electronic retrieval system
or otherwise, except as allowed in the copyright law of the country of use, or with the
prior written consent of IS0 (Case postale 56,1211 Geneva 20, Switzerland, Fax +41
22 734 10 79), IHS or the I S 0 Licensor's members.

Reference number
IS0 10477:1992/Amd.1:1998(E)
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STD-IS0 L0477-ENGL L992 4851903 0740530 641

I S 0 10477:1992/Amd.l:1998(E)

Foreword
I S 0 (the International Organization for Standardization) is a worldwide
federation of national standards bodies (IS0 member bodies). The work of
preparing International Standards is normally carried out through IS0
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. IS0
collaborates closely with the International Electrotechnical Commission
(IEC) on all matters of electrotechnical standardization.

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.

Amendment 1 to International Standard IS0 10477:1992 was prepared by

Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
P rosthoúonfic materials.

o I S 0 1998
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 CH-1211 Genève 20 Switzerland
Internet central@iso.ch
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland

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II
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 STD.ISO 10477-ENGL 3992 4853903 07110531 588
0 IS0 I S 0 10477:1992/Amd.l:1998(E)

Dentistry - Polymer-based crown and bridge materials

AMENDMENT 1

Page I

Clause 1 Scope
After the first paragraph, add the following paragraph.

"This International Standard applies to polymer-based crown and bridge materials for
which the manufacturer claims adhesion to the metal sub-frame without
macromechanical retention, such as beads or wires. It does not apply to denture base
polymer and its adhesion to metal alloys, or to ceramic and its bonding to alloys."

Clause 2 Normative references

Add the two following references:

IS0 1562:1993, Dental casting gold alloys.

IS0 8891 :1993, Dental casting alloys with noble metal content of 25 % up to but
not including 75 %.

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IS0 10477:1992/Amd.l :I998(E)

Page 2
Clause 5 Requirements
After subclause 5.2.8add the following subclause.

5.2.9 Bond strength

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5.2.9.1 If the manufacturer recommends a special bonding system without

macromechanical retention, the bond strength shall be not less than 5 MPa.
5.2.9.2 If the manufacturer claims a specific value for the bond strength, then the
bond strength shall be not less than 80 YOof this value.
Testing shall be carried out in accordance with 7.9.

Page 7
Clause 7 Test methods
After subclause 7.8.3add the following subclause.
7.9 Bond strength
7.9.1 Apparatus
7.9.1.1 Mould, of stainless steel with a slightly conical bore having a large diameter
of (5 I0,l)mm and a small diameter of (4,9f 0,l)mm, and (2,5f 0,05) mm high,
with sharp edges. The mould may be coated with a separating medium, e.g. a 3 Yo
solution of polyvinylstearyl ether wax in hexane.
7.9.1.2 Five metal plates, made of an alloy suitable for crown and bridge
technique with the dimensions of (20f 1) mm x (10f 1) mm x (2f 0,5) mm and made
by a conventional dental laboratory technique. The test surface shall be plane and the
finish as recommended by the manufacturer. If no specific brand is recommended by
the manufacturer, then the alloy or metal used shall conform with the alloys or product
groups specified in IS0 1562 or IS0 8891 where available.
7.9.1.3 Polyester film (as in 7.4.1.4).
7.9.1.4 Apparatus for thermocycling which automatically exposes the specimen
to 5 O00 cycles of 30 s to 35 s in water at (5 f 1) OC and 30 s to 35 s in water at
(55I1) OC.
7.9.1.5 Apparatus for testing shear bond strength (e.g. as shown in figure 3)
which allows the application of the force at a distance of (0,5 f 0,02) mm from the
surface of the metal plate (7.9.1.2).
7.9.1.6 Universal testing machine with a crosshead speed of (1 f 0,3)mm/min
and a system to record the force with an accuracy o f f 2 Yo.
NOTE Other instruments with a constant loading of (50 k 16) N/min may also be used.

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IS0 10477:1992/Amd.l:1998(E)

Dimensions in miltimetres

0.5t0.02

Key
A Fixation screw
B Fixation plate
C Plunger
D Stop pin

Figure 3 - Apparatus for testing shear bond strength

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7.9.2 Preparation of test specimens

Treat the metal plates (7.9.1.2) as recommended by the manufacturer of the bonding
system. Apply and cure the opaque resin to the bonding area as recommended by the
manufacturer of the crown and bridge material. Put the steel mould (7.9.1 . l ) onto the
opaque layer with the wider opening against the opaque layer. Press the crown and
bridge material into the mould and cover it with a polyester film (7.9.1.3). Cure the
crown and bridge material according to the manufacturer's instructions. Prepare five
specimens.
NOTE It is recommended that the steel mould (7.9.1.l)be fixed on the metal plate with the help of
a clamp so that it cannot move when the crown and bridge material is pressed into the mould.

7.9.3 Procedure
After curing the crown and bridge material, carefully remove the steel mould and store
the specimens dry at (23 f 2) "C for (24 f 2) h. Expose the specimen to 5 O00 thermal
cycles of 30 s to 35 s in water at (5 f 1) "C and 30 s to 35 s in water at (55 f 1) OC
(7.9.1.4).
Remove the specimen from the water (7.9.1.4) and measure two diameters of the
bonded crown and bridge material at right angles to each other. Calculate the
adhesive surface area, S, using the mean diameter.

3
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I S 0 10477:1992/Amd.l:1998(E) @ IS0

Adjust the specimen without drying in the apparatus (figure 3) for shear testing
(7.9.1 S).Take care that the metal plate contacts the baseplate of the apparatus. Put
the apparatus in the universal testing machine (7.9.1.6) and load the specimen with a
constant crosshead speed of (1 f 0,3) mm/min [or at (50 f 16) N/min] and record the
load Fat break.

7.9.4 Calculation and expression of results

Calculate the bond strength B, in megapascals, from the equation
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where
F is the load, in newtons, at break;
S is the bonded surface area, in square millimetres.

7.9.5 Interpretation of results

Report all values of the bond strength in megapascals, together with the type of alloy
used for the test.
If four of the five values are not less than 5 MPa, the crown and bridge material
complies with the requirement according to 5.2.9.1.
If three or more of the five values are less than 5 MPa, the crown and bridge material
does not comply with the requirement according to 5.2.9.1.
If only three of the five values are not less than 5 MPa, repeat the whole test. If all five
values are not less than 5 MPa on the second occasion, the crown and bridge material
complies with the requirement according to 5.2.9.1.
If the manufacturer has claimed a specific value for the bond strength then at least
four out of five, (or eight out of ten, where a second series is necessary), of the test
values shall be not less than 80 % of the claimed value, in order to comply with the
requirement according to 5.2.9.2.

Page 8

Clause 8 Manufacturer's instructions and shade guide

After 8.1 u) add the following items:

v) if the manufacturer claims adhesion between the polymer-based crown and bridge
material and the metal without macromechanical retention, then the method of use
and treatment of the metal shall be stated;

w) if the manufacturer claims a specific value for the bond strength, then the
measured bond strength shall not be less than the value claimed and shall comply
with the requirements in 5.2.9 when tested in accordance with 7.9.

4
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 I S 0 10477:1992/Amd.l:1998(E)

~ ~ ~~

ICs 11.060.1O
Descriptors: dentistry, dental materials, resins, classification, specifications, tests, determination, stability, colour, bonding strength.

Price based on 4 pages

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 I S 0 LO477 9 2 m 4853903 0522700 746 m

INTE R NATIO NA L IS0

STANDARD 10477
First edition
1992-12-15

Dentistry - Polymer-based crown and bridge

materials

Art dentaire - Produits à base de polymère pour couronnes et ponts

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Reference number
I S 0 10477:1992(E)

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IS0 10477 92 4851903 0522701 882 M

I S 0 10477:1992(E)

Foreword

I S 0 (the International Organization for Standardization) is a worldwide

federation of national standards bodies (IS0 member bodies). The work
of preparing International Standards is normally carried out through IS0
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, govern-
mental and non-governmental, in liaison with ISO, also take part in the
work. I S 0 collaborates closely with the International Electrotechnical
Commission (IEC) on ali matters of electrotechnical standardization.

Draft International Standards adopted by the technical committees are

circulated to the member bodies for voting. Publication as an Inter-
national Standard requires approval by at least 75% of the member
bodies casting a vote.

International Standard I S 0 10477 was prepared by Technical Committee

ISO/TC 106, Dentistry, Sub-Committee SC 2, Prosfhodontic materials.

0 I S 0 1992
All riahts reserved. No part of this publlcation may be reproduced or utilized in any form
or b y a n y means, electronic or mechanlcal, including photocopying and microfilm, without
permission in wrlting from the publisher.
International Organization for Standardization
Case Postale 56 CH-I211 Genève 20 Switzerland
Printed in Swltzeriand

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 IS0 10477 92 m 4851903 0522702 719 m

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 7405:1984, Biological
evaluation of dental materials, 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.
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 I S 0 LOLi77 92 m 4 8 5 3 9 0 3 0522703 655 ~~
m
~ ~

INTERNATIONAL STANDARD IS0 1047E1992(E)

Dentistry - Polymer-based crown and bridge materials

1 Scope 3 Definitions
This International Standard covers polymer-based For the purposes o this International tandard, the
crown and bridge materials for laboratory-fabricated following definitions 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 t o 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
2 Normative references tooth enamel packed in a layer over the dentine re-
sin.
The following standards contain provisions which,
through reference in this text, constitute provisions 3.4 cervical resin: Intensely pigmented and slightly
of this International Standard. At the time of publi- translucent polymer-based crown and bridge ma-
cation, the editions indicated were valid. All stan- terial with a colour suitable to imitate the natural
dards are subject to revision, and parties to dentine colours of the cervical part of the tooth.
agreements based on this International Standard
are encouraged to investigate the possibility of ap- 3.5 opaque resin: Lntensely pigmented polymer-
plying the most recent editions of the standards in- based crown and bridge material suitable to mask
dicated below. Members of IEC and I S 0 maintain the underlying metal substructure.
registers of currently valid International Standards.

I S 0 3696:1987, Water for analytical laboratory use - 4 Classification

Specification and test methods.
The materials described in this International Stan-
I S 0 6507-2:1983, Metallic materials - Hardness test dard are classified according to their activation sys-
- Vickers fest - Part 2: HV 0,2to less than HV 5. tem:

IS0 7491:1985, Dental materials - Determination of Type 1 heat-activated material;

colour stability of dental polymeric materials.
Type 2 chemically activated (self-curing)
material;
IC0 8601:1988, Data elements and interchange for-
mats - Information interchange - Representation of Type 3 photoactivated- (light and/or UV
dates and times. radiation-activated) material.

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 -
--.
IS0 LO477 9 2
IS0 10477:1992(E)
5 Requirements
5.1 Components
When a component is supplied in the form of a
powder, it shall be free of extraneous matter. When
a component is supplied in the form of a liauid, it
shall be free of deposits and/or sediment. The vis-
cosity of the liquid shall not increase, and the liquid
shall not discolour. When a component is supplied
in the form of a paste, it shall be free of extraneous
matter.
Testing shall be carried out in accordance with 7.2
and 7.3.
5.2 Polymerized crown and bridge material
5.2.1 Biocompatibility
See the Introduction for guidance on biocompati-
bility.
5.2.2 Depth of cure
For types 1 and 2, no requirement is specified.
For type 3, the hardness of the bottom surface shall
not be less than 70 YOof that of the top surface (¡.e.
the surface towards the radiation) for 1 mm thick
specimens of cervical resins and for 2 mm thick
specimens of dentine resins and enamel resins.
Testing shall be carried out in accordance with 7.4.
5.2.3 Surface finish
A test specimen polished in accordance with 7.5
shall have a highly polished surface.
Testing shall be carried out in accordance with 7.2
and 7.5.
5.2.4 Flexural strength
The flexural strength, ZB, in megapascals, shall be
at least 50 MPa, and shall be not lower than the
value
N = (flexural modulus x 0,0025)
Testing shall be carried out in accordance with 7.6.
5.2,5 Water absorption
The water absorption of the polymer-based crown
and bridge material shall not exceed 32 pg/mm3.
Testing shall be carried out in accordance with 7.7.
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4851903 0 5 2 2 7 0 4 571
5.2.6 Solubility
The solubility of the polymer-based c p w n and
bridge material shall not exceed 5 pg/mm .
Testing shall be carried out in accordance with 7.7.
5.2.7 Colour and translucency
The colour and translucency of the polymer-based
crown and bridge material shall match closely the
equivalent zone of the manufacturer's shade guide.
The colour and translucency of polymer-based
crown and bridge material from different batches
shall show no more than a slight difference in col-
our.
Testing shall be carried out in accordance with 7.2
and 7.8.
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5.2.8 Colour stability
The polymer-based crown and bridge material shall
show no more than a slight change in colour.
Testing shall be carried out in accordance with 7.2
and 7.8.
6 Sampling
The test sample shall consist of one or more retail
packages from the same batch with at least two
containers of liquid as well as of two other batches
of the same shade for the test of colour and
translucency (5.2.7) and contain sufficient (approxi-
mately 20 ml) material to carry out the specified
tests plus an allowance for any necessary repetition
of the tests.
7 Test methods
7.1 General
7.1.1 Test conditions
The test specimens shall be prepared and tested at
(23 f 1) OC. The relative humidity shall be not less
than 30 %.
7,1.2 Water
+ 40 MPa
Unless otherwise specified, the water to be used
shall conform to IS0 3696, Grade 3.
7.1.3 Preparation of test specimens
Mix and process the polymer-based crown and
bridge material in accordance with the manufac-
turer's instructions. Only use the quantity required
to prepare one of the corresponding specimens.
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 I S 0 10477 92 m 4853903 0522705 428 m
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
7.2 Visual inspection material. Irradiate the test specimen in the split ring
in accordance with the manufacturer's instructions
Use visual inspection to determine compliance with through the polyester film. Remove the test speci-
clauses 5.1, 5.2.3, 5.2.7, 5.2.8, 8, 9 and I O . The colour men from the split ring. Prepare three specimens,
comparison shall be performed in accordance with store them in water at (37 f 1) "C for 24 h and carry
7.8. out the hardness test according to I S 0 6507-2 three
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 surface as the mean
Oven capable of maintaining a temperature of of the three values obtained for it.
(60 -1: 2) OC.
The determinations for the three specimens shall
7.3.2 Procedure meet the requirement of 5.2.2.
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An original container of liquid shall be stored in the 7.5 Surface finish

dark for 24 h at (60 f 2) OC. 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. 1 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 f 350) m/min. (A
wheel wit! a diameter of 70 mm rotating at
7.4.1 Apparatus 1 500 min- will have a circumferential speed of
,
329 m/min and a 100 mm wheel rotating at
7.4.1.1 Split rings such as shown in figurel, 3 500 min- will have a circumferential speed of
(1 rt: 0,l) mm or (2 f 0,l) mm high. I 0 1 0 m/min.) Keep at least 10 mm between the
outer diameter of the wheel and the stitching or
7.4.1.2 Transparent glass plate of approximately other reinforcement. After polishing and thorough
20 mm x 20 mm x 5 mm. cleaning, visually inspect the surface.

7.4.1.3 Polished metal plate of approximately 7.6 Flexural strength

20 mm x 2 0 mm x 5 mm.
7.6.1 Apparatus
7,4.1,4 Colourless, clear, transparent, polyester
film, impermeable to oxygen, of (50 f 30) pm thick- 7.6.1.1 Split stainless steel mould coated with a
ness. separating medium (e.g. 3 YO solution of
polyvinylstearyl ether wax in hexane), as shown in
7,4.1,5 Radiation source as recommended by the figure 2, in an appropriate mounting device.
manufacturer.
7.6.1.2 Two glass or metal plates of approximately
7,4.2.6 Hardness testing instrument for HV 0,2 for 30 mm x 30 mm x 2 mm coated with a separating
measurements under load. medium, e.g. polyester film (for type 3 polymer-
based crown and bridge materials of appropriate
7.4.2 Procedure transparency) .

For the neck colour, use the split ring 1 mm high; for 7.6.1.3 Small screw clamp.
all other colours, use the split ring 2 mm high.
7.6.1.4 Polymerization apparatus as recommended
Cover the polished metal plate with a piece o f the by the manufacturer.
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 f 1) OC.

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 I S 0 10477:1992( E)
Cover plates
NOTE - The same mould may be used for the determination of depth of cure, absorption of water, solubility and colour
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 k 0,l) mm for depth of cure and ail other tests
h = (2 f 0 , l ) mm for depth of cure
Figure 1
7.6.1.6 Suitable test equipment with a constant
*
cross-head speed of (1 f 0,2)mm/min or at a load-
ing rate of (50 16) N/min and a bending apparatus
consisting of two parallel supports of 2 mm in diam-
eter in a distance of (20 f 0,l) mm and a third rod
of 2 mm diameter in the middle between the two
supports for loading the specimen centrally.
7.6.1.7 Micrometer with an accuracy of 0,Ol mm.
4
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Dimensions in millimetres
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SpUt ring
Retainlno plate
or former
- Preliminary mould for preparation of test specimens
7.6.2 Preparation of test specimens
Cover one of the plates with a piece of polyester film
and place the mould on top. Pack the polymer-based
crown and bridge material prepared in accordance
with the manufacturer's instructioiis, to a slight ex-
cess, into the mould avoiding air bubbles, cover with
the polyester film and the other plate, and carefully
extrude the excess material with the screw clamp.
Polymerize the polymer-based crown and bridge
material in accordance with the manufacturer's in-
structions. Separate the test specimen from the
Not for Resale
 IS0 LO477 92 m 4853903 O522707 2TO m
IS0 10477:1992(E)

Dimensions in milllmetres

Figure 2 - Split mould for preparation of test specimens for the flexural test, made from stainless steel
mould, remove the flash and store in water at
(37 f 1) "C. Prepare five test specimens.

7.6.3 Procedure where

Ff is the load, in newtons, at a con-

At 24 h after the start of the preparation of the test venient point in the straight line por-
specimens, measure the breadth and the height of tion of the trace;
the test specimens to an accuracy of 0,Ol mm. Sub-
sequently apply a load at a cross-head speed of f is the deflection of the test specimen
(1 & 0,3)mm/min or at a loading rate of in millimetres at load F I ;
(50 & 16) N/min until the specimen fractures.
I, b and h are as defined above.

7.6.4 Calculation and expression of results NOTE I For greater accuracy the straight line may be
extended. Calculate the result for each specimen.
Calculate the flexural strength, oB,in megapascals,
from the equation
7.6.5 Interpretation of results
3Fl
an = -
2úh2 If at least four of the results are not less than
50 MPa, the polymer-based crown and bridge ma-
where terial meets the requirement. If less than three of the
results are not less than 50 MPa, the material does
F is the maximum applied load in newtons; not meet the requirement. If three of the results are
not less than 50 MPa, repeat the whole test. Only if
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1 is the supporting width, in millimetres, all results are not less than 50 MPa on the second
¡.e. 20 mm; occasion does the material meet the requirement. If
b is the breadth of the test specimen, in four or five out of five specimens or, where a second
millimetres; series was necessary, eight out of ten specimens
were not less than 50 MPa, discard the failed results
h is the height of the test specimen, in and calculate the mean flexural strength, ¿fe, of the
millimetres. successful specimens to three significant figures.

Using the values for flexural strength, calculate the Calculate the flexural modulus, in megapascals of
flexural modulus, E, in megapascals, from the each of the su_ccessful specimens and determine the
equation mean value, E , to three significant figures; using this

5
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I S 0 JOY77 7 2 m Y851703 0 5 2 2 7 0 8 1 3 7
I S 0 10477:1992(E)
mean value, calculate the value, N , in megapascals,
using the following equation
N = ( E x 0,0025) + 40 MPa
The material meets the requirement if ÜB> N .
7.7 Water absorption and solubility
7.7.1 Apparatus
7.7.1.1 Split ring such as shown
(1 f 0,l) mm high.
7.7.1.2 Glass plates as in 7.4.1.2.
7.7.1.3 Polyester film as in 7.4.1.4.
7.7.1.4 Screw clamp.
7.7.1.5 Polymerization apparatus as recommended
by the manufacturer.
7.7.1.6 Oven as in 7.6.1.5.
7,7.1.7 Two desiccators containing silica gel freshly
dried for 5 h at 130 OC. Replace the silica gel with
freshly dried gel after each weighing sequence.
7.7.1.8 Analytical balance with an accuracy of
+
- 0,l mg.
7.7.1.9 White filter paper.
7.7.1. I O Aluminium oxide grinding powder with
grain size approximately 0,3 pm.
7.7.1.11 Water conforming to I S 0 3696, Grade 2.
7.7.2 Preparation of test specimens
For type 3 polymer-based crown and bridge ma-
terials, place a piece of the filter paper on one of the
glass plates. Thereon, for all types, place a piece of
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the polyester film and the split ring on top. Pack the
polymer-based crown and bridge material prepared
in accordance with the manufacturer's instructions,
to a slight excess, into the split ring avoiding air
bubbles, cover with the polyester film and the other
glass plate and carefully extrude the excess ma-
terial with the screw clamp. Polymerize the
polymer-based crown and bridge material in ac-
cordance with the manufacturer's instructions. Sep-
arate the test specimen from the split ring, wet-grind
it on both sides and polish it on felt to a high gloss
with aluminium oxide suspended in water and to a
thickness of (1,O f 0,2) mm. Measure the diameter
and the thickness in the centre and at four points at
the periphery of the test specimen to an accuracy
o f f 0,Ol mm. Calculate the volume, V , from the di-
6
Copyright International Organization for Standardization
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No reproduction or networking permitted without license from IHS
.__ ____
m
ameter and the mean of the five thickness meas-
urements. Prepare five test specimens.
7.7.3 Procedure
Store the polished test specimens in a desiccator
at (37 f 1)'"C. After 23 h store the test specimens in
a second desiccator for 1 h at (23 f 1) "C. Then
weigh each test specimen to an accuracy of
f 0,2 mg. Continue this drying procedure until the
loss of mass of every test specimen remains less
in figure 1, than 0,2 mg within 24 h (mass m,).Store the test
specimens in 20 ml water at (37 f 1) "C for 7 days.
Separately, remove the test specimens, wash with
water and dab with blotting paper until free from
visible moisture. Then wave each specimen in the
air for 15 s and weigh 1 min after removal from the
water (mass e).
After weighing recondition the test
specimens in the desiccator to a constant mass until
the loss is less than 0,2 mg within 7 days using the
cycle described above (mass &).
7.7.4 Calculation and expression of results
7.7.4.1 Water absorption
Calculate the values for water absorption, in micro-
grams per cubic for each of the five
specimens to the nearest 0,l pg/mm3 from the
equation
water absorption =
m2 - m,
V
If at least four of the values are not more than
32 pg/mm3, the polymer-based crown and bridge
material meets the requirement. If less tgan three
of the values are not more than 32 unlmm , the ma-
terial does not meet the requiremenc'lf three of the
values are not more than 32 pg/mm3, repeat the
whole test. Only if all the values are not more than
32pg/mm3 on the second occasion does the ma-
terial meet the requirement.
7.7.4.2 Solubility
Calculate the values for solubility, in micrograms
per cubic millimetre, for tach of the five specimens
to the nearest 0,l pg/mm from the equation
If at lea$ four of the values are not more than
5 pg/mm , the polymer-based crown and bridge
material meets the requirement. If less than three
of the values are not more than 5 pg/mm3, the ma-
terial does not meet the requirement. If three of the
values are not more than 5 pg/mm3, repeat the
whole te$ Only if all the values are not more than
5 pg/mm on the second occasion does the material
meet the requirement.
Not for Resale
 IS0 LO477 9 2 M 4853903 0522709 073
7.8 Colour, translucency and colour stability
7.8.1 Apparatus
7.8.1.1 Split ring as shown
(1 0,l) mm high.
7.8.1.2 Glass plates as in 7.4.1.2.
7.8.1,3 Polyester film as in 7.4.1.4.
7.8.1.4 Screw clamp.
7.8,1.5 Polymerization apparatus as recommended
by the manufacturer.
7.8.1.6 Oven as in 7.6.1.5.
7.8.1.7 Radiation apparatus in accordance with
I S 0 7491.
7,8.2 Preparation of test specimens
Prepare five test specimens in accordance with the
requirement in 5.2.7 (three out of one batch and one
specimen each out of the other two batches) and in
accordance with the procedure in 7.7.2, and store
them at room temperature in the dark.
7.8.3 Procedure
For the test of colour stability, irradiate two speci-
mens out of the same batch for 24 h in accordance
with I S 0 7491. After exposure remove the metal foil
and transfer these two specimens to the oven at
(37 I 1) " C and store them in the dark for six days.
Compare the colour, the translucency and the colour
stability for all five test specimens in accordance
with IS0 7491. All test specimens shall show no
more than a slight change in colour. All five test
specimens shall match closely the manufacturer's
shade guide.
8 Manufacturer's instructions and shade
guide
8.1 Instructions
Instructions for use, together with the description of
the product, shall be provided by the manufacturer
for the user and accompany each set or package of
polymer-based crown and bridge material with at
least the following information:
a) the name and the address of the manufacturer
and/or di st ributor;
b) the trade-name of the polymer-based crown and
bridge material;
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Copyright International Organization for Standardization
Provided by IHS under license with ISO
No reproduction or networking permitted without license from IHS
I S 0 10477:1992(E)
c) the method of polymerization, e.g. pressure-,
heat-, self-, light-, and/or UV radiation-curing;
d) the range of application;
in figurel,
e) if compliance with this International Standard is
claimed by the manufacturer, a statement that
I S 0 10477 does not cover the application of these
materials for stress-bearing areas in posterior
teeth;
9 the description of the components including the
principal organic constituents and the filler com-
position;
g) for inorganic fillers, the range of the particle size,
the particle size distribution and the volume ra-
tio:
h) the method of preparation of the metal structure:
i) the investing procedure;
j) the method of preparing and proportioning the
components, selecting the shade with the manu-
facturer's shade guide and the procedure for
mixing, and the temperature, humidity and am-
bient light conditions that are likely to affect the
polymer-based crown and bridge material ad-
versely and all precautions to be taken;
k) any special precautions regarding the manipu-
lation of the polymer-based crown and bridge
material including, if appropriate, the maximum
proportion of tinters and blenders which may be
used without detriment to the physical proper-
ties;
I) the procedure for the application of the polymer-
based crown and bridge material;
m) the working time;
n) for type 1 polymer-based crown and bridge ma-
terials, the polymerization procedure and time;
o) for type 2 polymer-based crown and bridge ma-
terials, the setting time;
p) for type 3 polymer-based crown and bridge ma-
terials, the radiation source, radiation time and
depth of cure;
q) the recommended procedures for finishing and
polishing;
r) information on limitations and side effects;
s ) the recommended conditions for storage (e.g.
refrigeration) of the components and the shelf-
life under those conditions;
7
Not for Resale
 I S 0 10477:1992(E)
t) the types of presentation and package sizes;
u) the date of publication of these manufacturer’s
instructions .
8.2 Shade guide
The manufacturer shall provide a shade guide or
recommend a suitable one.
9 Packaging
The components of the polymer-based crown and
bridge material shall be supplied in such containers
and in such quantities that the contents are ad-
equately protected and the quality of the polymer-
based crown and bridge material is not adversely
altered during the shelf-life stated by the manufac-
turer [see 10.1 h) and 10.2 g)].
NOTE 2 The containers are the immediate wrapping of
the polymer-based crown and bridge material. An outer
pack may also be used to present the containers or a set
as a single unit.
10 Marking
10.1 Outer pack
Each pack shall be marked with at least the follow-
ing information:
a) the name and address of the manufacturer;
b) the trade-name of the polymer-based crown and
bridge material;
c) the method of polymerization, e.g. pressure-,
heat-, self-, light- and/or UV radiation-curing;
d) the shade, or shades or description which can
be related to the manufacturer’s shade guide;
8
Copyright International Organization for Standardization
Provided by IHS under license with ISO
No reproduction or networking permitted without license from IHS
e ) the net contents of the components in grams or
millilitres;
9 the recommended storage conditions;
g) the expiry date expressed as year and month
according to I S 0 8601 when stored according to
the recommended conditions;
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h) the batch number referring to the manufacturer‘s
records.
NOTE 3 If the expiry date permits a clear identification
of the batch, it may replace the batch number.
10.2 Containers
Each container shall be marked with at least the
following information:
a) the name of the manufacturer:
b) the trade-name of the polymer-based crown and
bridge material;
c) the method of polymerization, e.g. pressure-,
heat-, self-, light- and/or UV radiation-curing;
d) the shade or description which can be related to
the manufacturer’s shade guide;
e) the net contents in grams or millilitres;
9 the recommended storage conditions:
g) the expiry date expressed as year and month
according to I S 0 8601 when stored according to
the recommended conditions;
h) the batch number referring to the manufacturer’s
records.
NOTE 4 If the expiry date permits a clear identification
ofthe batch, it can replace the batch number.
Not for Resale
 IS0 30477 72 m 4853703 0522711 723 m
IS0 10477:1992(E)

UDC 616.314-77:615.462:620.193
Descriptors: dentistry, dental materiais, resins, classification, specifications, tests, determination, stability, coiour.

Price based on 8 pages

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Copyright International Organization for Standardization

Provided by IHS under license with ISO
No reproduction or networking permitted without license from IHS Not for Resale