EN ISO 1567:2000

SLOVENSKI STANDARD
01-november-2001
1DGRPHãþD
SIST EN ISO 1567:2000
Dentistry - Denture base polymers (ISO 1567:1999)
Dentistry - Denture base polymers (ISO 1567:1999)
Zahnheilkunde - Prothesenkunststoffe (ISO 1567:1999)
Art dentaire - Polymeres pour base de protheses dentaires (ISO 1567:1999)
Ta slovenski standard je istoveten z: EN ISO 1567:2000
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 1567
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2000
ICS 11.060.10 Supersedes EN ISO 1567:1995
English version
Dentistry - Denture base polymers (ISO 1567:1999)
Art dentaire - Polymères pour base de prothèses dentaires Zahnheilkunde - Prothesenkunststoffe (ISO 1567:1999)
(ISO 1567:1999)
This European Standard was approved by CEN on 1 March 2000.
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, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Central Secretariat: rue de Stassart, 36  B-1050 Brussels
© 2000 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 1567:2000 E
worldwide for CEN national Members.

Page 2
Foreword
The text of the International Standard from Technical Committee ISO/TC 106 "Dentistry" of the International
Organization for Standardization (ISO) has been taken over as an European Standard by Technical
Committee CEN/TC 55 "Dentistry", the secretariat of which is held by DIN.
This European Standard replaces EN ISO 1567:1995
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 October 2000, and conflicting national standards shall be withdrawn
at the latest by October 2000.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark,
Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal,
Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of the International Standard ISO 1567:1999 has been approved by CEN as a European Standard
without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative).

Page 3
Annex ZA
(normative)
Normative references to international publications with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other publications. These
normative references are cited at the appropriate places in the text and the publications are listed hereafter. For
dated references, subsequent amendments to or revisions of any of these publications apply to this European
Standard only when incorporated in it by amendment or revision. For undated references the latest edition of
the publication referred to applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by (mod.), the relevant
EN/HD applies.
Publication Year Title EN/HD Year
ISO/DIS 463 1996 Geometrical product specifications (GPS) Dimensional prEN 463 1996
measuring instruments: Dial gauges - Design and
metrological requirements
ISO 1942-1 1989 Dental vocabulary - Part 1: General and clinical terms EN 21942-1 1991
ISO 1942-2 1989 Dental vocabulary - Part 2: Dental materials EN 21942-2 1992
ISO 1942-5 1989 Dental vocabulary - Part 5: Terms associated with EN ISO 1942-5 1994
testing
ISO 3336 1993 Dentistry - Synthetic polymer teeth EN ISO 3336 1996
ISO 3696 1987 Water for analytical laboratory use - Specification and EN ISO 3696 1995
test methods
ISO 7491 1985 Dental materials - Determination of colour stability of EN 27491 1991
dental polymeric materials
ISO 8601 1988 Data elements and interchange formats - Information EN 28601 1992
interchange - Representation of dates and times

INTERNATIONAL ISO
STANDARD 1567
Third edition
1999-02-15
Dentistry — Denture base polymers
Art dentaire — Polymères pour base de prothèses dentaires
A
Reference number
ISO 1567:1999(E)
ISO 1567:1999(E)
Contents
1 Scope .1
2 Normative references .1
3 Definitions .2
4 Classification.3
5 Requirements.3
6 Sampling.6
7 Preparation of test specimens .6
8 Test methods.6
9 Requirements for labelling, marking, packaging and instructions supplied by manufacturer .22
Annex A HPLC method for determination of MMA content.25
Annex B Bibliography .27
©  ISO 1999
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 iso@iso.ch
Printed in Switzerland
ii
© ISO
ISO 1567:1999(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.
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.
International Standard ISO 1567 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 2, Prosthodontic materials.
This third edition cancels and replaces the second edition (ISO 1567:1988), which has been technically revised.
Significant differences between this third edition and the second edition are:
 two new categories of material (light-activated and microwave-cured) have been added as Type 4 and Type 5
to Classification (clause 4);
 requirements and tests previously identified as transverse deflection properties are now identified as "flexural
strength" (5.2.7 and 8.5.3.5) and "flexural modulus" (5.2.8 and 8.5.3.5); the determination of flexural strength
and flexural modulus require force per unit area calculations;
 a requirement and tests for residual methyl methacrylate monomer content (5.2.10 and 8.7) have been added.
Annex A forms an integral part of this International Standard. Annex B is for information only.
iii
© ISO
ISO 1567:1999(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard, but it is recommended that, in assessing possible biological or toxicological hazards,
reference be made to ISO 10993-1 and ISO 7405.
iv
INTERNATIONAL STANDARD  © ISO ISO 1567:1999(E)
Dentistry — Denture base polymers
1 Scope
1.1  This International Standard classifies denture base polymers and copolymers and specifies their requirements.
It also specifies the test methods to be used in determining compliance with these requirements. It further specifies
requirements with respect to packaging and marking the products and to the instructions to be supplied for use of
these materials.
1.2  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 such details to be provided.
1.3  This International Standard applies to denture base polymers such as those listed below.
a) Poly(acrylic acid esters);
b) poly(substituted acrylic acid esters);
c) poly(vinyl esters);
d) polystyrene;
e) rubber-modified poly(methacrylic acid esters);
f) polycarbonates;
g) polysulfones;
h) poly(dimethacrylic acid esters);
i) polyacetals (polyoxymethylene);
j) copolymers or mixtures of the polymers listed in a) through i).
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this
International Standard. At the time of publication, the editions indicated were valid. All standards are subject to
revision, and parties to agreements based on this International Standard are encouraged to investigate the
possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain
registers of currently valid International Standards.
1)
ISO 463: — , Geometrical product specifications (GPS) — Dimensional measuring instruments: Dial gauges —
Design and metrological requirements.
ISO 1942-1:1989, Dental vocabulary — Part 1: General and clinical terms.

1)
To be published. (Revision of ISO 463:1988)
© ISO
ISO 1567:1999(E)
ISO 1942-2:1989, Dental vocabulary — Part 2: Dental materials.
ISO 1942-5:1989, Dental vocabulary — Part 5: Terms associated with testing.
ISO 3336:1993, Dentistry — Synthetic polymer teeth.
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods.
ISO 7491:1985, Dental materials — Determination of colour stability of dental polymeric materials.
ISO 8601:1988, Data elements and interchange formats — Information interchange — Representation of dates and
times.
3 Definitions
For the purposes of this International Standard, the following definitions apply.
3.1
autopolymerizable polymers
products having polymerization initiated by chemical means and not requiring application of verifiable temperatures
above 65 °C to complete the process
3.2
capsulated material
material consisting of two or more components supplied in a container which keeps them separated until the time
they are mixed together and dispensed for use directly from the container
3.3
denture
artificial substitute for missing natural teeth and adjacent tissues, to include also any additions needed for optimum
function
3.4
denture base
that part of a denture which rests on soft tissue foundations and to which teeth are added
3.5
heat-polymerizable polymer
product requiring application of verifiable temperatures above 65 °C to complete polymerization
3.6
immediate container
container which is in direct contact with the denture base materials
3.7
liquid
monomeric fluid to be mixed with polymeric particles to form a mouldable dough or fluid resin mixture used for
forming denture bases
3.8
outer packaging
labelled container or wrapping within which other containers are packed
3.9
packing
〈of a denture〉 the act of filling a denture base mould with a material (using a compression, pour or injection
technique) to form a denture base
© ISO
ISO 1567:1999(E)
3.10
initial packing time
time after mixing, or other preparation, at which a denture base material mixture first reaches packing consistency
3.11
final packing time
the last time, after reaching the initial packing time, at which a denture base material mixture retains packing
consistency
3.12
processing
procedure of preparing a solid denture base polymer plate and/or specimen by polymerization or injection moulding
3.13
thermoplastic, adj.
characteristic of a hard polymeric material that allows it to be softened by application of heat to make it mouldable,
and then return to the hardened state upon cooling
3.14
translucency
capacity of a body of material to allow the passage of light, yet diffusing the light so as not to render objects lying
beyond the body clearly visible
4 Classification
Denture base polymers covered by this International Standard are categorized into the following Types and
Classes:
Type 1 : Heat-polymerizable polymers
Class 1 : Powder and liquid
Class 2 : Plastic cake
Type 2 : Autopolymerizable polymers
Class 1 : Powder and liquid
Class 2 : Powder and liquid pour-type resins
Type 3 : Thermoplastic blank or powder
Type 4 : Light-activated materials
Type 5 : Microwave cured materials
5 Requirements
5.1 Unpolymerized material
5.1.1 Liquid component
5.1.1.1 General
The liquid shall consist essentially of monomeric material compatible with the powder.
© ISO
ISO 1567:1999(E)
5.1.1.2 Homogeneity
The liquid shall be free of deposit or sediment that can be observed by visual inspection (8.1).
5.1.2 Solid components
The solid or semisolid components shall be free of extraneous material that can be observed by visual inspection
(8.1).
5.1.3 Packing plasticity
When Type 1 Class 1, Type 1 Class 2, Type 2 Class 1, Type 2 Class 2, Type 4 and Type 5 materials are tested in
accordance with 8.2, at the initial packing time recommended by the manufacturer, they shall be capable of being
intruded into at least two holes in the die (see figure 1) to a depth of not less than 0,5 mm (8.2.3.1.1). Type 1 Class
1, Type 1 Class 2, Type 4 and Type 5 materials shall also meet the requirements when tested at the final packing
time (8.2.3.1.2)
5.2 Polymerized material
5.2.1 Biocompatibility
See the Introduction for guidance on biocompatibility
5.2.2 Surface characteristics
When processed in the manner and against materials recommended by the manufacturer, denture base specimens
prepared in accordance with 8.4.3, 8.7.2.2 and 8.8.3 should have a smooth, hard and glossy surface.
The specimens for colour stability, the specimens for residual methyl methacrylate monomer and the specimens for
sorption and solubility testing shall retain their form without visible distortion after processing.
When polished in accordance with 8.5.1.3, the specimen plates shall present a smooth surface with a high gloss
(8.1).
When prepared in accordance with the manufacturer's instructions, all types of denture base polymers shall
produce a test specimen plate (8.5.1) with defined edges after deflasking (see figure 3).
5.2.3 Colour
A specimens strip shall show no more than a slight difference when compared with the corresponding shade of the
shade guide, when tested in accordance with 8.3 and inspected in accordance with 8.1.
The manufacturer shall provide a shade guide on request.
Coloured denture base polymers shall be translucent (5.2.5 and 8.5.2) and evenly pigmented and/or, where
applicable, evenly fibred.
Clear denture base polymers shall be clear and colourless.
5.2.4 Colour stability
When tested in accordance with 8.4 and inspected in accordance with 8.1, test specimens shall not show more than
a slight change in colour, perceptible with difficulty.
5.2.5 Translucency
When tested in accordance with 8.5.2.3 the shadow of the illuminated opaque disc shall be visible from the opposite
side of the test specimen plate.
© ISO
ISO 1567:1999(E)
5.2.6 Freedom from porosity
When prepared in accordance with 8.5.3.3, specimens strips shall not show voids (8.1) that can be observed by
visual inspection.
5.2.7 Flexural strength
When determined in accordance with 8.5.3.5, the flexural strength shall be not less than 65 MPa for Type 1, Type 3,
Type 4 and Type 5 polymers and not less than 60 MPa for Type 2 polymers when tested in water at (37 ± 1) °C
(see table 1).
5.2.8 Flexural modulus
When determined in accordance with 8.5.3.5, the flexural modulus of the processed polymer shall be at least
2 000 MPa for Type 1, Type 3, Type 4 and Type 5 polymers and at least 1 500 MPa for Type 2 polymers when
tested in water at (37 ± 1) °C (see table 1).
5.2.9 Bonding to synthetic polymer teeth
Denture base polymers intended for use with synthetic polymer teeth shall meet one of the following requirements.
a) The polymer shall, when tested in accordance with 8.6, be capable of bonding to polymer teeth complying with
the bonding requirements of ISO 3336.
b) If there are problems of achieving bonding, the outer packages and containers shall contain information about
special treatments necessary to achieve bonding and/or indicate that further information is provided in the
manufacturer’s instructions [8.6.3, 9.2.1 k), 9.2.2 k), and 9.3 h)].
5.2.10 Residual methyl methacrylate monomer
When prepared and tested in accordance with 8.7, the following shall apply (see table 1).
The upper limit (maximum) for residual methyl methacrylate is 2,2 % mass fraction for denture base polymers of
Type 1, Type 3, Type 4 and Type 5.
The upper limit (maximum) for residual methyl methacrylate is 4,5 % mass fraction for denture base polymers of
Type 2.
If lower percentages of residual methyl methacrylate monomer are claimed by the manufacturer, the content shall
not be more than 0,2 % higher than that stated by the manufacturer.
5.2.11 Sorption
When the processed polymer is tested in accordance with 8.8, the increase in volumic mass (water sorption) shall
not exceed 32 μg/mm for Type 1, Type 2, Type 3, Type 4 or Type 5 polymers (see table 1).
5.2.12 Solubility
When the processed polymer is tested in accordance with 8.8, the loss in volumic mass (soluble matter) shall not
3 3
exceed 1,6 μg/mm for Type 1, Type 3, Type 4 or Type 5 polymers, and shall not exceed 8,0 μg/mm for Type 2
polymers (see table 1).
© ISO
ISO 1567:1999(E)
Table 1 — Summary of the limits for requirements described in 5.2.7, 5.2.8, 5.2.10, 5.2.11 and 5.2.12
Requirement Flexural Flexural Residual methyl Sorption Solubility
strength modulus methacrylate
monomer
3 3
[MPa] [MPa] Percent mass fraction [μg/mm ] [μg/mm ]
min. min. max. max. max.
Type 1,3,4,5 65 2000 2,2 32 1,6
Type 2 60 1500 4,5 32 8,0
6 Sampling
The test sample shall consist of a retail package or packages, containing sufficient material to carry out the
specified tests, plus an allowance for any necessary repetition of the tests. If more than one package is required, all
material shall be of the same batch.
7 Preparation of test specimens
7.1 Laboratory environment
Unless otherwise specified in this International Standard or the manufacturer's instructions, the test specimens shall
be prepared and tested at (23 ± 2) °C and (50 ± 10) % relative humidity.
7.2 Procedures
Unless otherwise specified in this International Standard, the materials used for making the specimens shall be
prepared, manipulated and processed using the equipment and procedures recommended in the manufacturer's
instructions (9.3)
A separate mix shall be made for each specimen prepared from a material requiring mixture of two or more
ingredients.
7.3 Special equipment
Any special equipment specified by the manufacturer for processing a material shall be made available by the
manufacturer (or the manufacturer may prepare injection-moulded specimens, and submit them to the test
laboratory).
8 Test methods
8.1 Inspection for compliance determination
Observe the test samples by visual inspection to determine compliance with the requirements laid down in 5.1.1.2,
5.1.2, 5.2.2, 5.2.3, 5.2.4, 5.2.5, 5.2.6 and clause 9. [Inspect for colour (5.2.3) and colour stability (5.2.4) in
accordance with ISO 7491].
8.2 Packing plasticity
8.2.1 Apparatus
8.2.1.1  Perforated brass die, having the dimensions shown in figure 1, with perforations having a diameter of
(0,75 ± 0,05) mm.
© ISO
ISO 1567:1999(E)
Dimensions in millimetres
NOTE Dimensional tolerances not specified shall be ± 1 mm
Figure 1 — Perforated brass die for packing plasticity test (see 8.2)
8.2.1.2  Glass plate, (60 ± 5) mm x (60 ± 5) mm x (5 ± 1) mm.
8.2.1.3  Weight, capable of exerting a force of (50 ± 1) N.
8.2.1.4  Polyethylene or polyester film, 0,035 mm to 0,050 mm thick and approximately 50 mm by 50 mm.
8.2.1.5  Dial gauge, complying with ISO 463, or linear gauge accurate to 0,01 mm, equipped with a probe capable
of entering holes in the brass die for measuring depth of penetration of the material into the die.
8.2.2 Test conditions
The perforated brass die (8.2.1.1) and glass plate (8.2.1.2) shall be maintained at conditions specified in 7.1, except
where otherwise specified by the manufacturer.
8.2.3 Procedure
8.2.3.1 For Type 1 Class 1, Type 1 Class 2, Type 4 and Type 5
8.2.3.1.1 Initial packing time
Prepare a sample of the material having a mass of 16 g to 20 g. Immediately prior to the manufacturer's
recommended initial packing time [9.3 e)], shape one-half of the sample into a cake approximately 5 mm thick,
© ISO
ISO 1567:1999(E)
place it on the upper surface of the brass die (8.2.1.1) and cover it with a plastic sheet (8.2.1.4). At the
recommended initial packing time, place the glass plate (8.2.1.2) and the weight (8.2.1.3) on the plastic-covered
resin cake. After 10 min ± 30 s, remove the weight. When the material is firm, introduce the measuring instrument
probe into each hole from the other side of the brass die, to contact the penetrating material to determine the depth
in the hole not penetrated.
Calculate the depth of penetration for each hole according to the following formula:
DP = d 2 d'
where
DP is the depth of penetration, in millimetres;
is the thickness of the brass die, in millimetres;
d
d' is the the depth not penetrated, in millimetres.
8.2.3.1.2 Final packing time
Immediately before the final packing time [9.3 e)] recommended by the manufacturer, shape the second half of the
sample into a cake and test this portion according to 8.2.3.1.1.
8.2.3.2 For Type 2, Class 1
Prepare a sample having a mass 8 g to 10 g. Shape this increment and test it according to the procedure described
in 8.2.3.1.1
8.2.3.3 For Type 2, Class 2
Prepare a sample having a mass 8 g to 10 g. Introduce this increment onto the top surface of the brass die at the
time recommended by the manufacturer [9.3d)] for pouring the fluid mix into the mould. Determine the depth of
penetration values according to the procedure in 8.2.3.1.1
8.2.4 Pass/fail determinations
If the first specimen fails to comply with the requirement stated in 5.1.3, test two additional specimens. If the second
and third specimens comply with the requirement, the product passes.
8.2.5 Expression of results
Report the number of holes penetrated to a depth of not less than 0,5 mm by each specimen, and whether the
material passes or fails.
8.3 Colour
Compare a specimen strip prepared in accordance with 8.5.3.3, and inspected in accordance with 8.1, with the
shade guide for compliance with 5.2.3.
8.4 Colour stability
8.4.1 Materials
8.4.1.1  Sheet of polyester film, having a thickness of (50 ± 25) μm, to cover the steel mould (8.4.2.1).
8.4.1.2  Aluminium foil.
8.4.2 Apparatus
8.4.2.1  Stainless steel mould and cover (Type 1 and Type 2 materials), having the dimensions shown in
figure 2, mounted in gypsum in separate halves of a denture flask.
© ISO
ISO 1567:1999(E)
Dimensions in millimetres
Key
1 Mould depth to form specimen 0,5 – 0,05
2 Mould
3 Cover
NOTE Dimensional tolerances not specified shall be ± 0,2 mm.
Figure 2 — Stainless steel mould and cover for colour stability, sorption and solubility (see 8.4 and 8.8)
8.4.2.2  Moulds and/or equipment (Type 2 Class 2, Type 3, Type 4, Type 5 and capsulated materials)
recommended by the manufacturer to produce specimens with the dimensions specified in 8.4.3.
8.4.2.3  Hydraulic or hand press and clamp, where applicable.
8.4.2.4  Water bath, capable of maintaining constant temperatures, where applicable.
8.4.2.5  Oven, capable of being maintained at (37 ± 1) °C.
8.4.2.6  Micrometer or dial calliper, accurate to 0,01 mm and fitted with parallel anvils.
8.4.2.7  Radiation source and test chamber, see 3.1.1 and 3.1.3 of ISO 7491:1985.
8.4.3 Preparation of test specimens
8.4.3.1 Type 1 and Type 2 materials
Make two specimens from separate mixes. Mix the resin and pack the mixture into the mould (8.4.2.1) with the
polyester film (8.4.1.1) against the steel cover of the mould. Process the mixture in accordance with the
manufacturer's instructions, but retain the polyester film during the processing cycle.
© ISO
ISO 1567:1999(E)
8.4.3.2 Type 2 Class 2, Type 3, Type 4, Type 5 and capsulated materials
Prepare the specimens as described by the manufacturer.
Check with a micrometer or dial calliper (8.4.2.6) to ensure that each specimen has a diameter of (50 ± 1) mm and
a thickness of (0,5 ± 0,1) mm and that the top and bottom surfaces are flat.
8.4.4 Procedure
Store the two specimens in the oven (8.4.2.5) for 24 h ± 30 min. Then store one specimen in the dark in laboratory
environment (7.1) until the colour comparison test is made.
Cover half of the second specimen with aluminium foil (8.4.1.2) and transfer it to the radiation source and test
chamber (8.4.2.7). The specimen shall be immersed in water at (37 ± 5) °C when exposed to the radiation for
24 h ± 30 min in accordance with ISO 7491. After exposure, remove the aluminium foil before colour comparison of
the specimens including the unexposed specimen.
The colour comparison shall be carried out in accordance with the requirements specified in 5.2.4 of this
International Standard and in accordance with the procedure for colour comparison laid down in ISO 7491.
For Type 4 materials, store the exposed specimen in laboratory environment (7.1) for 6 d ± 2 h until the colour
comparison test is made.
8.5 Polishability, translucency, freedom from porosity, flexural strength and flexural modulus
8.5.1 Polishability
8.5.1.1 Apparatus
8.5.1.1.1  Denture flask, capable of accommodating the test specimen plate so that the corners are not less than
5 mm from the walls of the flask.
8.5.1.1.2  Model of the specimen plate, in metal or polymer (see figure 3).
Dimensions in millimetres
NOTE Dimensional tolerances shall be ± 1 mm.
Figure 3 — Model of the specimen plate (see 8.5)
8.5.1.1.3  Equipment for processing the resin, including gypsum or hydrocolloid [9.3 f)].
8.5.1.1.4  Standard metallographic grinding paper, with a grain size of approximately 30 μm.
© ISO
ISO 1567:1999(E)
NOTE Grinding paper with a 500 FEPA (Fédération europénne des produits abrasifs: European Federation for Abrasive
Products) standard number is recommended; however any other paper meeting the same requirements is suitable.
8.5.1.1.5  Wet pumice, having a grain size of approximately 10 μm to 20 μm.
8.5.1.1.6  Polishing compound.
8.5.1.1.7  Muslin wheel, with 16 to 36 ply, having a diameter of 70 mm to 95 mm and at least 10 mm between the
outer diameter and the stitching or other reinforcement.
8.5.1.1.8  Unstitched muslin wheel, with 16 to 36 ply, having a diameter of 70 mm to 95 mm.
8.5.1.2 Preparation of the mould
For Type 1 and Type 2 Class 1 polymers, invest the model of the specimen plate (8.5.1.1.2) in the denture flask
(8.5.1.1.1) in accordance with the manufacturer's instruction. Prepare the mould for Type 2 Class 2 ,Type 3, Type 4,
Type 5 and capsulated materials in accordance with the manufacturer's instructions.
8.5.1.3 Procedure
Form and process according to the manufacturer's instruction two specimen plates each from a separate mix. Use
the material, the equipment (8.5.1.1) and the mould (8.5.1.2). Grind and polish surfaces of the specimen plates for
not longer than 1 min with pumice (8.5.1.1.5) and with a wet muslin wheel (8.5.1.1.7) at a circumferential speed of
–1
(650 ± 350) m/min. (A wheel with a diameter of 70 mm rotating at 1 500 min will have a cirumferential speed of
–1
329 m/min and a 100 mm diameter wheel rotating at 3 500 min will have a circumferential speed of 1 100 m/min).
Thereafter polish with an unstitched muslin wheel (8.5.1.1.8) with a polishing compound (8.5.1.1.6). After polishing
and cleaning, examine the polished surfaces for compliance with 5.2.2.
8.5.1.4 Pass/fail determination
If both specimen plates comply with 5.2.2, the material passes. If both specimen plates fail to comply with 5.2.2, the
material fails. If only one of the specimen plates complies, prepare and evaluate three new plates. The material
passes only if all three new plates comply.
8.5.1.5 Expression of results
Report the number of specimen plates evaluated, the number complying and whether the material passes.
8.5.2 Translucency
8.5.2.1 Materials
8.5.2.1.1  Two specimen plates, prepared and tested according to 8.5.1.
8.5.2.2 Apparatus
8.5.2.2.1  Opaque disc, of diameter (10 ± 1) mm and thickness (2 ± 1) mm.
8.5.2.2.2  Frosted 40 W electrical light bulb.
8.5.2.3 Procedure
Examine each of the two specimen plates separately. Position the polished specimen plate approximately 500 mm
from the light bulb (8.5.2.2.2) with the opaque disc (8.5.2.2.1) centred on the surface nearest the light bulb. Darken
the room. View the specimen plate from the side opposite the disc location to determine whether the material
complies with 5.2.5.
© ISO
ISO 1567:1999(E)
8.5.2.4 Pass/fail determination
If both specimen plates comply with 5.2.5, the material passes. If both specimen plates fail, the material fails. If only
one of the specimen plates passes, prepare and evaluate three new plates. The material passes only if all three
new plates comply.
8.5.2.5 Expression of results
Report the number of specimen plates evaluated, the number complying and whether the material passes.
8.5.3 Freedom from porosity, flexural strength and flexural modulus
8.5.3.1 Materials
8.5.3.1.1  Two specimen plates, prepared and tested according to 8.5.1 and 8.5.2.
8.5.3.2 Apparatus
8.5.3.2.1  Sawing machine, or other cutting device for sectioning the specimen plates.
8.5.3.2.2  Milling machine, or other instrumentation for air or water cooled cutting so as not to generate
temperatures above 30 °C during shaping of the specimens. (A machine with a milling head and a sharp carbide
edge, is suitable.)
8.5.3.2.3  Standard metallographic grinding papers, having a grain size of approximately 30 μm (500 FEPA)
and 14 μm (1200 FEPA). See note in 8.5.1.1.4.
8.5.3.2.4  Micrometer, and/or dial calliper accurate to 0,01 mm and fitted with parallel anvils.
8.5.3.2.5  Container of water, for storing the specimen strips at (37 ± 1) °C for pre-test conditioning.
8.5.3.2.6  Testing machine, calibrated to provide for a constant crosshead speed of (5 ± 1) mm/min and equipped
with instrumentation for measuring the deflection of the specimen to within 0,025 mm. Any load exerted by the
deflection instrument shall be accounted for when calibrating the machine.
8.5.3.2.7  Flexural test rig, consisting of a central loading plunger and two polished cylindrical supports, 3,2 mm in
diameter and at least 10,5 mm long. The supports shall be parallel to within 0,1 mm and perpendicular to the
longitudinal centreline. The distance between centres of the supports shall be (50 ± 0,1) mm, and the loading
plunger shall be midway between the supports to within 0,1 mm. Means to prevent misalignment of the specimen
shall be included in the design.
8.5.3.2.8  Water bath, for maintaining the specimens wet and at a temperature of (37 ± 1) °C, during testing.
8.5.3.3 Procedure
Prepare six specimen strips. Cut each plate lengthways into three equal strips, 64 mm long, (10,0 ± 0,2) mm wide
and (3,3 ± 0,2) mm in height. Machine the strips in a milling machine (8.5.3.2.2) on the edges and equally from both
moulded surfaces so that the dimensions remain slightly oversized. Take care to avoid overheating the specimen.
Wet-grind all faces and edges smooth and flat with the metallographic grinding papers (8.5.3.2.3) to the required
width and height. Three measurements of the specimen height shall be made along the long axis with an accuracy
of ± 0,01 mm. The deviation between the three measurements along the long axis shall be not more than
± 0,02 mm. The specimen shall be flat and have an even height.
8.5.3.4 Freedom from porosity
8.5.3.4.1 Pass/fail determination
Six test specimen strips shall be prepared in accordance with 8.5.3.3 and examined for compliance with 5.2.6.
© ISO
ISO 1567:1999(E)
The material passes only if at least five out of six specimen strips comply with the requirement in 5.2.6.
8.5.3.4.2 Expression of results
Report the number of specimen strips complying and whether the material passes.
8.5.3.5 Flexural strength and flexural modulus
8.5.3.5.1 Procedure
Store the five or six specimen strips, prepared according to 8.5.3.3 and complying with 5.2.6, in water at a
temperature of (37 ± 1) °C for (50 ± 2) h prior to flexural testing. Take a specimen strip from water storage and
immediately lay the flat surface symmetrically on the supports of the flexural test rig (8.5.3.2.7) immersed in the
water bath (8.5.3.2.8). Allow the specimen to come to equilibrium with the water bath temperature.
Increase the force on the loading plunger from zero, uniformly, using a constant crosshead speed of (5 ± 1) mm/min
until the specimen breaks.
8.5.3.5.2 Calculation and expression of results
8.5.3.5.2.1 Flexural strength
Calculate the flexural strength, s, in megapascals from the following equation:
3Fl
s=
2bh
where
F is the maximum load, in newtons, exerted on the specimen;
l is the distance, in millimetres, between the supports, accurate to ± 0,01 mm;
b is the width, in millimetres, of the specimen measured immediately prior to water storage;
h is the height, in millimetres, of the specimen measured immediately prior to water storage.
8.5.3.5.2.2 Flexural modulus
Calculate the flexural modulus E, in megapascals, from the following equation:
Fl
E =
4bh d
where
F is the load, in newtons, at a convenient point in the straight-line portion of the trace;
NOTE For greater accuracy, the straight line may be extended.
d is the deflection, in millimetres, at load F ;
l, b and h are as defined in 8.5.3.5.2.1.
8.5.3.5.2.3 Pass/fail determination of flexural strength
If at least four of the results out of five specimens are not less than 65 MPa for Type 1, Type 3, Type 4 and Type 5
polymers and not less than 60 MPa for Type 2 polymers, the material is deemed to have complied with the
requirements of 5.2.7.
© ISO
ISO 1567:1999(E)
If at least three of the results are less than 65 MPa for Type 1, Type 3, Type 4 and Type 5 polymers and less than
60 MPa for Type 2 polymers, the material is deemed to have failed absolutely.
If two of the results are less than 65 MPa for Type 1, Type 3, Type 4 and Type 5 polymers and 60 MPa for Type 2
polymers, repeat the whole test but on this occasion prepare six specimen strips.
If at least five of the results are not less than 65 MPa for Type 1, Type 3, Type 4 and Type 5 polymers and not less
than 60 MPa for Type 2 polymers on the second occasion, the material is deemed to have complied with the
requirements of 5.2.7.
8.5.3.5.2.4 Pass/fail determination of flexural modulus
If at least four of the results passed the requirements of 5.2.7 on the first occasion, calculate the flexural modulus
according to 8.5.3.5.2.2 for each of the five specimens.
If a second series was tested, calculate the flexural modulus for five of the six specimens from this series only.
If at least four of the results are not less than 2 000 MPa for Type 1, Type 3, Type 4 and Type 5 polymers and not
less than 1 500 MPa for Type 2 polymers the material is deemed to have complied with the requirements of 5.2.8.
If at least three of the results are less than 2 000 MPa for Type 1, Type 3, Type 4 and Type 5 polymers and less
than 1 500 MPa for Type 2 polymers, the material is deemed to have failed absolutely.
If two of the results are less than 2 000 MPa for Type 1, Type 3, Type 4 and Type 5 polymers and less than
1 500 MPa for Type 2 polymers, repeat the whole test, but on this occasion prepare six specimen strips. In this
series, at least five results for both flexural strength and flexural modulus shall comply with the requirements of 5.2.7
and 5.2.8.
8.5.3.5.2.5 Expression of results
Report the number of specimen strips evaluated, all results for flexural strength and flexural modulus with the
number of strips complying with the 5.2.7 and 5.2.8, and whether the material passes.
8.6 Bonding to synthetic polymer teeth
8.6.1 Materials
8.6.1.1  Maxillary anterior synthetic polymer teeth complying with ISO 3336.
8.6.1.2  Dental mounting wax.
8.6.2 Apparatus
8.6.2.1  Metal form, of the design illustrated in figure 3 a) of ISO 3336:1993, which incorporates a trough 5 mm
wide by 1,5 mm deep for use in mounting the teeth.
8.6.2.2  Normal dental laboratory apparatus for denture flasking and processing, including gypsum or
hydrocolloid [9.3 f)].
8.6.2.3  Tensile testing apparatus with specially designed grips illustrated in figure 3 c) of ISO 3336:1993.
8.6.3 Procedure
Grind the ridge lap of a set of six maxillary anterior teeth (8.6.1.1). Mount these teeth on a metal form (8.6.2.1) with
wax (8.6.1.2), as illustrated in figure 3 a) of ISO 3336:1993, so that about one-half of the lingual surface of the
incisal portion of the tooth projects beyond the metal form.
© ISO
ISO 1567:1999(E)
Using a denture flask (8.6.2.2), set the mounted teeth in dental gypsum [figure 3 b) of ISO 3336:1993]. Remove the
metal form and then flush the wax from the teeth with boiling tap-water containing a detergent until all wax has been
removed, followed by rinsing several times with boiling tap-water. Prepare and process the denture base polymer to
the teeth according to the manufacturer's instructions (9.3) after proper plasticity has been reached. Test the
denture base-mounted teeth in the tensile testing apparatus (8.6.2.3) designed to permit a direct pull on the incisal
part of the lingual surface in a labial direction at a consistent height above the acrylic bar [figure 3 c) of
ISO 3336:1993]. Use equipment which does not permit lateral deflection or change of position.
Load each tooth, as illustrated in figure 3 c) of ISO 3336:1993, at a displacement rate in the range 0,5 mm/min to
10 mm/min until fracture occurs.
8.6.4 Pass/fail determination
The bond passes the test if the fracture path does not occur cleanly along the tooth surface. Thus, tooth remnants
shall remain bonded to the denture base polymer and/or denture base polymer shall remain firmly bonded to the
detached tooth or the adhesive shall remain firmly bonded to both detached tooth and denture base.
NOTE Only pure adhesive interfacial fracture indicates a failure to meet the requirement. Cohesive fracture in either the tooth,
the denture base polymer or an adhesive, is necessary for a satisfactory bond.
If at least five maxillary anterior teeth pass the test, the denture base polymer is deemed to comply with the
requirement of 5.2.9.
If only three comply, the denture base polymer fails.
If only four comply, prepare an additional denture base polymer with six maxillary anterior teeth from one set. If at
least five maxillary anterior teeth pass this second test, the denture base polymer is deemed to comply with the
requirement.
8.6.5 Expression of results
Report the number of teeth for which the bond passes the test.
8.7 Residual methyl methacrylate monomer
8.7.1 Principle
Solvent extraction of the methyl methacrylate (MMA) monomer from polymerized denture base materials is carried
out, followed by chromatographic analyses.
A gas chromatographic (GC) method, high performance liquid chromatography (HPLC) method (annex A) or any
other chromatographic method which gives the same results as the methods of this International Standard can be
used. This shall be verified by proficiency testing based on the chromatographic methods described in this
International Standard.
8.7.2 Preparation of test specimen discs
8.7.2.1 Apparatus
8.7.2.1.1  Circular stainless steel mould (Type 1 and Type 2), with a diameter of 50 mm and a depth of
(3,0 ± 0,1) mm with a flat cover. A similar mould (less deep) is shown in figure 2. The mould shall be mounted in
gypsum in separate halves of a denture flask.
8.7.2.1.2  Moulds and/or equipment (Type 2 Class 2, Type 3, Type 4, Type 5 and capsulated materials)
recommended by the manufacturer to produce specimens with the dimensions specified in 8.7.2.1.1.
8.7.2.1.3  Standard metallographic grinding papers, with a grain size of approximately 30 μm (500 FEPA) and
15 μm (1200 FEPA). See note of 8.5.1.1.4.
© ISO
ISO 1567:1999(E)
8.7.2.2 Procedure
Prepare three specimens from three separate mixes as described in 8.4.3, except that the mould shall have the
dimensions given in 8.7.2.1.1. Keep the specimens in the dark at laboratory environment (7.1) for (24 ± 5) h prior to
grinding. Use the metallographic grinding papers (8.7.2.1.3) in turn, to wet-grind material equally from both sides of
the specimen disc, until a thickness of (2,0 ± 0,1) mm is obtai
...