EN ISO 4049:2009

SLOVENSKI STANDARD
01-januar-2010
1DGRPHãþD
SIST EN ISO 4049:2000
Zobozdravstvo - Restavrativni materiali na osnovi polimerov (ISO 4049:2009)
Dentistry - Polymer-based restorative materials (ISO 4049:2009)
Zahnheilkunde - Restaurative Kunststoffe (ISO 4049:2009)
Art dentaire - Produits d'obturation, de restauration et de scellement à base de
polymères (ISO 4049:2009)
Ta slovenski standard je istoveten z: EN ISO 4049:2009
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 4049
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2009
ICS 11.060.10 Supersedes EN ISO 4049:2000
English Version
Dentistry - Polymer-based restorative materials (ISO 4049:2009)
Art dentaire - Produits de restauration à base de polymères Zahnheilkunde - Polymerbasierende
(ISO 4049:2009) Restaurationsmaterialien (ISO 4049:2009)
This European Standard was approved by CEN on 24 September 2009.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4049:2009: E
worldwide for CEN national Members.

Contents Page
Foreword .3

Foreword
This document (EN ISO 4049:2009) 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 2010, and conflicting national standards shall be withdrawn at the
latest by April 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 4049:2000.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 4049:2009 has been approved by CEN as a EN ISO 4049:2009 without any modification.

INTERNATIONAL ISO
STANDARD 4049
Fourth edition
2009-10-01
Dentistry — Polymer-based restorative
materials
Art dentaire — Produits de restauration à base de polymères

Reference number
ISO 4049:2009(E)
©
ISO 2009
ISO 4049:2009(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2009
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 either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2009 – All rights reserved

ISO 4049:2009(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 Physical and chemical properties .2
5.3 Shade, restorative materials .4
5.4 Colour stability after irradiation and water sorption .4
5.5 Radio-opacity.4
6 Sampling .5
7 Test methods .5
7.1 General reagent — Water .5
7.2 Test conditions.6
7.3 Inspection.6
7.4 Preparation of test specimens .6
7.5 Measurement of film thickness of luting materials.6
7.6 Working time, Class 1 and Class 3 restorative materials, excluding luting materials.9
7.7 Working time, Class 1 and Class 3 luting materials .11
7.8 Setting time, Class 1 and Class 3 materials .11
7.9 Sensitivity to ambient light, Class 2 materials .13
7.10 Depth of cure, Class 2 materials.14
7.11 Flexural strength .15
7.12 Water sorption and solubility.18
7.13 Shade and colour stability after irradiation and water sorption.21
7.14 Radio-opacity.22
8 Packaging, marking and instructions and information to be supplied by the manufacturer.25
8.1 Packaging.25
8.2 Marking.25
8.3 Manufacturer’s instructions and information for the user.27
Bibliography.28

ISO 4049:2009(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 4049 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This fourth edition cancels and replaces the third edition (ISO 4049:2000) which has been reviewed and
essentially reconfirmed. Several minor changes have been made to clarify content. Changes have been made
to the test method for radio-opacity (see 7.14) in order to simplify this test.
iv © ISO 2009 – All rights reserved

ISO 4049:2009(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
International Standard, but it is recommended that when assessing possible biological or toxicological
hazards, reference should be made to ISO 10993-1 and ISO 7405.

INTERNATIONAL STANDARD ISO 4049:2009(E)

Dentistry — Polymer-based restorative materials
1 Scope
This International Standard specifies requirements for dental polymer-based restorative materials supplied in
a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and
intended for use primarily for the direct or indirect restoration of cavities in the teeth and for luting.
The polymer-based luting materials covered by this International Standard are intended for use in the
cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges.
This International Standard does not cover those polymer-based luting materials that have an adhesive
component within the structure of the material.
This International Standard does not cover materials intended to prevent caries (see ISO 6874) or those used
for veneering metal sub-frames (see ISO 10477).
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 1942, Dentistry — Vocabulary
ISO 3665, Photography — Intra-oral dental radiographic film — Specification
ISO 3696, Water for analytical laboratory use — Specification and test methods
ISO 7491, Dental materials — Determination of colour stability
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates and
times
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
3.1
opaque luting material
intensely pigmented polymer-based luting material intended to mask underlying materials and tooth structure
3.2
opaque
shade of an intensely pigmented polymer-based restorative material
ISO 4049:2009(E)
4 Classification
For the purposes of this International Standard, dental polymer-based restorative materials are classified as
the following types.
a) Type 1: polymer-based restorative materials claimed by the manufacturer as suitable for restorations
involving occlusal surfaces;
b) Type 2: all other polymer-based restorative materials, and luting materials.
The three classes of dental polymer-based restorative materials are as follows.
⎯ Class 1: materials whose setting is effected by mixing an initiator and activator (“self-curing” materials).
⎯ Class 2: materials whose setting is effected by the application of energy from an external source, such as
blue light or heat [“external-energy-activated” materials, see also 8.3 e)]. They are subdivided as follows:
1) Group 1: materials whose use requires the energy to be applied intra-orally;
2) Group 2: materials whose use requires the energy to be applied extra-orally. When fabricated, these
materials will be luted into place.
Certain materials may be claimed by manufacturers to be both Group 1 and Group 2. In this event, the
material should fulfil the requirements for both groups.
NOTE Class 2 luting materials will fall into Group 1 only.
⎯ Class 3: materials that are cured by the application of external energy and also have a self-curing
mechanism present (“dual cure” materials).
5 Requirements
5.1 Biocompatibility
See the Introduction for guidance on biocompatibility. Further information is available in ISO 7405 and
ISO 10993-1.
5.2 Physical and chemical properties
5.2.1 General
If a restorative material is supplied by the manufacturer in various shades, each shade, including opaque
shades, shall be capable of satisfying all the requirements for sensitivity to ambient light (5.2.7), depth of cure
(5.2.8), shade (5.3) and colour stability (5.4) appropriate to the material type and class. If the material is
supplied such that it can be “tinted” or “blended” to the user’s prescription, the material shall comply with the
requirements both when used alone and when used with the maximum recommended proportion of tint or
blender [see 8.3 d)].
Similarly, if the manufacturer supplies a luting material in various shades, each shade, including opaque luting
materials, shall be capable of satisfying all the requirements for depth of cure (5.2.8). Colour stability (5.4) of
luting materials shall not be tested unless the manufacturer claims such a property.
In respect of the other requirements of 5.2 and those of 5.5, only one representative shade of restorative
material shall be tested. This representative shade shall be either that classified by the manufacturer as
2 © ISO 2009 – All rights reserved

ISO 4049:2009(E)
® 1)
“universal” or, in the event that no shade is so classified, that shade corresponding to “A3” in the Vita
classification of shade. However, if the manufacturer claims a higher value for radio-opacity [see 5.5 and
8.3 o)] for any other shade, this claim shall be tested.
The requirements are summarised in Tables 1, 2 and 3.
5.2.2 Film thickness, luting materials
The film thickness of luting materials when determined in accordance with 7.5 shall be no more than 10 µm
above any value claimed by the manufacturer and in any event shall be no greater than 50 µm.
5.2.3 Working time, Class 1 and Class 3 restorative materials, excluding luting materials
The working time for Class 1 and Class 3 restorative materials, excluding luting materials, determined in
accordance with 7.6, shall be not less than 90 s.
5.2.4 Working time, Class 1 and Class 3 luting materials
When tested in accordance with 7.7, the material shall be capable of forming a thin layer; during its formation
there shall be no detectable change in its homogeneity.
5.2.5 Setting time, Class 1 materials
The setting time for Class 1 restorative materials, excluding luting materials, determined in accordance with
7.8, shall be not more than 5 min. The setting time for Class 1 luting materials, determined in accordance with
7.8, shall be not more than 10 min.
5.2.6 Setting time, Class 3 materials
The setting time for Class 3 materials, determined in accordance with 7.8, shall be not more than 10 min.
5.2.7 Sensitivity to ambient light, Class 2 materials
When tested in accordance with 7.9, the material shall remain physically homogeneous.
5.2.8 Depth of cure, Class 2 materials
When determined in accordance with 7.10, the depth of cure of Class 2 restorative materials, excluding luting
materials, shall be not less than 1 mm if they are labelled by the manufacturer as opaque, or not less than
1,5 mm for other restorative materials.
The depth of cure of luting materials when determined in accordance with 7.10 shall be not less than 0,5 mm if
they are labelled by the manufacturer as opaque materials, or not less than 1,5 mm for other materials.
In any event, the values for all materials, with the exception of opaque luting materials, shall be no more than
0,5 mm below the value stated by the manufacturer.
5.2.9 Flexural strength
The flexural strength of polymer-based restorative materials determined in accordance with 7.11 shall be
equal to or greater than the limits specified in Table 1.
®
1) Vita is a trade name of Vita Zahnfabrik, H Rauter GmbH & Co K G, Postfach 1338, D-79704 Bad Sackingen,
Germany. This information is given for the convenience of the users of this International Standard and does not constitute
an endorsement of this system by ISO.
ISO 4049:2009(E)
Table 1 — Flexural strength
Flexural strength
Restorative Materials
MPa minimum
Class 1 80
Class 2, Group 1 80
Type 1
Class 2, Group 2 100
Class 3 80
Class 1 50
Type 2
(including luting Class 2, Group 1 50
materials)
Class 3 50
5.2.10 Water sorption and solubility
When determined in accordance with 7.12:
a) the water sorption of all materials shall be u 40 µg/mm .
b) the solubility of all materials shall be u 7,5 µg/mm .
5.3 Shade, restorative materials
When the material is assessed in accordance with 7.13 and ISO 7491, the shade of the set material shall
match closely that of the manufacturer’s shade guide. If a shade guide is not supplied by the manufacturer,
then the manufacturer shall nominate a commercially available shade guide that shall be used in assessing
compliance with this requirement [see 8.3 l)]. In addition, the set material shall be evenly pigmented when
viewed without magnification.
5.4 Colour stability after irradiation and water sorption
When the material is tested in accordance with 7.13 and ISO 7491, no more than a slight change in colour
shall be observed. In respect of luting materials, colour stability shall be tested only in the event of a
manufacturer’s claim for colour stability. In the event of such a claim, no more than a slight change in colour
shall be observed after the material has been tested in accordance with 7.13 and ISO 7491.
5.5 Radio-opacity
5.5.1 If the manufacturer claims that the material is radio-opaque [see 8.2.3 h)], the radio-opacity,
determined in accordance with 7.14, shall be equal to or greater than that of the same thickness of aluminium
and no less than 0,5 mm below any value claimed by the manufacturer.
5.5.2 This test shall be performed on a “universal” shade (see 5.2.1), but if the manufacturer claims a value
for one or more other shades that is at least twice the “universal” shade value, this other shade or shades
shall be tested as described in 5.5.1 [see 8.3 o)].
NOTE Aluminium has a radio-opacity equivalent to that of dentine, thus 1 mm of material having a radio-opacity
equivalent to 1 mm of aluminium has a radio-opacity equivalent to that of dentine.
4 © ISO 2009 – All rights reserved

ISO 4049:2009(E)
Table 2 — Physical and chemical property requirements for restorative materials,
excluding luting materials (see Table 1 for minimum flexural strength)
Requirement (subclause)
a
Working time Setting time Water sorption Solubility
Depth of Cure
Material
(5.2.10) (5.2.10)
(5.2.3) (5.2.5, 5.2.6) (5.2.8)
Class
3 3
s min mm µg/mm µg/mm
minimum maximum
minimum maximum maximum
Class 1 90 — 40 7,5
(5.2.5)
1,0 (opaque shade)
Class 2 — — 40 7,5
1,5 (others)
Class 3 90 — 40 7,5
(5.2.6)
a
The values for all materials shall be no more than 0,5 mm below the value stated by the manufacturer.

Table 3 — Physical and chemical property requirements for luting materials
Requirement (subclause)
Film Working Setting time Depth of Water Solubility
a b
thickness time (5.2.5, 5.2.6) sorption (5.2.10)
cure
Material Class
(5.2.4) (5.2.10)
(5.2.2) (5.2.8)
3 3
s min
µm mm µg/mm µg/mm
minimum maximum
maximum minimum maximum maximum
Class 1 50 60 — 40 7,5
(5.2.5)
0,5 (opaquer)
Class 2 50 — — 40 7,5
1,5 (others)
Class 3 50 60 — 40 7,5
(5.2.6)
a
The determined value shall be no more than 10 µm above any value claimed by the manufacturer.

b
In any event, the values for all materials, with the exception of opaque luting materials, shall be no more than
0,5 mm below the value stated by the manufacturer.
6 Sampling
The test sample shall consist of packages prepared for retail sale from the same batch containing enough
material to carry out the specified tests, plus an allowance for repeat tests, if necessary.
NOTE 50 g should be sufficient.
7 Test methods
7.1 General reagent — Water
For the tests, use water prepared in accordance with ISO 3696 Grade 2.
ISO 4049:2009(E)
7.2 Test conditions
Unless specified otherwise by the manufacturer, prepare and test all specimens at (23 ± 1) °C. Control the
relative humidity to ensure that it remains greater than 30 % and less than 70 % at all times. If the material
was refrigerated for storage, allow it to attain (23 ± 1) °C.
For Class 3 materials, the tests for working time (see 7.6) and setting time (see 7.8) shall be performed in the
absence of activating radiation.
NOTE Ambient light, both natural and artificial, is capable of activating these materials. For good control, the test
2)
should be performed in a dark room with any artificial light filtered by a yellow filter.
7.3 Inspection
Inspect visually to check that requirements specified in Clause 8 have been met.
7.4 Preparation of test specimens
For the preparation of Class 2 and Class 3 materials, reference shall be made to the manufacturer’s
instructions [see 8.3 e)] 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 operating condition. [ISO 10650 (both
parts) gives guidance on this.]
Mix or otherwise prepare the material in accordance with the manufacturer’s instructions and the test
conditions specified in 7.2.
Where fully cured specimens are required for testing (7.11 to 7.14), it is important to ensure that the
specimens are homogeneous after removal from the mould. There shall be no clefts, voids, discontinuities or
air inclusions present when viewed without magnification.
Some polymer-based materials, particularly certain luting materials, have a chemical affinity for base metals.
This property creates difficulty when removing specimens from metal moulds. Reference shall be made to the
information supplied by the manufacturer [see 8.3 m)] regarding this property and, if it is claimed, moulds for
the preparation of specimens of such materials may be made from non-metallic material such as high-density
polyethylene.
7.5 Measurement of film thickness of luting materials
7.5.1 Apparatus
7.5.1.1 Two glass plates, optically flat, square or circular, each having a contact surface area of
(200 ± 25) mm . Each plate shall be of a uniform thickness not less than 5 mm.
7.5.1.2 Loading device, of the type illustrated in Figure 1, or an equivalent means, whereby a force of
(150 ± 2) N may be applied vertically to the specimen via the upper glass plate. In Figure 1, the anvil that is
attached to the bottom of the rod shall be horizontal and parallel to the base. The load shall be applied
smoothly and in such a manner that no rotation occurs.
NOTE A holder can be used to assist in the positioning of the plates. Such a device consists of a baseplate with three
vertical pins to align circular plates or four pins to align square plates. (See Figure 2.)
7.5.1.3 External energy source (for Class 2 and Class 3 materials), as recommended by the
manufacturer for use with the test material.

2) Polyester filter 101, Lee Filters, Andover, Hants, UK is an example of a suitable product available commercially. This
information is given for the convenience of the users of this International Standard and does not constitute an
endorsement of this product by ISO.
6 © ISO 2009 – All rights reserved

ISO 4049:2009(E)
7.5.1.4 Micrometer or equivalent measuring instrument, accurate to 0,001 mm.

Key
1 specimen
2 glass plates (7.5.1.1)
Figure 1 — Loading device for use in the film thickness test
7.5.2 Test procedure
7.5.2.1 Preliminary steps
Measure, to an accuracy of 0,001 mm, the combined thickness of the two optically flat glass plates (7.5.1.1)
stacked in contact with the micrometer (7.5.1.4) (reading A). Remove the upper plate and place between
0,02 ml and 0,10 ml of the test material treated in accordance with the manufacturer’s instructions in the
centre of the lower plate and centre it below the loading device (7.5.1.2) on its lower platen. Centre the second
glass plate on the test specimen in the same orientation as in the original measurement. The holder (Figure 2)
is helpful.
7.5.2.2 Class 1 materials
At (60 ± 2) s after mixing Class 1 materials, carefully apply a force of (150 ± 2) N vertically and centrally to the
specimen via the top plate for (180 ± 10) s. Ensure that the cement has completely filled the space between
the glass plates. At least 10 min after the commencement of mixing, remove the plates from the loading
device and measure the combined thickness of the two glass plates and the specimen film, again taking the
reading in the centre of the plates (reading B).
ISO 4049:2009(E)
Record the difference between reading A and reading B, to the nearest micrometre, as the film thickness of
the luting material.
Carry out five determinations.

NOTE 1 The diameter, d, slightly exceeds the diameter of the glass plates.
NOTE 2 The height, h, of the pins is 1,5 × the height of one of the glass plates.
Figure 2 — Holder to assist stabilisation of the glass plates (7.5)
7.5.2.3 Class 2 and Class 3 materials
Immediately after dispensing Class 2 materials or after mixing Class 3 materials, carefully apply a force of
(150 ± 2) N vertically and centrally to the specimen via the top plate for (180 ± 10) s. Ensure that the cement
has completely filled the space between the glass plates. After (180 ± 10) s, release the loading system and
irradiate the specimen through the centre of the upper glass plate for twice the recommended exposure time.
NOTE This irradiation is not intended to cure the material totally, but to stabilize the specimen for measurement.
After the irradiation of Class 2 and Class 3 materials, remove the plates from the loading device and measure
the combined thickness of the two glass plates and the specimen film, again taking the reading in the centre of
the plates (reading B).
Record the difference between reading A and reading B, to the nearest micrometre, as the film thickness of
the luting material.
Carry out five determinations.
7.5.3 Treatment of results
Record the film thickness and report as follows.
a) If at least four of the values are u 50 µm, the material is deemed to have complied with the second
requirement of 5.2.2.
b) If three or more values are > 50 µm, the material is deemed to have failed.
8 © ISO 2009 – All rights reserved

ISO 4049:2009(E)
c) If only three of the values are u 50 µm, repeat the whole test. If one or more of the values is > 50 µm on
the second occasion, the material is deemed to have failed the whole test.
d) If the manufacturer claims a specific value for film thickness, at least four of the five values shall be no
more than 10 µm greater than the claimed value in order to comply with the first requirement of 5.2.2.
7.6 Working time, Class 1 and Class 3 restorative materials, excluding luting materials
7.6.1 Apparatus
7.6.1.1 Thermocouple apparatus, as shown in Figure 3.
Dimensions in millimetres
Key
1 polyethylene tubing
2 polyamide block
3 stainless steel tube
4 thermocouple-cone of solder
Figure 3 — Apparatus for determination of working and setting times (7.6, 7.8)
The apparatus consists of a piece of high density polyethylene (or similar material) tubing (Key 1), located on
a block of polyamide or similar material, (Key 2), having a hole into which is inserted a stainless steel tube
(Key 3) containing a stabilized thermocouple (Key 4).
The tubing shall be 8 mm long, be 4 mm in internal diameter and have a wall thickness of 1 mm. The locating
part of the polyamide block shall be 4 mm in diameter and 2 mm high. When assembled, the two components
shall form a specimen well 6 mm high × 4 mm in diameter. In order to facilitate removal of the specimen after
testing, the thermocouple shall have a conical tip which protrudes 1 mm into the base of the specimen well.
The tolerances on the above-mentioned dimensions are ± 0,1 mm.
ISO 4049:2009(E)
The thermocouple shall consist of wires (0,20 ± 0,05) mm in diameter, made of a material
(e.g. copper/constantan) capable of registering temperature changes in a specimen of setting material to an
accuracy of 0,1 °C. The thermocouple is connected to an instrument (e.g. voltmeter or chart recorder) capable
of recording the temperature to that accuracy.
7.6.2 Procedure
Prepare the test material in accordance with the manufacturer’s instructions (see 8.3) and start timing from the
moment mixing is begun. Maintain the mould at (23 ± 1) °C and, 30 s after the start of mixing, place the mixed
material in the mould and record the temperature, T , of the material. Maintain the apparatus (7.6.1.1) at
(23 ± 1) °C and continuously record the temperature of the material until the maximum temperature is passed.
A typical recording trace is shown in Figure 4. As soon as the material is inserted into the mould, the
temperature will rise slightly to T and then fall until it becomes steady at T and then starts to increase. The
1 0
point at which the temperature begins to increase denotes the start of the setting reaction and, therefore, the
end of the working time. Determine this point by drawing a horizontal base line at (T ± 0,1) °C and recording
the working time, t , at the point of intersection with the trace. The results are extremely temperature-
w
dependent and slight variations within the permitted temperature range will cause variations of several
seconds. Record t from the start of mixing until the temperature starts to increase.
w
Carry out five determinations.

Key
X time
Y temperature
a
Start of mixing.
b
Insertion.
NOTE The schematic diagram shows the temperature at the time of insertion, T , the slight temperature increase
immediately after insertion, T , and the initial time of temperature increase which denotes the start of the setting reaction
and, therefore, the end of the working time, t .
w
Figure 4 — Determination of working time
10 © ISO 2009 – All rights reserved

ISO 4049:2009(E)
7.6.3 Treatment of results
Record the working times and report as follows.
a) If at least four of the times obtained are W 90 s, the material is deemed to have complied with the
requirement of 5.2.3.
b) If three or more of the times are < 90 s, the material is deemed to have failed.
c) If only three of the times are W 90 s, repeat the whole test. If one or more times are < 90 s on the second
occasion, the material is deemed to have failed the whole test.
7.7 Working time, Class 1 and Class 3 luting materials
7.7.1 Apparatus
7.7.1.1 Two glass microscope slides.
7.7.1.2 Timer, accurate to 1 s.
7.7.2 Procedure
At 60 s after the completion of mixing, place a spheroidal mass of approximately 30 mg of material on a glass
microscope slide (7.7.1.1) and immediately press the second microscope slide against the material using a
shearing action to produce a thin layer.
Visually inspect the material to see whether it is physically homogeneous.
NOTE During this test, if the material has begun to set, clefts and voids will appear in the specimen when the thin
layer is being produced. Alternatively, with rapid setting materials, there will be an increase in viscosity that will prevent the
layer being produced.
Repeat the entire procedure twice, using a new sample for each test. Record the results of all three tests.
7.7.3 Treatment of results
If, on visual inspection, the material of all three samples remains physically homogeneous and has formed a
thin layer, the material is deemed to have complied with the requirement of 5.2.4.
7.8 Setting time, Class 1 and Class 3 materials
7.8.1 Apparatus for the determination of setting time of Class 1 and Class 3 restorative materials
7.8.1.1 Thermocouple apparatus, as specified in 7.6.1.1.
7.8.2 Apparatus for the determination of setting time of Class 1 and Class 3 luting materials
7.8.2.1 Thermocouple apparatus, as specified in 7.6.1.1 except that the tubing shall be 6 mm long and
thus form a specimen well 4 mm in height. All other dimensions specified in 7.6.1.1 shall apply.
7.8.3 Procedure
Use the procedure specified in 7.6.2, but maintain the apparatus (7.8.1) at (37 ± 1) °C.
Measure the time from the start of mixing until a plateau at maximum temperature is reached. (See Figure 5.)
Extend the plateau backwards to meet an extension of the straight line of temperature increase. Record this
time, t , as the setting time.
s
ISO 4049:2009(E)
Perform the test five times.
7.8.4 Treatment of results
Record the setting times, referring to Table 2 or Table 3 for the particular material under test, and report as
follows.
a) If at least four of the times obtained are not more than the value specified in Table 2 or Table 3 for the
particular material, the material is deemed to have complied with the requirement of 5.2.5 or 5.2.6.
b) If three or more of the times are longer than the value specified in Table 2 or Table 3 for the particular
material, the material is deemed to have failed to comply with the requirement of 5.2.5 or 5.2.6.
c) If only three of the times are not more than the value specified in Table 2 or Table 3 for the particular
material, repeat the whole test. If one or more times are longer than the value specified in Table 2 or
Table 3 for the particular material, the material is deemed to have failed to comply with the requirement of
5.2.5 or 5.2.6.
Key
X time
Y temperature
a
Start of mixing.
NOTE The setting time, t , is determined by extending the plateau backwards to meet an extension of the straight
s
line of temperature increase. This provides a distinct datum point.
Figure 5 — Method for determining setting time
12 © ISO 2009 – All rights reserved

ISO 4049:2009(E)
7.9 Sensitivity to ambient light, Class 2 materials
7.9.1 Apparatus
7.9.1.1 Xenon lamp, or radiation source of equivalent performance (a suitable apparatus is described in
ISO 7491) with colour conversion and ultraviolet filters inserted.
3)
The colour conversion filter shall have an internal transmittance that matches to within ± 10 % of that shown
in Figure 6.
The ultraviolet filter shall be made of borosilicate glass with a transmittance < 1 % below 300 nm and > 90 %
above 370 nm.
The purpose of the filter is to convert the spectrum of the xenon radiation, or equivalent, to that approximating
to a dental operating light. The filters and the output of the light should be checked periodically to ensure that
the colour temperature at the luxmeter cell is 3 600 K to 6 500 K.
7.9.1.2 Two glass microscope slides/plates.
7.9.1.3 Illuminance-measuring device, e.g. luxmeter, capable of measuring illuminance of
(8 000 ± 1 000) lx.
7.9.1.4 Adjustable table.
Key
X wavelength, in nanometres
Y internal transmission, T
i
Figure 6 — Internal transmittance for colour conversion filter

3) The KR 12 filter supplied by Schott AG, Advanced Materials, Hüttenstr. 1, 31073 Grünenplan, Germany, website:
www.schott.com/advanced_materials is an example of a suitable product available commercially.This information is given
for the convenience of the users of this International Standard and does not constitute an endorsement of this product by
ISO.
ISO 4049:2009(E)
7.9.1.5 Matt black cover, for the luxmeter cell.
NOTE This is intended to prevent reflection from the cell interfering with the observation of the specimen.
7.9.1.6 Timer, accurate to 1 s.
7.9.2 Procedure
In a dark room, position the illuminance-measuring device cell (7.9.1.3) under the xenon lamp (7.9.1.1) with
colour conversion and ultraviolet filters inserted at such a height as to provide an illuminance of
(8 000 ± 1 000) lx. [The adjustable table (7.9.1.4) is required to do this efficiently.] Cover the cell with the matt
black cover (7.9.1.5). Place a spheroidal mass of approximately 30 mg of material on a glass microscope slide
(7.9.1.2), 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 material using
a shearing action to produce a thin layer.
Visually inspect the material to see whether it is physically homogeneous.
NOTE During this test, if the material has begun to set, discontinuities and voids will appear in the specimen when
the thin layer is being produced. It might 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 material for each test. Record the results of all three
tests.
7.9.3 Treatment of results
If, on visual inspection, the material of all three samples remains physically homogeneous, the material is
deemed to have complied with the requirement of 5.2.7.
7.10 Depth of cure, Class 2 materials
7.10.1 Apparatus
7.10.1.1 Stainless steel mould, for the preparation of a cylindrical specimen, 6 mm long and 4 mm in
diameter unless the manufacturer claims a depth of cure in excess of 3 mm; in this event, the mould shall be
at least 2 mm longer than twice the claimed depth of cure.
NOTE A mould release agent which does not interfere with the setting reaction, for example a 3 % solution of
polyvinyl ether wax in hexane, can be used to facilitate removal of the specimen.
7.10.1.2 Two glass slides/plates, each of sufficient area to cover one side of the mould.
NOTE Standard glass microscope slides can be used.
7.10.1.3 White filter paper.
7.10.1.4 Film, transparent to the activating radiation, (50 ± 30) µm thick, e.g. polyester.
7.10.1.5 External energy source, as recommended by the manufacturer for use with the test material
[see 8.3 e)].
7.10.1.6 Micrometer, accurate to 0,01 mm.
7.10.1.7 Plastics spatula.
14 © ISO 2009 – All rights reserved

ISO 4049:2009(E)
7.10.2 Procedure
Place the mould (7.10.1.1) on a strip of the transparent film (7.10.1.4) on a glass microscope slide (7.10.1.2).
Fill the mould with the test material, prepared in accordance with the manufacturer’s instructions, taking care
to exclude air bubbles. Slightly overfill the mould and put a second strip of the transparent film on top, followed
by the second m
...