SIST EN ISO 4049:2019
(Main)Dentistry - Polymer-based restorative materials (ISO 4049:2019)
Dentistry - Polymer-based restorative materials (ISO 4049:2019)
This document 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 the teeth and for luting.
The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506).
The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core materials or those used for veneering metal sub-frames (see ISO 10477).
Zahnheilkunde - Polymerbasierende Restaurationswerkstoffe (ISO 4049:2019)
Dieses Dokument legt Anforderungen an zahnärztliche polymerbasierende Restaurations¬werkstoffe fest, die in geeigneter Form zum mechanischen Mischen, Handmischen oder zur intraoralen und extraoralen äußeren Energieaktivierung vorgesehen sind und die hauptsächlich für direkte oder indirekte Restaurationen der Zähne und für Befestigungen vorgesehen sind.
Die polymerbasierenden Befestigungswerkstoffe, die in diesem Dokument beschrieben werden, sind für die Zementierung oder Befestigung von Restaurationen und Anwendungen wie Inlays, Onlays, Verblendungen, Kronen und Brücken vorgesehen. Dieses Dokument gilt nicht für polymerbasierende Befestigungswerkstoffe, die eine adhäsive Komponente in der Struktur des Werkstoffes aufweisen (siehe ISO/TS 16506).
Dieses Dokument ist nicht anwendbar für polymerbasierende Werkstoffe, die zur Kariesprophylaxe (siehe ISO 6874), als Kernwerkstoffe oder zur indirekten Verblendung von Metallgerüsten (siehe ISO 10477) vorgesehen sind.
Art dentaire - Produits de restauration à base de polymères (ISO 4049:2019)
Le présent document spécifie les exigences relatives aux produits dentaires de restauration à base de polymères fournis sous une forme convenant pour le mélange mécanique, manuel, ou à polymérisation intrabuccale et extrabuccale par énergie externe, et prévus en premier lieu pour être utilisés pour des restaurations directes ou indirectes des dents et pour des scellements.
Les produits de scellement à base de polymères couverts par le présent document sont prévus pour une utilisation dans le collage ou la fixation de restaurations et de dispositifs tels que les inlays, onlays, facettes, couronnes et ponts (bridges). Le présent document ne couvre pas les produits de scellement à base de polymères qui contiennent un composant adhésif dans la structure du produit (voir l'ISO/TS 16506).
Il ne traite pas des produits à base de polymères destinés à la prévention des caries (voir l'ISO 6874), des produits pour masse ou de ceux utilisés pour le revêtement des bases en métal (voir l'ISO 10477).
Zobozdravstvo - Materiali za obnovo zob na osnovi polimerov (ISO 4049:2019)
Ta dokument določa zahteve za materiale za obnovo zob na osnovi polimerov, ki so na voljo v obliki, primerni za mehansko mešanje, ročno mešanje ali za intra- ali ekstraoralno aktivacijo z zunanjo energijo, ter namenjene predvsem neposredni ali posredni obnovi zob oz. za tesnjenje. Materiali za tesnjenje na osnovi polimerov, zajeti v tem dokumentu, so namenjeni uporabi pri cementiranju ali pritrditvi obnov in pripomočkov, kot so indirektne zalivke (inlay, onlay), prevleke, krone in mostički. Ta dokument ne zajema materialov za tesnjenje na osnovi polimerov, ki imajo v strukturi materiala lepilno komponento (glej ISO/TS 16506).
Dokument ne zajema materialov na osnovi polimerov, namenjenih preprečevanju zobne gnilobe (glej ISO 6874), osnovnih materialov ali materialov, ki se uporabljajo za prekrivanje kovinskih pomožnih okvirov (glej ISO 10477).
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2019
Nadomešča:
SIST EN ISO 4049:2010
Zobozdravstvo - Materiali za obnovo zob na osnovi polimerov (ISO 4049:2019)
Dentistry - Polymer-based restorative materials (ISO 4049:2019)
Zahnheilkunde - Polymerbasierende Restaurationswerkstoffe (ISO 4049:2019)
Art dentaire - Produits de restauration à base de polymères (ISO 4049:2019)
Ta slovenski standard je istoveten z: EN ISO 4049:2019
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 4049
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2019
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 4049:2009
English Version
Dentistry - Polymer-based restorative materials (ISO
4049:2019)
Médecine bucco-dentaire - Produits de restauration à Zahnheilkunde - Polymerbasierende
base de polymères (ISO 4049:2019) Restaurationswerkstoffe (ISO 4049:2019)
This European Standard was approved by CEN on 18 May 2019.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4049:2019 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 4049:2019) 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 December 2019, and conflicting national standards
shall be withdrawn at the latest by December 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 4049:2009.
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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 4049:2019 has been approved by CEN as EN ISO 4049:2019 without any modification.
INTERNATIONAL ISO
STANDARD 4049
Fifth edition
2019-05
Dentistry — Polymer-based
restorative materials
Médecine bucco-dentaire — Produits de restauration à base de
polymères
Reference number
ISO 4049:2019(E)
©
ISO 2019
ISO 4049:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2019 – All rights reserved
ISO 4049:2019(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 Type . 2
4.2 Class . 2
5 Requirements . 2
5.1 Biocompatibility . 2
5.2 Physical and chemical properties . 2
5.2.1 General. 2
5.2.2 Film thickness, luting materials . 3
5.2.3 Working time, Class 1 and Class 3 restorative materials, excluding luting
materials . 3
5.2.4 Working time, Class 1 and Class 3 luting materials . 3
5.2.5 Setting time, Class 1 materials . 3
5.2.6 Setting time, Class 3 materials . 3
5.2.7 Sensitivity to light, Class 2 materials . 3
5.2.8 Depth of cure, Class 2 materials excluding luting materials . 3
5.2.9 Flexural strength . 4
5.2.10 Water sorption and solubility . 4
5.3 Shade of 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 . 5
7.3 Inspection . 6
7.4 Preparation of test specimens . 6
7.5 Measurement of film thickness of luting materials . 6
7.5.1 Apparatus . 6
7.5.2 Test procedure . 8
7.5.3 Treatment of results. 9
7.6 Working time, Class 1 and Class 3 restorative materials, excluding luting materials .10
7.6.1 Apparatus .10
7.6.2 Procedure .11
7.6.3 Treatment of results.11
7.7 Working time, Class 1 and Class 3 luting materials .12
7.7.1 Apparatus .12
7.7.2 Procedure .12
7.7.3 Treatment of results.12
7.8 Setting time, Class 1 and Class 3 materials .12
7.8.1 Apparatus for the determination of setting time of Class 1 and Class 3
restorative materials .12
7.8.2 Apparatus for the determination of setting time of Class 1 and Class 3
luting materials .12
7.8.3 Procedure .12
7.8.4 Treatment of results.13
7.9 Sensitivity to light, Class 2 materials .13
7.9.1 Apparatus .14
ISO 4049:2019(E)
7.9.2 Procedure .14
7.9.3 Treatment of results.15
7.10 Depth of cure, Class 2 materials excluding luting materials .15
7.10.1 Apparatus .15
7.10.2 Procedure .15
7.10.3 Treatment of results.16
7.11 Flexural strength .16
7.11.1 Apparatus .16
7.11.2 Preparation of test specimens .17
7.11.3 Procedure .18
7.11.4 Treatment of results.18
7.12 Water sorption and solubility .19
7.12.1 Apparatus .19
7.12.2 Preparation of test specimens .20
7.12.3 Procedure .21
7.12.4 Treatment of results.21
7.13 Shade and colour stability after irradiation and water sorption .22
7.13.1 General.22
7.13.2 Apparatus .22
7.13.3 Preparation of test specimens .23
7.13.4 Procedure .23
7.13.5 Colour comparison for shade .23
7.13.6 Colour comparison for colour stability .23
7.14 Radio-opacity .23
7.14.1 Perform the test in accordance with ISO 13116 .23
7.14.2 Preparation of test specimens .23
7.14.3 Treatment of results.23
8 Packaging, marking, instructions and information to be supplied by the manufacturer .24
8.1 Packaging .24
8.2 Marking and instructions for use .24
8.3 Declaration of components .28
Bibliography .29
iv © ISO 2019 – All rights reserved
ISO 4049:2019(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling
and restorative materials.
This fifth edition cancels and replaces the fourth edition (ISO 4049:2009), which has been technically
revised. The main changes compared to the previous edition are as follows:
— the test for sensitivity to ambient light has been changed because a filter used in the current test
was not available;
— the test for radio-opacity has been updated to refer to ISO 13116;
— luting materials no longer have to conform to the requirement for depth of cure;
— the manufacturer is now required to publish details of material composition, see Clause 8;
— several minor changes have been made to clarify content together with editorial changes.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/members .html.
ISO 4049:2019(E)
Introduction
Specific qualitative and quantitative requirements for freedom from biological hazard are not included
in this document. It is recommended, however, that reference should be made to ISO 10993-1 and
ISO 7405 when assessing possible biological or toxicological hazards.
vi © ISO 2019 – All rights reserved
INTERNATIONAL STANDARD ISO 4049:2019(E)
Dentistry — Polymer-based restorative materials
1 Scope
This document 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 the teeth and for luting.
The polymer-based luting materials covered by this document are intended for use in the cementation
or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This
document does not cover those polymer-based luting materials that have an adhesive component within
the structure of the material (see ISO/TS 16506).
The document does not cover polymer-based materials intended to prevent caries (see ISO 6874), core
materials or those used for veneering metal sub-frames (see ISO 10477).
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 7491:2000, Dental materials — Determination of colour stability
ISO 8601-1:2019, Date and time —Representations for information interchange Part — 1: Basic rules
ISO 8601-2:2019, Date and time —Representations for information interchange Part — 2: Extensions
ISO 13116:2014, Dentistry — Test method for determining radio-opacity of materials
ISO 17304:2013, Dentistry — Polymerization shrinkage: Method for determination of polymerization
shrinkage of polymer-based materials
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
opaque
shade of an intensely pigmented polymer-based restorative material of low translucency
3.2
outer pack
form of packaging used to combine a number of single dose containers or capsules
ISO 4049:2019(E)
3.3
outermost packaging
form of packaging used to combine material and additional items, including instructions for use and
any proportioning or mixing devices, that are supplied with the material
3.4
container
capsule
primary packaging of the material
4 Classification
4.1 Type
For the purposes of this document, dental polymer-based restorative materials are classified into the
following types.
— Type 1: Polymer-based restorative materials claimed by the manufacturer as suitable for
restorations involving occlusal surfaces;
— Type 2: All other polymer-based restorative materials, and luting materials.
4.2 Class
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 Table 4, items 9 and 20).
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 shall fulfil the requirements for both groups.
NOTE Class 2 luting materials 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
For guidance on biocompatibility see 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 the dental operating light
2 © ISO 2019 – All rights reserved
ISO 4049:2019(E)
(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 conform to the requirements both when used alone and when used with the maximum
recommended proportion of tint or blender (see Table 4, item 19). Depth of cure (5.2.8) of luting
materials shall not be tested.
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
materials shall be tested. This representative shade shall be either that classified by the manufacturer
as “Universal” or, in the event that no shade is so classified, that shade corresponding to “A3” in the
®1)
Vita classification of shade. However, if the manufacturer claims a higher value for radio-opacity (see
5.5 and Table 4, item 28) for any other shade, this claim shall be tested.
The requirements are summarized 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 no 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 no more than 5 min. The setting time for Class 1 luting materials, determined in
accordance with 7.8, shall be no 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 no more than 10 min.
5.2.7 Sensitivity to 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 excluding luting materials
When determined in accordance with 7.10, the depth of cure of Class 2 restorative materials shall be
no less than 1 mm if they are labelled by the manufacturer as opaque, or no less than 1,5 mm for other
restorative materials.
In any event, the values for all materials shall not be more than 0,5 mm below the value stated by the
manufacturer.
1) Vita® is a trade name of Vita Zahnfabrik, H Rauter GmbH & Co K G, Postfach 1338, D-79704 Bad Saeckingen,
Germany. This information is given for the convenience of the users of this document and does not constitute an
endorsement of this system by ISO.
ISO 4049:2019(E)
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.
Table 1 — Flexural strength
Flexural strength
Restorative materials
MPa minimum
Type 1 Class 1 80
Class 2, Group 1 80
Class 2, Group 2 100
Class 3 80
Type 2 Class 1 50
Class 2, Group 1 50
(including luting 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 equal to or less than 40 µg/mm .
b) the solubility of all materials shall be equal to or less than 7,5 µg/mm .
5.3 Shade of restorative materials
When the material is assessed in accordance with 7.13 and ISO 7491, the shade of the set material
shall closely match 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 conformance with this requirement (see Table 4, items 13 and 25). 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 when the material is 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 Table 4, items 16 and 28), 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 another shade or 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 Table 4, item 28).
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 2019 – All rights reserved
ISO 4049:2019(E)
Table 2 — Physical and chemical property requirements for restorative materials, excluding
luting materials
(see Table 1 for minimum flexural strength)
Requirement (subclause)
Water sorp-
a
Working time Setting time Depth of cure Solubility
tion
Material
(5.2.3) (5.2.5, 5.2.6) (5.2.8) (5.2.10) (5.2.10)
Class
3 3
s min mm µg/mm µg/mm
minimum maximum minimum maximum maximum
Class 1 90 5 — 40 7,5
(5.2.5)
Class 2 — — 1,0 (opaque shade) 40 7,5
1,5 (others)
Class 3 90 10 — 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)
Working
a
Film thickness Setting time Water sorption Solubility
time
Material Class
(5.2.2) (5.2.4) (5.2.5, 5.2.6) (5.2.10) (5.2.10)
3 3
µm s min µg/mm µg/mm
maximum minimum maximum maximum maximum
Class 1 50 60 10 40 7,5
(5.2.5)
Class 2 50 — — 40 7,5
Class 3 50 60 10 40 7,5
(5.2.6)
a
The determined value shall be no more than 10 µm above any value claimed 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. 50 g
should be sufficient.
7 Test methods
7.1 General reagent — Water
For the tests, use water prepared in accordance with ISO 3696:1987 Grade 2.
7.2 Test conditions
Unless otherwise specified by the manufacturer, prepare and test all specimens at (23 ± 2) °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 ± 2) °C before testing.
ISO 4049:2019(E)
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.
Ambient light, both natural and artificial, is capable of activating these materials. To control this, the
2)
test 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 Table 4, item 20) 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 (see ISO 10650 for guidance.)
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 Table 4, item 26) 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 no 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
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 document and does not constitute an endorsement
of this product by ISO. Alternatives are long-pass filters with a cut off above 525 nm.
6 © ISO 2019 – All rights reserved
ISO 4049:2019(E)
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.
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1 specimen
2 glass plates
Figure 1 — Loading device for use in the film thickness test (see 7.5)
A holder may 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).
ISO 4049:2019(E)
NOTE 1 The diameter, d, slightly exceeds the diameter of the glass plates.
NOTE 2 The height, h, of the pins is 1,5 times the height of one of the glass plates.
Figure 2 — Holder to assist stabilization of the glass plates (see 7.5)
7.5.1.3 External energy source (for Class 2 and Class 3 materials), as recommended by the
manufacturer for use with the material under test.
7.5.1.4 Micrometer or equivalent measuring instrument, accurate to 0,001 mm.
7.5.1.5 Timer accurate to 1 s.
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
stacked in contact with the micrometer (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 place this centrally below the loading device on its lower plate. Replace the second
glass plate centrally onto the test specimen in the same orientation as in the original measurement. The
holder (Figure 2) is helpful.
The volume of material needed to fill completely the space between the glass plates will vary according
to the material’s viscosity. A preliminary test may be used to determine the appropriate volume.
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).
Record the difference between reading A and reading B, to the nearest micrometre, as the film thickness
of the luting material.
8 © ISO 2019 – All rights reserved
ISO 4049:2019(E)
Carry out five determinations.
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. Immediately after the period of
loading 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 equal to or less than 50 µm, the material is deemed to have
conformed to the first requirement of 5.2.2.
b) If three or more values are greater than 50 µm, the material is deemed to have failed.
c) If only three of the values are equal to or less than 50 µm, repeat the whole test. If one or more of
the values is greater than 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 conform to the second requirement
of 5.2.2.
ISO 4049:2019(E)
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.
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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 (see 7.6, 7.8)
The apparatus consists of a piece of high-density polyethylene (or similar material) tubing, 1, located
on a block of polyamide or similar material, 2, having a hole into which is inserted a stainless-steel tube,
3, containing a stabilized thermocouple 4.
Tube 1 shall be 8 mm long, 4 mm in internal diameter and have a wall thickness of 1 mm. The locating
part of block 2 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 thermoc
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