EN ISO 9917-2:2017

SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 9917-2:2010
Zobozdravstvo - Cementi na vodni osnovi - 2. del: Cementi z vsebnostjo smole
(ISO 9917-2:2017)
Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2017)
Zahnheilkunde - Wasserhärtende Zemente - Teil 2: Kunststoffmodifizierte Zemente (ISO
9917-2:2017)
Médecine bucco-dentaire - Ciments à base d'eau - Partie 2: Ciments modifiés par
addition de résine (ISO 9917-2:2017)
Ta slovenski standard je istoveten z: EN ISO 9917-2:2017
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 9917-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 9917-2:2010
English Version
Dentistry - Water-based cements - Part 2: Resin-modified
cements (ISO 9917-2:2017)
Médecine bucco-dentaire - Ciments à base d'eau - Zahnheilkunde - Wasserhärtende Zemente - Teil 2:
Partie 2: Ciments modifiés par addition de résine (ISO Kunststoffmodifizierte Zemente (ISO 9917-2:2017)
9917-2:2017)
This European Standard was approved by CEN on 1 July 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9917-2:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 9917-2:2017) 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 March 2018 and conflicting national standards shall be
withdrawn at the latest by March 2018.
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 9917-2:2010.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 9917-2:2017 has been approved by CEN as EN ISO 9917-2:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 9917-2
Third edition
2017-09
Dentistry — Water-based cements —
Part 2:
Resin-modified cements
Médecine bucco-dentaire — Ciments à base d’eau —
Partie 2: Ciments modifiés par addition de résine
Reference number
ISO 9917-2:2017(E)
©
ISO 2017
ISO 9917-2:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved

ISO 9917-2:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification and applications . 2
4.1 Classification . 2
4.2 Applications . 2
5 Requirements . 3
5.1 Materials . 3
5.2 Working time . 3
5.3 Setting time — Class 1 and Class 3 materials only . 3
5.4 Film thickness — Luting materials only (see 4.2) . 3
5.5 Flexural strength . 3
5.6 Radio-opacity . 3
5.7 Shade and colour stability — Restorative materials only . 3
6 Sampling . 3
7 Test conditions and preparation of test specimens . 4
7.1 Test conditions . 4
7.2 Method of mixing . 4
7.3 Inspection . 4
8 Packaging, marking and information to be supplied by the manufacturer .4
8.1 Packaging . 4
8.2 Marking and instructions for use . 5
Annex A (normative) Determination of working time and setting time . 8
Annex B (normative) Determination of film thickness — Luting materials only .10
Annex C (normative) Determination of flexural strength .12
Annex D (normative) Determination of radio-opacity .17
Annex E (normative) Determination of shade and colour stability — Restorative (except for
tooth core build-up) and luting materials only .19
Bibliography .21
ISO 9917-2:2017(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: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling
and restorative materials.
This third edition cancels and replaces the second edition (ISO 9917-2:2010), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— the adoption of ISO 13116 as the measuring procedure of the test method for radio-opacity;
— the inclusion of tooth core build-up as a restoration in the scope;
— the adoption of other minor technical revisions in the test methods.
A list of all parts of the ISO 9917 series can be found on the ISO website.
iv © ISO 2017 – All rights reserved

ISO 9917-2:2017(E)
Introduction
This document has been prepared in order to present the requirements and test methods for cements
in which setting is achieved by a combination of an acid-base reaction and polymerization. The
polymerization component of the reaction may be activated by mixing different components or through
application of energy from an external source. As far as possible, test methods employed within this
document have been harmonized with those used in ISO 4049 and ISO 9917-1.
No specific qualitative and quantitative requirements for ensuring the absence of biological hazard are
included in this document, but it is recommended that reference be made to ISO 10993-1 and ISO 7405
when assessing possible biological or toxicological hazards.
INTERNATIONAL STANDARD ISO 9917-2:2017(E)
Dentistry — Water-based cements —
Part 2:
Resin-modified cements
1 Scope
This document specifies requirements and test methods for water-based dental cements in which
setting is achieved by a combination of an acid-base reaction and polymerization. The materials are
intended for luting, base or lining, restoration and tooth core build up purposes.
EXAMPLE Conventional glass polyalkenoate cements are normally formed by reacting an ion-leachable
aluminosilicate glass with a polyalkenoic acid in an aqueous environment. Materials that fall within the scope of
this document will normally be able to effect setting by such an aqueous acid-base type reaction but in addition
will be able to undergo setting by polymerization.
NOTE The attention of manufacturers and test laboratories is drawn to the closely-related International
Standards ISO 4049 and ISO 9917-1 so that they can consider which is the most appropriate for evaluating any
individual product.
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, Water for analytical laboratory use — Specification and test methods
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 7491, Dental materials — Determination of colour stability
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO 13116:2014, Dentistry — Test method for determining radio-opacity of 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 http:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
mixing time
portion of the working time required in order to obtain a satisfactory mix of the components
Note 1 to entry: Materials that fall within the scope of this document include materials that require mixing and
single component materials that do not require mixing.
ISO 9917-2:2017(E)
[SOURCE: ISO 9917-1:2007, 3.1, modified — “that part of” has been replaced with “portion of” in the
definition, and note 1 to entry has been added.]
3.2
working time
period of time, measured from the start of mixing (if required), during which it is possible to manipulate
the material without an adverse effect on its properties
[SOURCE: ISO 9917-1:2007, 3.2 modified]
3.3
setting time
period of time, from the start of mixing, until the completion of setting, as defined by the ability of the
material to support an indenter under a known load, when the material needs to be mixed to set
3.4
outer pack
packaging used for single dose container(s)/capsule(s)
3.5
outermost packaging
packaging used to combine material and additional items, including instructions for use and any
proportioning or mixing devices that are supplied with the material
4 Classification and applications
4.1 Classification
For the purposes of this document, materials consist of water-based components which set by acid-base
reaction and polymer-based component(s) are classified on the basis of their setting characteristics of
polymer-based component(s) as follows:
— Class 1: materials setting of polymer-based components is activated following mixing of the
components of the material;
— Class 2: materials setting of polymer-based component(s) is activated by irradiation of light to the
mixed material;
— Class 3: materials setting of polymer-based components is activated following mixing of the
components and which can also be activated by irradiation of light to the mixed material.
4.2 Applications
For the purposes of this document, the clinical application of these materials is signified as follows:
a) luting;
b) base or lining;
c) restoration, including for tooth core build-up.
2 © ISO 2017 – All rights reserved

ISO 9917-2:2017(E)
5 Requirements
5.1 Materials
During the course of testing, there shall be no visible signs of extraneous matter in any component.
Separately supplied liquid shall be free of any gelation.
NOTE Gelation is the transition of a material from a fluid consistency to a state in which the material has
developed viscous or elastic properties. See ISO 14356:2003, 3.9.
5.2 Working time
When tested in accordance with Annex A, the working time shall comply with the requirements given
in Table 1 and shall be at least as long as the value given by the manufacturer (see Table 2, item 22).
5.3 Setting time — Class 1 and Class 3 materials only
When tested in accordance with Annex A, the setting time of Class 1 and Class 3 materials shall comply
with the requirements given in Table 1 and shall be no longer than the value given by the manufacturer
(see Table 2, item 23).
5.4 Film thickness — Luting materials only (see 4.2)
The film thickness of luting materials when determined in accordance with Annex B, shall be no more
than 5 µm above any value claimed by the manufacturer (i.e. the first requirement) and in any event
shall comply with the requirements given in Table 1 (i.e. the second requirement).
5.5 Flexural strength
When tested in accordance with Annex C, the flexural strength shall comply with the requirements
given in Table 1.
5.6 Radio-opacity
If the manufacturer claims that the material is radio-opaque (see Table 2, item 14), the radio-opacity,
determined in accordance with Annex D and ISO 13116:2014, 7.3 or 7.4, shall be equal to or greater than
that of the same thickness of aluminium. If greater radio-opacity is stated by the manufacturer, it shall
not be less than the value stated by the manufacturer (see Table 2, item 15).
5.7 Shade and colour stability — Restorative materials only
When tested in accordance with Annex E, the set material shall closely match that of the shade guide
specified by the manufacturer. When tested in accordance with Annex E and ISO 7491, there shall be no
more than a slight change in colour after 7 d.
6 Sampling
A sample drawn from one batch shall provide sufficient material to complete all the prescribed tests
plus an allowance for any repeat tests, should they become necessary. The test sample shall consist of
packages prepared for retail sale.
ISO 9917-2:2017(E)
Table 1 — Requirements for dental cements
a b c
Film thickness Working time Setting time Flexural strength
Application
µm min min MPa
Max. Min. Max. Min.
Luting 25 1,5 8 10
Base or lining — 1,5 6 10
Restoration — 1,5 6 25
a
The determined value shall be no more than 5 μm above any value claimed by the manufacturer.
b
Class 2 and Class 3 materials tested without activation by light.
c
Class 1 and Class 3 materials only. Class 3 materials tested without activation by light.
7 Test conditions and preparation of test specimens
7.1 Test conditions
Prepare and test all specimens at an ambient temperature of (23 ± 2) °C. Control the relative humidity
to ensure that it remains at (50 ± 20) % at all times. If the material was refrigerated for storage, allow
it to reach (23 ± 2) °C before testing. Test equipment shall be maintained at the condition specified in
individual tests.
For Class 2 and Class 3 materials, activating radiation shall be excluded during the determination of
working time.
Water used in all tests specified in this document shall be prepared in accordance with ISO 3696,
grade 2.
For Class 2 and Class 3 materials, refer to the manufacturer’s instructions (see Table 2, item 24),
which state the external energy source to be used. Ensure that the source is in a satisfactory working
condition.
7.2 Method of mixing
The cement shall be prepared according to the manufacturer’s instructions. Sufficient cement shall be
mixed to ensure that the preparation of each specimen is completed from one mix. A fresh mix shall be
prepared for each specimen.
NOTE For encapsulated materials, more than one capsule, simultaneously mixed, might be required for
certain specimens. Likewise, for materials supplied in single dose containers, several containers might be
required for each test specimen.
7.3 Inspection
Visual inspection shall be used in determining compliance with 5.1 and Clause 8.
8 Packaging, marking and information to be supplied by the manufacturer
8.1 Packaging
The components of the material shall be supplied in properly sealed containers which adequately
protect their contents and have no adverse effect on the quality of the product.
4 © ISO 2017 – All rights reserved

ISO 9917-2:2017(E)
An outer pack may be used to present the individual containers as a single unit or for marking of a
single dose capsule, syringe or bottle.
NOTE Single paste and powder-liquid encapsulated products can be sold as a pack containing many unit
doses of material.
8.2 Marking and instructions for use
Information shall be clearly marked on the outermost packaging or containers (for multi-dose packs or
capsules), as appropriate, and as indicated in Table 2.
Instructions shall accompany each package of the material and shall include the information
appropriate to the material (see Clause 4), as indicated in Table 2, where “M” means mandatory, “OPT”
means optional, and “NA” not applicable.
Information additional to that specified in Table 2 may be supplied at the discretion of the manufacturer.
Regulations might also require additional information to be supplied.
NOTE Table 2 contains several optional references and serves as a guide to the manufacturer as to the sort
of information which might be useful to dentists.
Table 2 — Requirements for marking and instructions for use
Capsules,
Outer
Outermost
syringes or Manufacturer’s
pack of
packaging
Items of marking and instructions for use bottles instruction
capsule(s)
(of leaflet
see 3.5
see 3.4
single-dose)
1 The name of the product M M NA M
2 The identification or name of the manufacturer M M OPT M
The address of the manufacturer or the agent
3 M OPT NA M
responsible for sale
4 URL OPT OPT NA OPT
5 The recommended conditions of storage M OPT NA M
6 The manufacturer’s batch number M M OPT NA
The expiry date, expressed in accordance with
7 ISO 8601, for the cement when stored under the M M OPT NA
manufacturer’s recommended conditions
8 The classification of the cement (see 4.1) M OPT OPT M
9 The clinical application (see 4.2) OPT OPT NA M
The number of containers/capsules, for capsule
10 M M NA NA
or cartridge cements
11 The net mass in each container/capsule OPT M OPT OPT
Shade and/or colour of the cement according to
12 the manufacturer’s nominated shade guide (for OPT M OPT OPT
multi-shade materials only)
If the material is designated opaque, a clear state-
13 M OPT OPT M
a
ment to this effect
If the cement is designated radio-opaque (see
14 OPT OPT
...