SIST EN ISO 9917-2:2010
(Main)Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2010)
Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2010)
This part of ISO 9917 specifies requirements and test methods for dental cements that are intended for luting, base or lining and restoration purposes and for which the materials are water-based and set by multiple reactions in which setting is achieved by a combination of an acid-base reaction and polymerization.
Zahnheilkunde - Wasserhärtende Zemente - Teil 2: Kunststoffmodifizierte Zemente (ISO 9917-2:2010)
Diese Internationale Norm legt Anforderungen und Prüfverfahren für zahnärztliche Zemente fest, die für Befestigungen, Unterfüllungen oder Füllungen verwendet werden und bei denen die Zemente Wasser enthalten und durch mehrere Reaktionen abbinden, wobei die Härtung über die Kombination einer Säure-Base-Reaktion mit einer Polymerisation erfolgt.
BEISPIEL Konventionelle Glas-Polyalkenoat-Zemente (Glasionomerzemente) werden im Allgemeinen durch eine Reaktion von ionenlöslichem Aluminiumsilikatglas mit einer polyalkenhaltigen Säure in wässriger Umgebung hergestellt. Bei den Zementen, die in den Anwendungsbereich dieser Norm fallen, erfolgt die Härtung üblicherweise durch solch eine wässrige Säure-Base-Reaktion, zusätzlich erfolgt jedoch eine Abbindung durch Polymerisation.
ANMERKUNG Für Hersteller und Prüfinstitute wird auf die folgenden Normen hingewiesen, die eng mit dieser Norm verbunden sind. Für die Bewertung eines einzelnen Produktes sollte die Internationale Norm verwendet werden, die dafür am besten geeignet ist..
ISO ISO 4049:2000, Dentistry — Polymer-based filling, restorative and luting materials
ISO ISO 9917-1:2003, Dentistry — Water-based cements — Part 1: Powder/liquid acid-base cements
Art dentaire - Ciments dentaires hydrauliques - Partie 2: Ciments modifiés résineux (ISO 9917-2:2010)
L'ISO 9917-2:2010 spécifie les exigences et les méthodes d'essai relatives aux ciments dentaires destinés à être utilisés pour scellement, fond de cavité, revêtement ou scellement et restauration. Les matériaux utilisés sont aqueux et leur prise est provoquée par de multiples réactions. La prise est obtenue par une association d'une réaction acido-basique et de la polymérisation.
Zobozdravstvo - Cementi na vodni osnovi - 2. del: Cementi z vsebnostjo smole (ISO 9917-2:2010)
Ta del ISO 9917 določa zahteve in preskusne metode za dentalne cemente, namenjene za tesnitev, osnovo ali oblogo ter obnovo, z materiali na vodni osnovi, ki se strjujejo z več reakcijami s kombinacijo kislinsko-bazičnih reakcij in polimerizacije.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9917-2:2010
01-junij-2010
1DGRPHãþD
SIST EN ISO 9917-2:2000
Zobozdravstvo - Cementi na vodni osnovi - 2. del: Cementi z vsebnostjo smole
(ISO 9917-2:2010)
Dentistry - Water-based cements - Part 2: Resin-modified cements (ISO 9917-2:2010)
Zahnheilkunde - Wasserhärtende Zemente - Teil 2: Kunststoffmodifizierte Zemente (ISO
9917-2:2010)
Art dentaire - Ciments dentaires hydrauliques - Partie 2: Ciments modifiés résineux (ISO
9917-2:2010)
Ta slovenski standard je istoveten z: EN ISO 9917-2:2010
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 9917-2:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9917-2:2010
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SIST EN ISO 9917-2:2010
EUROPEAN STANDARD
EN ISO 9917-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2010
ICS 11.060.10 Supersedes EN ISO 9917-2:1999
English Version
Dentistry - Water-based cements - Part 2: Resin-modified
cements (ISO 9917-2:2010)
Médecine bucco-dentaire - Ciments à base d'eau - Partie 2: Zahnheilkunde - Wasserhärtende Zemente - Teil 2:
Ciments modifiés par addition de résine (ISO 9917-2:2010) Kunststoffmodifizierte Zemente (ISO 9917-2:2010)
This European Standard was approved by CEN on 15 March 2010.
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, Croatia, 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
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9917-2:2010: E
worldwide for CEN national Members.
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SIST EN ISO 9917-2:2010
EN ISO 9917-2:2010 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 9917-2:2010
EN ISO 9917-2:2010 (E)
Foreword
This document (EN ISO 9917-2:2010) 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 October 2010, and conflicting national standards shall be withdrawn at
the latest by October 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 9917-2:1999.
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, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 9917-2:2010 has been approved by CEN as a EN ISO 9917-2:2010 without any modification.
3
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SIST EN ISO 9917-2:2010
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SIST EN ISO 9917-2:2010
INTERNATIONAL ISO
STANDARD 9917-2
Second edition
2010-04-15
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 9917-2:2010(E)
©
ISO 2010
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
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ii © ISO 2010 – All rights reserved
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(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.2
5.1 Materials .2
5.2 Working time.3
5.3 Setting time — Classes 1 and 3 materials only.3
5.4 Film thickness — Luting cements only.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 requirements.4
8 Packaging, marking and information to be supplied by the manufacturer.4
8.1 Packaging.4
8.2 Marking and instructions for use.4
Annex A (normative) Determination of working time and setting time.7
Annex B (normative) Determination of film thickness — Luting materials only.9
Annex C (normative) Determination of flexural strength.11
Annex D (normative) Determination of radio-opacity .15
Annex E (normative) Determination of shade and colour stability — Restorative and luting
materials only .18
Bibliography.19
© ISO 2010 – All rights reserved iii
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(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 9917-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This second edition cancels and replaces the first edition (ISO 9917-2:1998), which has been technically
revised by the inclusion of resin-modified cements which set by both chemically activated and light-activated
polymerization.
ISO 9917 consists of the following parts, under the general title Dentistry — Water-based cements:
⎯ Part 1: Powder/liquid acid-base cements
⎯ Part 2: Resin-modified cements
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
Introduction
This part of ISO 9917 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 part of ISO 9917 have been
harmonized with those used in ISO 4049 and ISO 9917-1.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
part of ISO 9917, but it is recommended that reference be made to ISO 10993-1 and ISO 7405 when
assessing possible biological or toxicological hazards.
© ISO 2010 – All rights reserved v
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SIST EN ISO 9917-2:2010
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SIST EN ISO 9917-2:2010
INTERNATIONAL STANDARD ISO 9917-2:2010(E)
Dentistry — Water-based cements —
Part 2:
Resin-modified cements
1 Scope
This part of ISO 9917 specifies requirements and test methods for dental cements that are intended for luting,
base or lining and restoration purposes and for which the materials are water-based and set by multiple
reactions in which setting is achieved by a combination of an acid-base reaction and polymerization.
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 part of
ISO 9917 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 Attention of manufacturers and test laboratories is drawn to the closely-related International Standards
ISO 4049 and ISO 9917-1. Consideration should be given as to which is the most appropriate International Standard by
which to evaluate any individual product.
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 3665:1996, 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
mixing time
that part of the working time required in order to obtain a satisfactory mix of the components
NOTE Materials that fall within the scope of this part of ISO 9917 include materials that require mixing and single
component materials that do not require mixing.
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
3.2
working time
period of time, measured from start of mixing (if required), during which it is possible to manipulate the
material without an adverse effect on its properties
NOTE Working time is determined in the absence of activating radiation, if required for activation for Class 3
materials (see Clause 4).
3.3
setting time
period of time, from start of mix, until the completion of set, as defined by the ability of the material to support
an indenter under a known load
3.4
outer pack
form of packaging used to combine a number of single dose containers or capsules
3.5
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
4 Classification and applications
4.1 Classification
For the purposes of this part of ISO 9917, materials are classified on the basis of their setting characteristics
as follows.
⎯ Class 1: materials in which the setting reaction of the polymerizable component is activated chemically
following mixing of components.
⎯ Class 2: materials in which the setting reaction of the polymerizable component is light-activated.
⎯ Class 3: materials in which the setting reaction of the polymerizable component is activated chemically
following mixing of components and may also be light-activated.
4.2 Applications
For the purposes of this part of ISO 9917, the clinical application of these materials is signified as follows:
a) luting;
b) base or lining;
c) restoration.
5 Requirements
5.1 Materials
During the course of testing, there shall be no visible signs of extraneous matter in any component and
separately supplied liquid shall be free of any gelation.
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
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 24).
5.3 Setting time — Classes 1 and 3 materials only
When tested in accordance with Annex A, the setting time of Classes 1 and 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 25).
5.4 Film thickness — Luting cements only (see 4.2)
When tested in accordance with Annex B, the film thickness of luting materials shall comply with the
requirements given in Table 1.
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 16), the radio-opacity,
determined in accordance with Annex D, shall be equal to or greater than that of the same thickness of
aluminium. If greater radio-opacity is claimed, it shall not be less than 0,5 mm below the value claimed by the
manufacturer (see Table 2, item 17).
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.
Table 1 — Requirements for dental cements
a
Film thickness Working time Setting time Flexural strength
Application µm min MPa
min
Max. Min. Max. Min.
Luting 25 1,5 8 10
Base or lining — 1,5 6 10
Restoration — 1,5 6 25
a
Class 1 and 3 materials only. Class 3 materials tested without activation by light.
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.
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
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. Test equipment should be maintained at the condition specified in individual tests.
For Classes 2 and 3 materials, activating radiation shall be excluded during the determination of working time.
Water used in all tests specified in this part of ISO 9917 shall be prepared in accordance with ISO 3696,
grade 2.
For Classes 2 and 3 materials, reference shall be made according to the manufacturer's instructions (see
Table 2, item 26), which state the external energy source to be used. Care shall be taken to 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 requirements
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.
An outer pack may be used to present the individual containers as a single unit.
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.
Information additional to that specified in Table 2 may be supplied at the discretion of the manufacturer.
NOTE Some information is indicated as mandatory and other as optional. The symbol “/ ” indicates that this item is
either irrelevant or optional for the product. 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.
4 © ISO 2010 – All rights reserved
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
Table 2 — Requirements for marking and instructions for use
Capsule
Outermost Outer pack
Manufacturer's
(single-dose),
packaging of capsules
Requirement instruction
syringes or
leaflet
see 3.5 see 3.4
bottles
a b
1 The name of the product. M M
/ M
2 The identification or name of the manufacturer. M M / M
The address of the manufacturer or the agent
3 M / / M
responsible for sale.
4 URL. / / / /
5 Information required by local/national legislation. M M / M
6 The recommended conditions of storage. M / / M
7 The manufacturer's batch number. M M / /
The expiry date, expressed in accordance with
8 ISO 8601, for the cement when stored under the M M / /
manufacturer's recommended conditions.
9 The shelf life under those conditions of storage. / / / /
10 The classification of the cement (see 4.1). M / / /
11 The clinical application (see 4.2). / / / M
The number of containers/capsules, for capsule or
12 M M / /
cartridge cements.
13 The net mass in each container/capsule. / M / M
Shade and/or colour of the cement according to the
c
14 manufacturer's nominated shade guide (for multi- / M M /
shade materials only).
If the material is designated opaque, a clear
15 M / / M
d
statement to this effect .
If the cement is designated radio-opaque (see 5.6), a
16 / / / M
clear statement to this effect.
If a specific claim on the extent of radio-opacity is
17 made, the equivalent thickness of aluminium for / / / M
1 mm thickness of the cement (see 5.6).
The recommended ratio of components
(e.g. powder:liquid) and instructions for use of any
18 proportioning aids (e.g. scoops, etc.) and the / / / M
proportions on a mass/mass basis to a precision of
0,1 g (for hand mixed materials only).
The rate of incorporation of the powder into the liquid
19 / / / M
(for hand-mixed materials only).
20 The mixing time (see 3.1), if mixing required. / / / M
The mixing condition (if appropriate, the condition
21 and type of the mixing slab and spatula). For / / / M
hand-mixed materials only.
For encapsulated cements, the method of bringing
22 about physical contact between the components, if / / / M
required.
The method, timing and type of mechanical mixing, if
23 / / / M
required.
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
Table 2 (continued)
Capsule
Outermost Outer pack
Manufacturer's
(single-dose),
packaging of capsules
Requirement instruction
syringes or
leaflet
see 3.5 see 3.4
bottles
24 The working time (see 3.2). / / / M
The setting time (for class 1 and 3 materials only,
25 / / / M
see 3.3).
The recommended external energy source(s),
26 exposure times and any special instructions for use / / / M
of the equipment (for class 2 and 3 materials only).
The maximum thickness of layer for polymerization
27 [class 2 and 3 materials for application b) and c) / / / M
only].
The minimum time at which finishing and polishing
28 / / / M
may be commenced (for restoration only, see 4.2).
The recommended method of finishing (for
29 / / / /
restoration only, see 4.2).
30 The necessity of varnish, if appropriate. / / / /
The precautions necessary to prevent premature
31 / / / M
activation of setting (class 2 and 3 cements only).
a
“/” indicates no relevance for this combination of container/marking/instructions or that such a requirement would be impracticable
or impossible or that the information may be informative but optional.
b
“M” indicates that an item is mandatory.
c
For individual/small dose containers, the individual containers shall have some means of identifying the colour/shade of the
material either directly or through reference to a key or guide in the instruction leaflet.
d
Opaque designation can be included in the shade.
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
Annex A
(normative)
Determination of working time and setting time
A.1 Apparatus
A.1.1 Test environment, capable of being maintained at a temperature of (37 ± 1) °C and a relative
humidity of at least 50 %.
A.1.2 Indenter, of a given mass and having a flat end with a given diameter. The tip shall be cylindrical for
approximately 5 mm. The indenter end shall be plane and perpendicular to its long axis.
A.1.2.1 Indenter for working time, of mass: (28,00 ± 0,25) g and diameter: (2,0 ± 0,1) mm.
A.1.2.2 Indenter for setting time, of mass: (400 ± 5) g and diameter: (1,0 ± 0,1) mm.
A.1.3 Metal mould, of thickness (5 ± 2) mm having a circular or square hole of (10 ± 2) mm diameter/length
2
cut in a sheet of metal at least 16 mm .
NOTE Internal corners of a square hole can be rounded.
3
A.1.4 Metal block, with a thickness of at least 8 mm and a volume of at least 60 cm .
A.1.5 Aluminium foil.
A.1.6 Timer, capable of reading to 1 s.
A.2 Determination of working time
A.2.1 Procedure
Classes 2 and 3 materials should be handled in the absence of light of wavelength 400 nm to 500 nm, for
example using a dark room and/or filtered light.
The test shall be performed under the conditions described in 7.1.
Place the mould (A.1.3), conditioned to (23 ± 1) °C, on the block (A.1.4) covered with the aluminium foil
(A.1.5), also conditioned to (23 ± 1) °C, and fill to a level surface with mixed cement.
Ten seconds before the end of the working time given by the manufacturer (see Table 2, item 24) or the
minimum value given in Table 1 (whichever is the longer), carefully lower the indenter (A.1.2.1) vertically on to
the surface of the cement and allow it to remain there for 5 s. Note whether the indenter makes a complete
circular indentation in the surface of the cement.
Repeat the test with two separate mixes of the material.
A.2.2 Treatment of results
In order to satisfy the requirements, the indenter shall make a complete circular indentation in the surface of
the cement specimen. All three values of indentation shall comply at 10 s before the working time stated by
the manufacturer (see Table 2, item 24) and with the minimum value of working time in Table 1.
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SIST EN ISO 9917-2:2010
ISO 9917-2:2010(E)
A.3 Determination of setting time — Class 1 and 3 materials only
...
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