EN ISO 9917-1:2003
(Main)Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2003)
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2003)
Migrated from Progress Sheet (TC Comment) (2000-07-10): draft BP: to be referenced to ISO/NP 9917-1. ISO?? (TA/990329)
Zahnheilkunde - Wasserhärtende Zemente - Teil 1: Zemente, die beim Vermischen von Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden (ISO 9917-1:2003)
Dieser Teil von ISO 9917 legt Anforderungen an und Prüfverfahren für zahnärztliche wasserhärtende Zemente fest, die beim Vermischen von Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden, und die für definitive Befestigungen, Unterfüllungen und Füllungen vorgesehen sind. Diese Norm gilt sowohl für Zemente zum Handmischen als auch für Zemente in Kapseln zum mechanischen Mischen. Diese Norm legt Grenzwerte für jede der Eigenschaften fest, je nachdem, ob der Zement für den Einsatz als Befestigungsmittel, als Unterfüllung oder als Füllungswerkstoff vorgesehen ist.
In diesem Teil von ISO 9917 werden keine besonderen qualitativen und quantitativen Anforderungen zum Ausschluss biologischer Risiken gestellt. Zur Beurteilung möglicher biologischer Risiken wird empfohlen, ISO 7405, Dentistry - Preclinical evaluation of biocompatibility of medical devices used in dentistry - Test methods for dental materials, und ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing heranzuziehen.
Art dentaire - Ciments à base d'eau - Partie 1: Ciments acido-basiques liquides/en poudre (ISO 9917-1:2003)
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-1:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9917-1:2004
01-februar-2004
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO
9917-1:2003)
Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements (ISO 9917-
1:2003)
Zahnheilkunde - Wasserhärtende Zemente - Teil 1: Zemente, die beim Vermischen von
Pulver und Flüssigkeit über eine Säure-Base-Reaktion abbinden (ISO 9917-1:2003)
Art dentaire - Ciments a base d'eau - Partie 1: Ciments acido-basiques liquides/en
poudre (ISO 9917-1:2003)
Ta slovenski standard je istoveten z: EN ISO 9917-1:2003
ICS:
11.060.10
SIST EN ISO 9917-1:2004 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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EUROPEAN STANDARD
EN ISO 9917-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
November 2003
ICS 11.060.10
English version
Dentistry - Water-based cements - Part 1: Powder/liquid acid-
base cements (ISO 9917-1:2003)
Art dentaire - Ciments à base d'eau - Partie 1: Ciments Zahnheilkunde - Wasserhärtende Zemente - Teil 1:
acido-basiques liquides/en poudre (ISO 9917-1:2003) Zemente, die beim Vermischen von Pulver und Flüssigkeit
über eine Säure-Base-Reaktion abbinden (ISO 9917-
1:2003)
This European Standard was approved by CEN on 3 October 2003.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 9917-1:2003 E
worldwide for CEN national Members.
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EN ISO 9917-1:2003 (E)
CORRECTED 2003-12-17
Foreword
This document (EN ISO 9917-1:2003) 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 May 2004, and conflicting national standards
shall be withdrawn at the latest by May 2004.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy,
Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and
the United Kingdom.
Endorsement notice
The text of ISO 9917-1:2003 has been approved by CEN as EN ISO 9917-1:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2
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EN ISO 9917-1:2003 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions of
any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated
by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 3696 1987 Water for analytical laboratory EN ISO 3696 1995
use – Specification and test
methods
ISO 7491 2000 Dental materials - Determination EN ISO 7491 2000
of colour stability
3
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INTERNATIONAL ISO
STANDARD 9917-1
First edition
2003-11-01
Dentistry — Water-based cements —
Part 1:
Powder/liquid acid-base cements
Art dentaire — Ciments à base d'eau —
Partie 1: Ciments acido-basiques liquides/en poudre
Reference number
ISO 9917-1:2003(E)
©
ISO 2003
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ISO 9917-1:2003(E)
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ii © ISO 2003 — All rights reserved
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ISO 9917-1:2003(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 1
4 Classification. 2
5 Material. 2
6 Preparation of test specimens. 3
7 Sampling. 3
8 Net setting time . 3
9 Film thickness (luting cements only). 3
10 Compressive strength. 3
11 Acid erosion. 4
12 Optical properties (polyalkenoate restorative cements only) . 4
13 Acid-soluble arsenic and lead contents . 4
14 Radiopacity. 4
15 Packaging, marking and information to be supplied by manufacturer. 4
Annex A (normative) Determination of net setting time. 7
Annex B (informative) Chemical compositions and applications of dental cements. 9
Annex C (normative) Determination of film thickness (luting cements only) . 10
Annex D (normative) Determination of compressive strength . 12
Annex E (normative) Determination of acid erosion . 14
Annex F (normative) Determination of optical properties (polyalkenoate restorative cements only) . 17
Annex G (normative) Determination of acid-soluble arsenic and lead contents. 20
Annex H (normative) Determination of radiopacity . 21
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ISO 9917-1:2003(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 9917-1 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 1, Filling and
restorative materials.
This part of ISO 9917 cancels and replaces ISO 9917:1991, which has been technically revised.
ISO 9917 consists of the following parts, under the general title Dental materials — Water-based cements:
Part 1: Powder/liquid acid-base cements
Part 2: Light-activated cements
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INTERNATIONAL STANDARD ISO 9917-1:2003(E)
Dentistry — Water-based cements —
Part 1:
Powder/liquid acid-base cements
1 Scope
This part of ISO 9917 specifies requirements and test methods for powder/liquid acid-base dental cements
intended for permanent cementation, lining and restoration. It is applicable to both hand-mixed cements and
encapsulated cements for mechanical mixing. It specifies limits for each of the properties according to whether
the cement is intended for use as a luting agent, a base or liner, or a restorative material.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this
part of ISO 9917, but it is recommended that, in assessing possible biological or toxicological hazards,
reference should be made to ISO 7405, Dentistry — Preclinical evaluation of biocompatibility of medical
deviced used in dentistry — Test methods for dental materials, and ISO 10993-1, Biological evaluation of
medical devices — Part 1: Evaluation and testing.
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 2590, General method for the determination of arsenic — Silver diethyldithiocarbamate photometric
method
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
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
mixing time
that part of the working time required in order to obtain a satisfactory mix of the components
3.2
working time
period of time, measured from the start of mixing, during which it is possible to manipulate a dental material
without an adverse effect on its properties
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ISO 9917-1:2003(E)
3.3
net setting time
period of time, measured from the end of mixing, until the material has set according to the criteria and
conditions specified in Annex A
NOTE For the purposes of this part of ISO 9917, in view of the wide variation in mixing times of cements, the net
setting time is determined from the end of mixing.
4 Classification
4.1 Chemical type
For the purposes of this part of ISO 9917, dental cements shall be classified on the basis of their chemical
composition, as follows:
a) zinc phosphate cement, see Clause B.1;
b) zinc polycarboxylate cement, see Clause B.2;
c) glass polyalkenoate cement, see Clause B.3.
Acid-base setting, water-based cements other than those listed above may fall within the scope of this part of
ISO 9917. If the manufacturer wishes to claim conformity for a particular product, the manufacturer shall
specify the type of material in accordance with 4.1 and 4.2 so that the correct performance limits are applied.
4.2 Application
For the purposes of this part of ISO 9917, materials shall be classified on the basis of their usage as follows:
a) luting cements;
b) bases or liners;
c) restorative cements.
5 Material
5.1 General
The cement shall consist of a powder and liquid which, when mixed in accordance with the manufacturer's
instructions, shall conform with the requirements in this clause and in Clauses 8 to 15.
5.2 Components
5.2.1 Liquid
For non-encapsulated cements, visually inspect the liquid. It shall be free from deposits or filaments on the
inside of its container. There shall be no visible signs of gelation.
5.2.2 Powder
For non-encapsulated cements, visually inspect the powder. It shall be free from extraneous material. If the
powder is coloured, the pigment shall be uniformly dispersed throughout the powder.
Encapsulated cements shall not be examined in this way.
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ISO 9917-1:2003(E)
5.3 Unset cement
The cement shall be mixed in accordance with Clause 6, and then visually inspected. It shall be homogeneous
and of a smooth consistency.
6 Preparation of test specimens
6.1 Ambient conditions
All specimens shall be prepared at a temperature of (23 ± 1) °C and a relative humidity of (50 ± 10) %.
6.2 Method of mixing
The cement shall be prepared in accordance with 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 may be required for certain
specimens.
7 Sampling
7.1 Hand-mixed cements
The sample, drawn from one batch, shall provide sufficient material to complete all the prescribed tests and
any necessary repeats.
NOTE Approximately 50 g of powder is necessary to complete the tests.
7.2 Encapsulated cements
The sample shall comprise a retail package of a sufficient number of capsules from one batch to complete all
the tests.
8 Net setting time
When determined in accordance with Annex A, the net setting time of the cement shall conform to relevant
requirements specified in Table 1.
9 Film thickness (luting cements only)
When determined in accordance with Annex C, the film thickness shall conform to relevant requirements
specified in Table 1.
10 Compressive strength
When determined in accordance with Annex D, the compressive strength of the cement shall conform to the
relevant requirements specified in Table 1.
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ISO 9917-1:2003(E)
11 Acid erosion
When determined in accordance with Annex E, the acid erosion of the cement shall conform to the relevant
requirements specified in Table 1.
12 Optical properties (polyalkenoate restorative cements only)
When prepared, stored and tested in accordance with Annex F, cements shall meet the following
requirements:
a) The opacity of the set restorative cement shall be within the limits specified in Table 1, unless the
restorative cement is designated as opaque by the manufacturer (see Clause 15).
b) The colour of the set cement shall match 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 [see
15.3.1 c)].
13 Acid-soluble arsenic and lead contents
13.1 Acid-soluble arsenic content
When determined in accordance with Annex G, the acid-soluble arsenic content shall not exceed the relevant
limits specified in Table 1.
13.2 Acid-soluble lead content
When determined in accordance with Annex G, the acid-soluble lead content shall not exceed the relevant
limits specified in Table 1.
14 Radiopacity
When the manufacturer describes the material as being radiopaque (see 15.2), the radiopacity shall be at
least equivalent to that of the same thickness of aluminium when determined in accordance with Annex H.
When the manufacturer claims a greater radiopacity, the measured value shall not be less than the value
claimed when determined in accordance with Annex H.
15 Packaging, marking and information to be supplied by manufacturer
NOTE Additional information may be included at the discretion of the manufacturer or as required by legislation.
15.1 Packaging
The materials shall be supplied in containers or capsules (for the purposes of this part of ISO 9917, the
container or capsule shall be considered to be the immediate wrapping of the material) that afford adequate
protection and have no adverse effect on the quality of the contents.
An outer pack may also be used to present the containers or capsules as a single unit.
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ISO 9917-1:2003(E)
15.2 Marking
Each outer container shall be clearly marked with the following details:
a) the name and/or trademark of the manufacturer and the trade name, type and application of the cement;
b) the shade of the powder according to the manufacturer's nominated shade guide;
c) the minimum net mass, in grams, of the powder or the minimum net volume, in millilitres, of the liquid, as
appropriate;
d) the manufacturer's batch or lot number;
e) on the outermost packaging, the recommended conditions of storage, and the “expiry date” for the
material under those conditions of storage;
f) if the cement is designated opaque, the outer packaging shall be clearly marked with this information;
g) if the cement is designated as radiopaque, the outer packaging shall be clearly marked with this
information;
h) each outer container of encapsulated cements shall be marked with the number of capsules in the
container, and the net mass in each capsule.
15.3 Manufacturer's instructions
15.3.1 General
Instructions shall accompany each package of the material and shall include the following:
a) the trade name of the product;
b) the manufacturer's name and contact details;
c) a shade guide or, when no shade guide is provided, details of a commercially available shade guide for
use with the material.
In addition, at least the information in 15.3.2 or 15.3.3, as appropriate, shall be given. For those materials not
mentioned specifically in 4.1, the manufacturer shall indicate the type of material (see 4.1 and 4.2) against
whose performance requirements the material shall be tested.
15.3.2 Hand-mixed cements
For hand-mixed cements, the following information shall be supplied:
a) the temperature range for preparation;
b) the recommended powder/liquid ratio, expressed as a mass/mass ratio for the recommended
temperature range, and an indication of how the user may achieve this ratio [also, for test purposes, the
powder/liquid ratio on a mass/mass basis to a precision of 0,01 g at a temperature of (23 ± 1) °C and a
relative humidity of (50 ± 10) %];
c) the type of mixing slab and spatula and their condition;
d) the rate of incorporation of the powder into the liquid;
e) the mixing time (see 3.1);
f) the working time (see 3.2);
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ISO 9917-1:2003(E)
g) the net setting time (see 3.3);
h) if appropriate, a statement recommending that a liner should be placed between the cement and the
dentine;
i) if appropriate, the minimum time at which finishing may be commenced and the recommended method of
finishing;
j) if appropriate, a statement indicating that the surface of the cement must be coated with a protective
coating and guidance on the type of coating to be used.
15.3.3 Encapsulated cements
For encapsulated cements, the following instructions shall be supplied:
a) the method of bringing about physical contact between the powder and liquid;
b) the type of mechanical mixing device and the mixing time to be employed;
c) the net setting time (see 3.3);
d) the working time (see 3.2);
e) if appropriate, a statement recommending that a liner should be placed between the cement and the
dentine;
f) if appropriate, the minimum time at which finishing may be commenced and the recommended method of
finishing;
g) the minimum deliverable volume, in millilitres, of mixed cement in one capsule;
h) if appropriate, a statement indicating that the surface of the cement must be coated with a protective
coating and guidance on the type of coating to be used.
Table 1 — Requirements for dental cements
Chemical Application Film Net setting Compressive Acid Opacity Acid- Acid-
type thickness time strength erosion C soluble soluble
0,70
As content Pb content
minutes
µm MPa mm mg/kg mg/kg
max. min. max. min. max. min. max. max. max.
Zinc phosphate Luting 25 2,5 8 50 0,30 2 100
Zinc Luting 25 2,5 8 50 0,40 2 100
polycarboxylate
Glass Luting 25 1,5 8 50 0,17 100
polyalkenoate
Zinc phosphate Base/liner 2 6 50 0,30 2 100
Zinc Base/liner 2 6 50 0,40 2 100
polycarboxylate
Glass Base/liner 1,5 6 50 0,17 100
polyalkenoate
Glass Restorative 1,5 6 100 0,17 0,35 0,90 100
polyalkenoate
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ISO 9917-1:2003(E)
Annex A
(normative)
Determination of net setting time
A.1 Apparatus
A.1.1 Cabinet, capable of being maintained at a temperature of (37 ± 1) °C and a relative humidity of at
least 90 %.
A.1.2 Indentor, of mass (400 ± 5) g, with a needle having a flat end of diameter (1,0 ± 0,1) mm which is
plane and perpendicular to the long axis of the needle.
A.1.3 Metal mould, similar to that shown in Figure A.1.
Dimensions in millimetres
Tolerance on dimensions: ± 0,15
NOTE Internal corners may be square or rounded.
Figure A.1 — Mould for preparation of specimens for determination of net setting time
A.1.4 Metal block, of minimum dimensions 8 mm × 75 mm × 100 mm, positioned within the cabinet and
maintained at (37 ± 1) °C.
A.1.5 Aluminium foil.
A.1.6 Timer, accurate to 1 s.
A.2 Procedure
Place the mould (A.1.3), conditioned to (23 ± 1) °C, on the aluminium foil (A.1.5) and fill to a level surface with
mixed cement.
60 s after the end of mixing, place the assembly, comprising mould, foil and cement specimen, on the block
(A.1.4), in the cabinet (A.1.1). Ensure good contact between the mould, foil and block.
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ISO 9917-1:2003(E)
90 s after end of mixing, carefully lower the indentor (A.1.2) vertically onto the surface of the cement and allow
it to remain there for 5 s. Carry out a trial run to determine the approximate setting time, repeating the
indentations at 30 s intervals until the needle fails to make a complete circular indentation in the cement, when
viewed using × 2 magnification. Clean the needle, if necessary, between indentations. Repeat the process,
starting the indentation at 30 s before the approximate setting time thus determined, making indentations at
10 s intervals.
Record the net setting time as the time elapsed between the end of mixing and the time when the needle fails
to make a complete circular indentation in the cement. Repeat the test two more times.
A.3 Expression of results
Record the results of the three tests. Each result shall fall within the range specified in Table 1 for the material
to meet the requirement.
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ISO 9917-1:2003(E)
Annex B
(informative)
Chemical compositions and applications of dental cements
B.1 Zinc phosphate cements
Zinc phosphate cements are based on the reaction between an oxide powder (the principal constituent of
which is zinc oxide) and an aqueous solution of phosphoric acid which may contain metal ions. They can be
used to cement dental appliances to hard oral structures or to other appliances. They can also be used as a
base for restorative materials and as a temporary restorative material.
B.2 Zinc polycarboxylate cements
Zinc polycarboxylate cements are based on the reaction between zinc oxide and aqueous solutions of
polyacrylic acid or similar polycarboxylic compounds, or zinc oxide/polycarboxylic acid powders which are
mixed with water. They can be used to cement dental appliances to hard oral structures or to other appliances.
They can also be used as a base for restorative materials and as a temporary restorative material.
B.3 Glass polyalkenoate cements
Glass polyalkenoate (glass ionomer) cements are based on the reaction between an aluminosilicate glass
powder and an aqueous solution of a polyalkenoic acid, or between an aluminosilicate glass/polyalkenoic acid
powder blend and water or an aqueous solution of tartaric acid. These cements are used for the aesthetic
restorations of teeth or as bases or liners for other restorations. They can also be used to cement dental
appliances to hard oral structures or to other appliances. This type also includes glass polyalkenoate cements
in which the glass and a metal have been fused (cermets) or mixed together and which are intended for the
restoration of teeth.
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ISO 9917-1:2003(E)
Annex C
(normative)
Determination of film thickness (luting cements only)
C.1 Apparatus
2
C.1.1 Two optically flat, square or circular glass plates, having a contact surface area of (200 ± 25) mm .
Each plate shall be of a uniform thickness of not less than 5 mm.
C.1.2 Loading device, of the type illustrated in Figure C.1, or an equivalent means, whereby a force of
(150 ± 2) N may be generated vertically to the specimen via the upper glass plate.
The anvil, which is attached to the bottom of the rod carrying the load, shall be horizontal and parallel to the
base. The device shall be such that the force is applied smoothly and in such a manner that no rotation occurs.
C.1.3 Screw micrometer or equivalent measuring instrument, having graduations of 2 µm or smaller.
Key
1 specimen
2 glass discs
Figure C.1 — Loading device for use in film thickness test
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ISO 9917-1:2003(E)
C.2 Procedure
Measure and record to an accuracy of 1 µm the combined thickness of the two optically flat glass plates
(C.1.1) stacked in contact and designate this measurement reading A. Remove the upper plate, place
(0,10 ± 0,05) ml of the mixed cement in the centre of the lower plate and place this centrally below the loading
device (C.1.2) on the lower platen. Replace the second glass plate centrally on t
...
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