SIST EN ISO 9917-2:2000
(Main)Dental water-based cements - Part 2: Light-activated cements (ISO 9917-2:1998)
Dental water-based cements - Part 2: Light-activated cements (ISO 9917-2:1998)
Migrated from Progress Sheet (TC Comment) (2000-07-10): Revision of EN 29917:1994.
Zahnärztliche wasserhärtende Zemente - Teil 2: Lichtaktivierte Zemente (ISO 9917-2:1998)
In diesem Teil von ISO 9917 werden die Anforderungen fu(r zahna(rztliche Zemente festgelegt einschließlich handgemischter Zemente in Kapselform zum mechanischen Mischen und Einkomponentenwerkstoffe, die als Basis, fu(r Fu(llungen und Ausbesserungen Verwendung finden, bei welchen die Werkstoffe auf Wasser basieren und der Abbindevorgang durch vielfache Reaktionen erfolgt, einschließlich der Reaktion auf Sa(urebasis und Polymerisierung.
Ciments dentaires hydrauliques - Partie 2: Ciments photo-activés (ISO 9917-2:1998)
Dental water-based cements - Part 2: Light-activated cements (ISO 9917-2:1998)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 9917-2:2000
01-julij-2000
Dental water-based cements - Part 2: Light-activated cements (ISO 9917-2:1998)
Dental water-based cements - Part 2: Light-activated cements (ISO 9917-2:1998)
Zahnärztliche wasserhärtende Zemente - Teil 2: Lichtaktivierte Zemente (ISO 9917-
2:1998)
Ciments dentaires hydrauliques - Partie 2: Ciments photo-activés (ISO 9917-2:1998)
Ta slovenski standard je istoveten z: EN ISO 9917-2:1999
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 9917-2:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 9917-2:2000
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SIST EN ISO 9917-2:2000
INTERNATIONAL ISO
STANDARD 9917-2
First edition
1998-07-01
Dental water-based cements —
Part 2:
Light-activated cements
Ciments dentaires hydrauliques —
Partie 2: Ciments photo-activés
A Reference number
ISO 9917-2:1998(E)
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SIST EN ISO 9917-2:2000
ISO 9917-2:1998(E)
Contents
1 Scope . 1
2 Normative references . 1
3 Definitions. 1
4 Classification. 2
5 Requirements . 2
6 Sampling . 3
7 Test methods. 3
7.1 Preparation of test specimens and test conditions. 3
7.2 Sensitivity to ambient light . 4
7.3 Setting time and initial hardening time. 5
7.4 Depth of cure. 6
7.5 Flexural Strength. 7
7.6 Radiopacity. 9
7.7 Opacity (restorative cements only) . 10
7.8 Shade and colour stability (restorative cements only). 11
8 Packaging, marking and information to be supplied by manufacturer . 12
Annex A Bibliography . 14
© ISO 1998
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced
or utilized in any form or by any means, electronic or mechanical, including photocopying and
microfilm, without permission in writing from the publisher.
International Organization for Standardization
Case postale 56 • CH-1211 Genève 20 • Switzerland
Internet central@iso.ch
X.400 c=ch; a=400net; p=iso; o=isocs; s=central
Printed in Switzerland
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SIST EN ISO 9917-2:2000
© ISO
ISO 9917-2:1998(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.
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.
International Standard ISO 9917-2 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 1, Filling and restorative materials.
ISO 9917 consists of the following parts, under the general title Dental water-based cements:
Part 1: (at present ISO 9917:1991)
Part 2: Light-activated cements.
Annex A of this part of ISO 9917 is for information only.
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ISO 9917-2:1998(E)
Introduction
This part of ISO 9917 has been prepared in order to present the requirements and test methods for water-based
cements in which setting is activated by an external radiation source. Some products which fall within the scope of
this part of ISO 9917 may also have a second mode of activation.
As far as possible, test methods employed within this part of ISO 9917 have been harmonized with those used in
ISO 4049 and ISO 9917:1991.
NOTE — Existing standard ISO 9917:1991 will become ISO 9917-1 on revision.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included in this part of
ISO 9917, but it is recommended that when assessing possible biological or toxicological hazards reference be
made to ISO 10993-1 and ISO 7405.
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SIST EN ISO 9917-2:2000
INTERNATIONAL STANDARD © ISO ISO 9917-2:1998(E)
Dental water-based cements —
Part 2:
Light-activated cements
1 Scope
This part of ISO 9917 specifies requirements for dental cements, including hand-mixed, encapsulated cements
used for mechanical mixing and one-component materials, which are intended for base, lining and restoration
purposes and for which the materials are water-based and set by multiple reactions which include 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 which 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 effect rapid setting through exposure to
a suitable source of radiation.
NOTE — Attention of manufacturers and test houses is drawn to the closely related International Standards ISO 4049 and
ISO 9917:1991. Consideration should be given as to the most appropriate International Standard by which to evaluate any
individual product.
2 Normative references
The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO
9917. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to
agreements based on this part of ISO 9917 are encouraged to investigate the possibility of applying the most recent
editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International
Standards.
ISO 3665:1996, Photography — Intra-oral dental radiographic film — Specification.
ISO 3696:1987, Water for analytical use — Specification and test methods.
ISO 7491:1985, Dental materials — Determination of colour stability of dental polymeric materials.
ISO 9917:1991, Dental water-based cements.
3 Definitions
For the purposes of this part of ISO 9917, the definitions given in ISO 9917:1991 and the following definitions apply.
3.1 setting time
Æin the absence of activating radiationæ period of time, measured from start of mixing, until the completion of set as
defined in 7.3.1.
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NOTE — In this part of ISO 9917, setting time is determined in the absence of activating radiation and is used to classify
products as type I or type II.
3.2 initial hardening time
Æin the absence of activating radiationæ period of time, measured from start of mixing, until a penetrator of given load
and dimensions is unable to penetrate to within 0,1 mm of the bottom of a sample of cement 5 mm thick, as
described in 7.3.2.
NOTE — In this part of ISO 9917 an estimate of working time is given by initial hardening time.
4 Classification
4.1 Clinical application
For the purposes of this part of ISO 9917, clinical application of these dental cements is classified as follows:
a) Bases and liners
b) Restorative cements
4.2 Setting reaction
For the purposes of this part of ISO 9917, these dental cements are classified on the basis of their setting
characteristics as follows:
a) Type I: Products that undergo setting by light activation but also set in the absence of activating light (see 5.4
and 7.3.1).
b) Type II: Products that set only after application of activating light (see 7.3.1).
5 Requirements
5.1 Material
The cement may consist of a number of components that, when treated in accordance with the manufacturer's
instructions, produces a material which will comply with the requirements of this part of ISO 9917.
When supplied as separate components for hand or mechanical mixing, the individual powder(s) and/or liquid(s) shall
be free from extraneous matter (see 7.1.2). There shall be no visible signs of gelation in liquid components (see 7.1.2).
5.2 Sensitivity to ambient light
When tested in accordance with 7.2, there shall be no detectable change in the homogeneity of any of the three
samples after being exposed to the test light for 30 s.
5.3 Setting time (in the absence of activating radiation)
When tested in accordance with 7.3, the setting time of type I materials in the absence of activating light shall be less
than 60 min.
5.4 Initial hardening time [in the absence of activating radiation (Type I materials only)]
When tested in accordance with 7.3, the initial hardening time (measured in the absence of activating light) shall not be
less than the value of the working time given by the manufacturer [see 8.3 f)].
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5.5 Depth of cure
When tested in accordance with 7.4, the depth of cure shall not be less than 1 mm. If the manufacturer claims a
greater depth of cure, the measured value shall not be more than 0,5 mm below the value stated by the
manufacturer.
5.6 Flexural strength
When tested in accordance with 7.5, the flexural strength shall not be less than 20 MPa for restorative cements or 10
MPa for bases and liners.
5.7 Radiopacity (if claimed)
If the manufacturer claims that the material is radiopaque [see 8.2 d)], the radiopacity, determined in accordance with
7.6, shall be at least the same as the equivalent thickness of aluminium and not more than 0,5 mm below the value
claimed by the manufacturer.
5.8 Opacity (restorative cements only)
When tested in accordance with 7.7, the cement shall have an opacity within the limits defined by the optical standards
(i.e. between 0,35 and 0,90). This requirement does not apply to cements designated as opaque by the manufacturer
[see 8.2 c)].
5.9 Shade and colour stability (restorative cements only)
When tested in accordance with 7.8, the shade of the material shall match closely that of the shade guide specified by
the manufacturer.
When tested in accordance with 7.8 and ISO 7491, there shall be no more than a slight change in colour after 7 days.
6 Sampling
A sample drawn from one batch shall provide sufficient material to complete all the prescribed tests and any necessary
repeats. The test sample shall consist of packages prepared for retail sale.
7 Test methods
7.1 Preparation of test specimens and test conditions
7.1.1 Test conditions
o
Unless specified otherwise by the manufacturer, prepare and test all specimens at a temperature of (23 ± 1) C. Control
the relative humidity to ensure that it remains greater than 30 % at all times. If the material was refrigerated for storage,
o
allow it to attain (23 ± 1) C.
Adequate provision shall be made for the exclusion of activating radiation when such conditions are required. Ambient
light, both natural and artificial, is capable of activating these materials. For good control, the test should be performed
in a dark room with any artificial light filtered by a yellow filter.
Water used in all tests specified in this part of ISO 9917 shall be prepared in accordance with ISO 3696 Grade 2.
7.1.2 Inspection requirements
Visual inspection shall be used in determining compliance with 5.1, 5.2, 5.8, 5.9 and clause 8.
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7.1.3 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, may be required for certain specimens.
Likewise, for materials supplied in single-dose containers, several containers may be required for each test specimen.
7.2 Sensitivity to ambient light
7.2.1 Apparatus
7.2.1.1 Xenon lamp or radiation source of equivalent performance (a suitable apparatus is described in ISO 7491)
1)
with colour-conversion and ultraviolet filters inserted. The colour-conversion filter shall be hardened glass 3 mm
thick and shall have an internal transmittance which matches within ±10% that shown in figure 1.
The ultraviolet filter shall be made of borosilicate glass with a transmittance of less than 1 % below 300 nm and greater
than 90 % above 370 nm.
NOTE — The purpose of the filter is to convert the spectrum of the xenon radiation, or equivalent, to that approximating a
dental operating light. The filters and the output of the light should be checked periodically to ensure that the colour
temperature at the luxmeter cell is 3600 K to 6500 K.
7.2.1.2 Two glass microscope slides/plates.
7.2.1.3 Illuminance-measuring device, e.g. luxmeter, capable of measuring illuminance of (8 000 ± 1 000) lx.
Figure 1 — Internal transmittance for colour conversion filter (see 7.2.1.1)
__________
1)
A suitable filter which corresponds to the internal transmittance shown in figure 1 and which is available commercially is the FG
15, hardened, rough-polished, 3 mm thick filter supplied by Schott Glaswerke, D-6500, Mainz 1, Germany. This information is given
for the convenience of the users of this part of ISO 9917 and does not constitute an endorsement of this product by ISO.
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7.2.1.4 Adjustable table.
7.2.1.5 Matt black cover for the luxmeter cell.
NOTE — This cover is intended to prevent reflection from the cell interfering with the observation of the experiment.
7.2.1.6 Timer, accurate to ± 1 s.
7.2.2 Procedure
In a dark room, position the illuminance-measuring device cell (7.2.1.3) under the xenon lamp with colour-conversion
and ultraviolet filters inserted (7.2.1.1) at such a height as to provide an illuminance of 8 000 lx. The adjustable table
(7.2.1.4) is needed to do this efficiently. Cover the cell with the black matt cover (7.2.1.5). Place 30 mg of material as a
spheroidal mass on a glass slide (7.2.1.2), position the slide on top of the cell and expose it to the light for 30 s.
Remove the slide with the sample from the irradiated area and immediately press the second microscope slide against
the material with a slight shearing action to produce a thin layer.
Visually inspect the material to see whether it is physically homogeneous. The whole procedure shall be repeated twice
using a new sample of material for each test. Record the results for all three tests.
NOTE — During this test, if the material has begun to set, clefts and voids will appear in the specimen when the thin layer is
being produced. It may help to compare the tested material with a sample which has not been exposed to any activating
radiation.
7.2.3 Treatment of results
If on visual inspection the material remains homogeneous for all three tests, the material is deemed to have satisfied
the requirements of 5.2.
7.3 Setting time and initial hardening time
7.3.1 Setting time, in the absence of activating radiation (Type I materials only)
7.3.1.1 Apparatus
o
7.3.1.1.1 Cabinet capable of being maintained at a temperature of (37 ± 1) C and a relative humidity of at least
90 %.
7.3.1.1.2 Indentor, of mass (400 ± 5) g and having a flat end of diameter (1 ± 0.1) mm. The needle tip shall be
cylindrical for approximately 5 mm. The needle end shall be plane and perpendicular to the long axis of the needle.
7.3.1.1.3 Metal mould similar to that shown in figure 2.
7.3.1.1.4 Metal block of minimum dimensions 8 mm x 75 mm x 100 mm positioned within the cabinet and
o
maintained at (37 ± 1) C.
Dimensions in millimetres
Tolerance on dimensions: ± 0,15
NOTE — Internal corners may be rounded.
Figure 2 — Mould for preparation of specimens for determination of working time and setting time
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7.3.1.1.5 Aluminium foil.
7.3.1.1.6 Timer, accurate to ± 1 s.
7.3.1.2 Procedure
NOTE — Material should be handled in the absence of light of wavelength 400 nm to 550 nm, e.g. using a dark room and/or
filtered light.
o
Place the mould (7.3.1.1.3), conditioned to (23 ± 1) C, on the aluminium foil (7.3.1.1.5) and fill to a level surface with
mixed cement.
At 60 s after end of mixing, place the assembly, comprising mould, foil and cement specimen, on the block (7.3.1.1.4)
in the cabinet (7.3.1.1.1). Ensure good contact between the mould, foil and block.
At 60 min after the end of mixing, carefully lower the indentor (7.3.1.1.2) vertically onto the surface of the cement. Allow
it to remain there for 5 s and note whether the needle fails to perceptibly sink into the sample. Repeat the indentation at
60 min 30 s and note whether the needle fails to perceptibly sink into the sample and whether the second probing gives
a result similar to the previous one (the definition of setting time in this test), when viewed using x2 magnification. Clean
the needle between indentations. Note whether the material had set after 60 min.
Repeat the test twice. Note whether the material has set at 60 min for each experiment.
7.3.1.3 Treatment of results
Record the results of the three tests. For Type I materials, all three samples shall be set at 60 min (see 5.3).
7.3.2 Initial hardening time [in the absence of activating radiation (Type I material
...
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