SIST EN ISO 4823:2001
(Main)Dentistry - Elastomeric impression materials (ISO 4823:2000)
Dentistry - Elastomeric impression materials (ISO 4823:2000)
Zahnheilkunde - Elastomere Abformmassen (ISO 4823:2000)
Art dentaire - Produits pour empreintes, a base d'élastomeres (ISO 4823:2000)
La présente Norme internationale fixe les exigences et les essais d'évaluation des produits pour empreintes dentaires à base d'élastomères.
Dentistry - Elastomeric impression materials (ISO 4823:2000)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 4823:2001
01-november-2001
1DGRPHãþD
SIST EN 24823:2000
Dentistry - Elastomeric impression materials (ISO 4823:2000)
Dentistry - Elastomeric impression materials (ISO 4823:2000)
Zahnheilkunde - Elastomere Abformmassen (ISO 4823:2000)
Art dentaire - Produits pour empreintes, a base d'élastomeres (ISO 4823:2000)
Ta slovenski standard je istoveten z: EN ISO 4823:2000
ICS:
11.060.10 =RERWHKQLþQLPDWHULDOL Dental materials
SIST EN ISO 4823:2001 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 4823:2001
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SIST EN ISO 4823:2001
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SIST EN ISO 4823:2001
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SIST EN ISO 4823:2001
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SIST EN ISO 4823:2001
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SIST EN ISO 4823:2001
INTERNATIONAL ISO
STANDARD 4823
Third edition
2000-12-15
Dentistry — Elastomeric impression
materials
Art dentaire — Produits pour empreintes, à base d'élastomères
Reference number
ISO 4823:2000(E)
©
ISO 2000
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
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ii © ISO 2000 – All rights reserved
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
Contents Page
Foreword.iv
1 Scope .1
2 Normative references .1
3 Terms and definitions .1
4 Classification.2
5 Biocompatibility advisory.3
6 Requirements for characteristics and properties .3
6.1 Component colours.3
6.2 Mixing time (hand-spatulated or hand-kneaded mixes).3
6.3 Working time .3
6.4 Compatibility with gypsum .3
7 Sampling.4
8 Test methods — General .4
8.1 Laboratory conditions.4
8.2 Apparatus function verification.4
8.3 Material manipulation and specimen preparation.4
8.4 Pass/fail determinations .4
8.5 Expression of test results.5
9 Test methods — Specific .5
9.1 Mixing-time test.5
9.2 Consistency test .5
9.3 Working-time test.7
9.4 Detail reproduction test .8
9.5 Linear dimensional change test.9
9.6 Test for compatibility with gypsum .11
9.7 Elastic recovery test.12
9.8 Strain-in-compression test .14
10 Requirements for information in manufacturer's instructions .15
10.1 General.15
10.2 Identifying information.15
10.3 Specific instructions for use .15
11 Requirements for packaging and labelling .16
11.1 Packaging requirements .16
11.2 Labelling requirements .17
Annex A (informative) Working-time test instrument components — Possible sources.32
Bibliography.33
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SIST EN ISO 4823:2001
ISO 4823:2000(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 3.
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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 4823 was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee
SC 2, Prosthodontic materials.
This third edition cancels and replaces the second edition (ISO 4823:1992), which has been revised to reflect the
following technical differences:
— the60s limiton Mixing time (5.4, second edition) has been eliminated;
— the Consistency test requirement for Type 1 and Type 2 impression materials has been relaxed (see
Table 1, both editions);
— a more realistic approach for making pass/fail determinations (8.4);
— apparatus and procedures specified for the Working-time test (9.3) and the Elastic recovery tests (9.7)
provide for more objective test results than those specified in 7.4 and 7.6 of the second edition;
— Figure 2 illustrates how the instrument depicted in Figure 4 of the second edition can be modified to make it
suitable for use in the Consistency test as well as for the Strain-in-compression test;
— Figure 15 illustrates how the split mould shown in Figure 5 of the second edition can be modified to provide
for more uniformly shaped specimens.
Annex A of this International Standard is for information only.
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SIST EN ISO 4823:2001
INTERNATIONAL STANDARD ISO 4823:2000(E)
Dentistry — Elastomeric impression materials
1 Scope
This International Standard specifies requirements and tests for evaluating elastomeric dental impression
materials.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 1942, Dental vocabulary.
ISO 6873, Dental gypsum products.
3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 1942 and the following
apply.
3.1
consistency
degree of firmness with which particles of a material, prepared for use, cohere so as to allow the material to flow, or
resist flow, as required to achieve the purpose for which it is intended
3.2
elastic recovery test
compression set (deprecated)
permanent deformation (deprecated)
recovery from deformation (deprecated)
�elastic impression materials� method of determining whether the materials possess the elastic properties required
to recover adequately after deformation occurring when the materials, used for forming impressions, are removed
from the mouth
3.3
extrusion mixing
method by which two or more material components are extruded from their separate immediate containers through
a special mixing tip, from which the components emerge as a homogeneous mixture
3.4
hand mixing
method of mixing the components of a material by means of manual kneading or spatulation
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
3.5
immediate container
container which is in direct contact with a material or a component thereof
NOTE An immediate container may be an unlabelled container protected by a more durable labelled outer packaging
component such as a can, carton or drum. If it is strong enough to protect its contents without outer packaging, an immediate
container can also serve as a primary container on which labelling may be required.
3.6
mixing time
time, measured from first contact between different components of a material being mixed, required to achieve a
homogeneous mixture when the components are mixed according to the manufacturer’s instructions
NOTE The time of first contact between extrusion-mixed material components is defined as the time when the material
components can be seen entering into the mixing nozzle.
3.7
outer package
wrapping or carton, which may be required by law or a standard to bear specified labelling, used to cover one or
more immediate or primary containers in preparation for retail marketing
3.8
primary container
retail marketing packaging component, such as a bottle, carton, drum, jar, tube, etc., which may be required by law
or a standard to bear specified labelling
NOTE A primary container may also be an immediate container.
3.9
strain-in-compression test
�elastic impression materials� method of measuring the flexibility/stiffness property ranges of materials so as to
determine whether the set materials, when formed as impressions, 1) can be removed from the mouth without
injury to impressed oral tissues, and 2) will have adequate stiffness, in the more flexible portions of impressions, to
resist deformation when model-forming products are poured against them
3.10
working time
period of time, beginning with the commencement of mixing and ending before the material being mixed has begun
to exhibit elastic properties that will prevent the material from being manipulated as required to form an impression
or a mould having the desired surface detail and dimensional characteristics
4 Classification
Materials covered by this International Standard are classified according to consistencies determined immediately
after completion of mixing according to the manufacturer’s instructions (10.3):
� Type 0: putty consistency
� Type 1: heavy-bodied consistency
� Type 2: medium-bodied consistency
� Type 3: light-bodied consistency
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
5 Biocompatibility advisory
Specific qualitative and quantitative requirements for freedom from biological hazards are not included in this
International Standard. It is recommended that, in assessing possible biological or toxicological hazards, reference
be made to ISO 7405 and ISO 10993-1 (see Bibliography).
6 Requirements for characteristics and properties
6.1 Component colours
Different components intended for use in the same mixture shall be supplied in contrasting colours to provide a
means of determining when the components have been thoroughly mixed.
6.2 Mixing time (hand-spatulated or hand-kneaded mixes)
When the impression material components are combined according to the manufacturer’s instructions given in
10.3 e) and the results of the mixing are evaluated according to 9.1, the average time required to achieve a
homogeneous mixture (essentially streak free) shall not exceed the time stated by the manufacturer in 10.3 e).
6.3 Working time
When tested according to 9.3, the working time shall not be less than that stated in the manufacturer’s instructions
given in 10.3 f), and shall be at least 30 s longer than the time required to obtain a homogeneous mix (see 6.2 and
9.1).
6.4 Compatibility with gypsum
The impression material shall impart a smooth surface to, and separate cleanly from, the gypsum model material
poured against it (see Table 1).
Table 1 — Additional characteristic and physical property requirements
Test subclause No. and description
9.2 9.4 9.5 9.6 9.7 9.8
Consistency
Detail Linear Compatibility
Elastic Strain-in-
reproduction with gypsum
Type dimensional
(Test disc
recovery compression
change
diameter)
(Line width (Line width
% %
a a
reproduced) % reproduced)
mm
min. max. �m max. �m min. min. max.
0 — 35 75 1,5 75 96,5 0,8 20
1 — 35 50 1,5 50 96,5 0,8 20
2 31 41 20 1,5 50 96,5 2,0 20
336 — 20 1,5 50 96,5 2,0 20
a
The line reproduction shall be considered satisfactory if the required line a, b, or c is continuous between the lines d
1
and d . See test block in Figure 12.
2
NOTE Requirements for information to be included in the manufacturer's instructions for use, packaging and labelling are
listed in clauses 10 and 11.
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
7 Sampling
Samples of materials to be tested shall be procured from a single manufacturing batch as packaged for retail
marketing.
NOTE A volume of about 900 ml of the mixed material will usually be enough for conducting all the tests and for the
considerable practice which may be necessary for the test operator to become proficient in specimen preparation and testing.
CAUTION — Before opening any packaging component, examine the labelling for compliance with 11.2 and
for any precautions that should be observed in use and storage of the material. Before opening any
immediate container examine the instructions for compliance with clause 10.
8 Test methods — General
8.1 Laboratory conditions
Unless otherwise specified in this International Standard, conduct all specimen preparation and testing under
ambient laboratory conditions of (23 � 2) °Cand (50 � 10) % relative humidity, and bring all equipment and
materials used in the tests to the ambient temperature before use in specimen preparation and testing.
8.2 Apparatus function verification
Examine all accessories, instruments, and equipment before they are used to determine whether they are in
acceptable working order. Perform whatever calibration steps are necessary to ensure that the items comply with
specifications stated for them in this International Standard or in any normative document quoted therein.
8.3 Material manipulation and specimen preparation
Unless otherwise specified:
� use the equipment and procedures recommended in the manufacturer's instructions when preparing and
manipulating the materials used for forming the test specimens. For materials requiring hand mixing, use only
mass/mass proportioning of ingredients [10.3 c)];
� when the instructions specify manual kneading as a means of combining putty material components, cover the
hands with gloves or polymer sheeting [10.3 d)] which will not react with the material to alter its behaviour;
� mix a volume of at least 15 ml for each specimen (the approximate amount required for a medium-sized
complete arch impression);
� time the schedules for specimen preparation and testing using an instrument such as a stop-watch accurate to
1 s over a 30 s period.
8.4 Pass/fail determinations
The minimum number of specimens required for pass/fail determinations shall be either three or five, as indicated
beside the related specimen preparation or test procedure headings. Unless otherwise specified, the following rules
apply:
� for a three-specimen minimum, make a series of three specimens initially. If at least two of the three
specimens comply with the related requirement, the material passes. If none complies, the material fails. If only
one specimen complies, make three additional specimens. If all three of the additional specimens comply, the
material passes; otherwise the material fails;
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
� for a five-specimen minimum, make and test a series of five specimens initially. If at least four of the five
specimens comply with the related requirement, the material passes. If only one or two specimens comply, the
material fails. If only three specimens comply, make a series of five additional specimens. If all five of the
second series of specimens comply, the material passes; otherwise the material fails.
8.5 Expression of test results
Report the number of specimens tested, the number complying with the specified requirement and whether the
material passes or fails.
9 Test methods — Specific
9.1 Mixing-time test
9.1.1 Apparatus
9.1.1.1 Recommended mixing apparatus [10.3 d)]
9.1.1.2 Timing device (8.3)
9.1.2 Specimen preparation and test procedure (five specimens)
Proportion and mix the required volume of material (8.3) for each specimen. Record the time required to obtain a
homogeneous mixture for each specimen. Calculate the mean of the results for the five specimens.
NOTE Mixes made for this test may be used to provide increments of material needed for the consistency test (9.2)
9.1.3 Pass/fail determination and expression of results
Determine whether the mean result obtained in accordance with 9.1.2 complies with 6.2 and report the results.
9.2 Consistency test
9.2.1 Apparatus and materials
9.2.1.1 Two glass plates, one to serve as a base plate, and one to serve as a loading plate (Figure 2).
Dimensions for the loading plate shall be approximately 60 mm by 60 mm and at least 3 mm thick. Dimensions of
the base plate may be greater.
9.2.1.2 Material delivery system, such as the one illustrated in Figure 1, for delivering a volume of
(0,5 � 0,02) ml of the material onto the base plate.
9.2.1.3 Polyethylene sheets, wrinkle-free, approximately 60 mm by 60 mm and 0,035 mm thick (one per
specimen).
9.2.1.4 Polyethylene sheet discs, approximately 10 mm in diameter and 0,035 mm thick (two per specimen).
9.2.1.5 Elastomeric plug, for forming the floor of the test increment-containing cavity.
9.2.1.6 Test instrument for applying a force of (14,7 � 0,1) N (Figure 2).
The mass of the glass loading plate shall be included as part of the test load.
NOTE The dial indicator illustrated as a part of the test instrument in Figure 2 plays no part in the consistency test.
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
9.2.1.7 Linear measuring instrument, accurate to 0,5 mm, for measuring diameters of the test specimen disc
(9.2.3).
9.2.1.8 Timing device (8.3).
9.2.2 Advance preparation steps
Accomplish the following steps before beginning any of the test procedures:
� adjust the test instrument (9.2.1.6.) so that the contact surface of the loading shaft foot can descend within
5 mm of the top surface of the instrument base;
� cover the top surface of the base plate (9.2.1.1) with a polyethylene sheet (9.2.1.3). A thin film of silicon grease
applied to the bottom of the loading plate will secure the polyethylene sheet covering in place, as required for
the test;
� use the depth-gauge end of the plunger (Figure 1) to push the elastomeric plug (9.2.1.5) into the tapered end
of the dispensing tube to the depth allowed by the stop;
� use the depth-gauge end of the plunger to seat two of the polyethylene sheet discs (9.2.1.4) to cover the cavity
floor formed by the plug.
9.2.3 Specimen preparation and test procedure (3 specimens)
Accomplish the following steps within 25 s after the completion of mixing:
� slightly overfill the cavity in the dispensing tube (Figure 1) with the mixed material and strike off the excess to
form the test increment;
� push the increment-extruding end of the plunger against the elastomeric plug to expel the test increment,
along with one, or both, of the polyethylene discs, onto the centre of the base plate. Do not attempt to separate
the discs from the test increment;
� centre the increment on the base of the test instrument (9.2.1.6) directly under the elevated loading-shaft foot;
� place and hold the glass loading plate centred and in contact with the shaft foot;
� allow the 14,7 N load to descend slowly onto the increment.
To obtain a more uniformly circular specimen disc, keep the glass plates as parallel as possible during loading and
keep rotation of the plates to a minimum.
Allow the total load to rest on the specimen-forming assembly for 5 s. Lift the foot of the loading shaft from contact
with the loading plate and allow the assembly to remain at room temperature for at least 15 min. Then separate the
loading plate from the assembly so as to leave the specimen on the base plate. Use the measuring instrument
(9.2.1.7) to make two diametral measurements of the specimen, one across the major diameter of the disc and one
across the minor diameter. Report the average of the two measurements as the diameter to be considered when
determining whether the specimen complies with the diameter requirement specified in Table 1.
9.2.4 Pass/fail determination and expression of results
See 8.4 and 8.5.
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
9.3 Working-time test
9.3.1 Apparatus and materials
9.3.1.1 Working-time test instrument, including the parts illustrated in Figure 3 through to Figure 10, as well
as the three electronic components listed immediately below.
9.3.1.2 Linear variable displacement transducer (LVDT), having a linear working range > 12,5 mm. The
transducer shall be passive, i.e. not spring-loaded.
9.3.1.3 DC power supply,(+ 15V and � 15 V regulated), for modulating the LVDT signals.
9.3.1.4 Chart recorder, compatible with the LVDT and associated equipment.
9.3.1.5 Mixing apparatus [10.3 d)].
9.3.1.6 Timing device (8.3).
9.3.2 Pretest instrumentation function verification and assembly
9.3.2.1 Check for friction
Before using the test instrument (9.3.1.1), use the following procedure to determine whether the friction between
the bearing areas of glide track (Figure 5) and the sliding polymer blocks (Figure 7) is within acceptable limits (see
also Figure 3):
� do not use lubricants in attempts to reduce friction;
� detach the LVDT core carrier rod (Figure 3) from the polymer block 4 ;
L
� clean and dry the bearing surfaces of the sliding blocks and glide track and examine them for defects that can
be detected by touch (burrs, nicks, etc.). Eliminate any such defects;
� seat the sliding blocks in the glide track, and use the perforated test plate (Figure 8) and the plate aligning and
locking pins, Parts 5 and 5 (Figure 3 and Figure 9) to relate the parts as for testing;
L R
� elevate one end of the instrument so that the base is at an approximate 20° angle to horizontal;
� move by hand the sliding block/perforated test plate assembly in the glide track to the upper extreme position
and release it immediately.
If the assembly moves freely to the lower extreme position under the pull of gravity, the friction is within acceptable
limits.
Repeat the steps described above, with the opposite end of the instrument elevated, to determine whether freedom
of movement in the opposite direction is also acceptable.
If the friction cannot be reduced to acceptable limits by removal of burrs, contaminates, etc., it may be necessary to
resurface the bearing areas to eliminate binding interferences that may be contributing to the friction.
Upon achieving acceptable limits for friction, remove the test plate, reattach the core carrier rod to the sliding block
4 in Figure 3 and proceed with assembly of the instrumentation.
L
9.3.2.2 Instrumentation assembly
Connect the LVDT (9.3.1.2) to the recorder (9.3.1.4) through the power supply (9.3.1.3). Then adjust the LVDT
body position as required to establish a body/core relationship whereby a full-scale deflection of the recorder pen
indicates a rheometer displacement of 3,5 mm. Confirm that the recorder pen reflects a linear function of the
rheometer displacement.
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SIST EN ISO 4823:2001
ISO 4823:2000(E)
9.3.3 Test procedure (five specimens)
When combining hand-mixed materials, start the timing device (9.3.1.6) at the commencement of mixing. For the
extrusion mixed materials, delay starting the timing device until the material components can be seen entering into
the mixing nozzle. After completion of mixing, accomplish the following steps within 55 s:
� deposit an increment of about 2 ml of the material centred on the slotted surface of the test specimen pedestal
(Figure 3 and Figure 6);
� force the perforated test plate into the centre of the impression material increment until the undersides of both
ends of the plate contact the upper surfaces of the sliding polymer blocks, 4 and 4 , and so that the mixed
L R
material extrudes through at least 28 of the perforations;
� align the locking
...
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