EN ISO 4823:2000
(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, à base d'élastomères (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
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Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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
ISO 4823:2000(E)
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ii © ISO 2000 – All rights reserved
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
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.
iv © ISO 2000 – All rights reserved
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
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 e
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