prEN ISO 4823

SLOVENSKI STANDARD
01-september-2024
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO/DIS 4823:2024)
Dentistry - Elastomeric impression and bite registration materials (ISO/DIS 4823:2024)
Zahnheilkunde - Elastomere Abform- und Bissregistriermaterialien (ISO/DIS 4823:2024)
Médecine bucco-dentaire - Produits pour empreintes et matériaux pour enregistrement
des rapports intermaxillaires à base délastomères (ISO/DIS 4823:2024)
Ta slovenski standard je istoveten z: prEN ISO 4823
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 4823
ISO/TC 106/SC 2
Dentistry — Elastomeric impression
Secretariat: ANSI
and bite registration materials
Voting begins on:
Médecine bucco-dentaire — Produits pour empreintes et
2024-06-19
matériaux pour enregistrement des rapports intermaxillaires à
Voting terminates on:
base d’élastomères
2024-09-11
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
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Reference number
ISO/DIS 4823:2024(en)
DRAFT
ISO/DIS 4823:2024(en)
International
Standard
ISO/DIS 4823
ISO/TC 106/SC 2
Dentistry — Elastomeric impression
Secretariat: ANSI
and bite registration materials
Voting begins on:
Médecine bucco-dentaire — Produits pour empreintes et
matériaux pour enregistrement des rapports intermaxillaires à
Voting terminates on:
base d’élastomères
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
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Published in Switzerland Reference number
ISO/DIS 4823:2024(en)
ii
ISO/DIS 4823:2024(en)
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.
The procedures used to develop this document and those intended for its further maintenance are described in the
ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types of ISO
documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC
Directives, Part 2 (see www.iso.org/directives).
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. Details of any patent rights identified
during the development of the document will be in the Introduction and/or on the ISO list of patent declarations
received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not constitute an
endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related
to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO)
principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials, in collaboration with the European Committee for Standardization (CEN) Technical
Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN
(Vienna Agreement).
This sixth edition cancels and replaces the fifth edition (ISO 4823:2021), which has been technically revised along
with editorial updates. The changes applied include:
— packaging and instructions for use requirements have been updated;
— editorial corrections have been made.
Any feedback or questions on this document should be directed to the user’s national standards body. A complete
listing of these bodies can be found at www.iso.org/members.html.
v
ISO/DIS 4823:2024(en)
Dentistry — Elastomeric impression and bite registration materials
1 Scope
This document specifies the requirements and their test methods for elastomeric impression and bite registration
materials.
NOTE This document does not address possible biological hazards associated with the materials. Assessment of these
hazards is addressed in ISO 7405 and the ISO 10993 series.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements 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 48-4:2018, Rubber, vulcanized or thermoplastic — Determination of hardness — Part 4: Indentation hardness by
durometer method (Shore hardness)
ISO 1942, Dentistry — Vocabulary
ISO 6873:2013, Dentistry — Gypsum products
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at http://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
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
3.2
elastic recovery
elastic properties required to recover adequately after deformation
3.3
extrusion mixing
method by which two or more material components are extruded simultaneously from their separate primary
containers through a mixing nozzle from which the material 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
3.5
hardness
resistance to indentation
ISO/DIS 4823:2024(en)
Note 1 to entry: In this document, it is Shore hardness according to ISO 48-4:2018, Type A.
[SOURCE: ISO 1382:2020, 3.247, modified – Note 1 to entry added.]
3.6
minimum time in the oral cavity
minimum time span the material stays in the oral cavity to sufficiently minimize deformation
3.7
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 1 to entry: 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.
3.8
outer package
wrapping or carton, used to cover one or more primary containers in preparation for retail marketing
Note 1 to entry: Legislation or specific standards can apply.
3.9
primary packaging
container designed to come into direct contact with the product
[SOURCE: ISO 21067-1:2016, 2.2.3, modified — “packaging” replaced with “container” in the definition.]
3.10
strain in compression
flexibility/stiffness property ranges of the materials that determines whether the set materials, when formed as
impressions, can be removed from the mouth without injury to the impressed oral tissues and have adequate
stiffness in the more flexible portions of impressions to resist deformation when model-forming products are
poured against them
3.11
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 prevents 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 document are classified according to the following consistencies determined immediately
after completion of mixing according to the manufacturer’s instructions (see 5.3):
— Type 0: putty consistency;
— Type 1: heavy-bodied consistency;
— Type 2: medium-bodied consistency;
— Type 3: light-bodied consistency;
— Type B: bite registration materials.
ISO/DIS 4823:2024(en)
5 Requirements
5.1.1 Component colours not applicable for transparent materials
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.
5.1.2 Mixing time (hand-spatulated or hand-kneaded mixes)
When the material components are combined according to the manufacturer’s instructions and the results of the
mixing are evaluated according to 7.1, the average time required to achieve a homogeneous mixture (essentially
streak-free) shall not exceed the time stated by the manufacturer.
5.1.3 Consistency
When tested according to 7.2, the test disc diameter shall be in the range given in Table 1 for the consistency
assigned to the material by the manufacturer.
5.1.4 Working time
When tested according to 7.3, the working time shall not be less than that stated in the manufacturer’s instructions.
5.1.5 Detail reproduction
When tested according to 7.4, the line width reproduced shall not exceed the appropriate value given in Table 1.
5.1.6 Linear dimensional change
When tested according to 7.5, the linear dimensional change shall not exceed the appropriate value given in Table 1.
5.1.7 Compatibility with gypsum
The impression material shall impart a smooth surface to and separate cleanly from the gypsum model material
poured against it. When tested according to 7.6, the line width reproduced shall not exceed the appropriate value
given in Table 1.
5.1.8 Elastic recovery
When tested according to 7.7, the elastic recovery shall be greater than or equal to the value given in Table 1.
5.1.9 Strain in compression
When tested according to 7.8, the strain in compression shall be in the appropriate range given in Table 1.
5.1.10 Minimum time in the oral cavity for bite registration materials
When tested according to 7.9, the minimum time in the oral cavity shall be smaller than or equal to the value given
by the manufacturer in the instructions for use.
5.1.11 Compression set of bite registration materials
When tested according to 7.9, the compression set after load removal shall be less or equal to the value given in
Table 1.
5.1.12 Hardness of bite registration materials
When tested according to 7.10, the hardness of the material shall be greater than or equal to the value given in
Table 1.
Table 1 — Characteristic and physical property requirements
Type Test subclause no. and description
ISO/DIS 4823:2024(en)
7.2 7.4 7.5 7.6 7.7 7.8 7.9 7.10
Consistency Detail Linear Compatibili Elastic Strain in Compressi Hardnes
reproducti dimensio ty with recover compression on set s
(test disc
on nal gypsum y
diameter) % mm Shore A
change
(line width (line width %
mm
reproduced % reproduced)
a a
)
max.
µm µm
min. max. min. min. | max. max. min.
0 — 35 75 1,5 75 96,5 0,8 | 20,0 - -
1 — 35 50 1,5 50 96,5 0,8 | 20,0 - -
2 31 41 20 1,5 50 96,5 2,0 | 20,0 - -
3 36 — 20 1,5 50 96,5 2,0 | 20.0 - -
B - - - 1,5 - - - | - 0,1 50
a
The line reproduction shall be considered satisfactory if the required line a, b, or c is continuous between the lines d and d . See test
1 2
block in Figure A.4.
6 Pre-test planning approaches
The information in this Clause is provided to help test operators avoid losses of time due to trial and error efforts
occurring when such information is not considered before test procedures, such as those described in Clause 7, are
begun.
6.1 Sampling
Observe the following guidelines when procuring sam
...