SIST EN ISO 4823:2025
(Main)Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2025)
Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2025)
This document specifies the requirements and their test methods for elastomeric impression and bite registration materials.
Zahnheilkunde - Elastomere Abform- und Bissregistriermaterialien (ISO 4823:2025)
Dieses Dokument spezifiziert die Anforderungen und ihre Prüfverfahren für elastomere Abformmaterialien und Bissregistriermaterialien.
Médecine bucco-dentaire - Produits pour empreintes et matériaux pour enregistrement des rapports intermaxillaires à base délastomères (ISO 4823:2025)
Le présent document spécifie les exigences relatives aux produits pour empreintes et aux matériaux pour enregistrement des rapports intermaxillaires à base d’élastomères ainsi que les méthodes d’essai correspondantes
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO 4823:2025)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2025
Nadomešča:
SIST EN ISO 4823:2021
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO 4823:2025)
Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2025)
Zahnheilkunde - Elastomere Abform- und Bissregistriermaterialien (ISO 4823:2025)
Médecine bucco-dentaire - Produits pour empreintes et matériaux pour enregistrement
des rapports intermaxillaires à base délastomères (ISO 4823:2025)
Ta slovenski standard je istoveten z: EN ISO 4823:2025
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 4823
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2025
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 4823:2021
English Version
Dentistry - Elastomeric impression and bite registration
materials (ISO 4823:2025)
Médecine bucco-dentaire - Produits pour empreintes et Zahnheilkunde - Elastomere Abform- und
matériaux pour enregistrement des rapports Bissregistriermaterialien (ISO 4823:2025)
intermaxillaires à base d'élastomères (ISO 4823:2025)
This European Standard was approved by CEN on 21 June 2025.
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 CEN-CENELEC 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 CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4823:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 4823:2025) 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 December 2025, and conflicting national standards
shall be withdrawn at the latest by December 2025.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 4823:2021.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 4823:2025 has been approved by CEN as EN ISO 4823:2025 without any modification.
International
Standard
ISO 4823
Sixth edition
Dentistry — Elastomeric impression
2025-06
and bite registration materials
Médecine bucco-dentaire — Produits pour empreintes et
matériaux pour enregistrement des rapports intermaxillaires à
base d’élastomères
Reference number
ISO 4823:2025(en) © ISO 2025
ISO 4823:2025(en)
© ISO 2025
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
ISO 4823:2025(en)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 Component colours (not applicable for transparent materials) .2
5.2 Mixing time (hand-spatulated or hand-kneaded mixes) .3
5.3 Consistency .3
5.4 Working time .3
5.5 Detail reproduction .3
5.6 Linear dimensional change .3
5.7 Compatibility with gypsum .3
5.8 Elastic recovery .3
5.9 Strain in compression .3
5.10 Minimum time in the oral cavity for bite registration materials .3
5.11 Compression set of bite registration materials .3
5.12 Hardness of bite registration materials .3
6 Pre-test planning approaches . . 4
6.1 General .4
6.2 Sampling .4
6.3 Pre-test product examinations .4
6.3.1 General .4
6.3.2 Examinations for conformity with labelling requirements .4
6.3.3 Examinations for effectiveness of the packaging . .5
6.3.4 Examinations for compliance with requirements for instructions for use .5
6.4 Essential pre-test preparatory practices .5
6.4.1 Laboratory conditions .5
6.4.2 Apparatus function verification steps .5
6.4.3 Volume of materials to be mixed for each specimen .5
6.4.4 Proportioning, mixing and handling of hand-mixed materials to be tested .6
6.4.5 Timing for the specimen preparation and test procedures .6
6.4.6 Simulated oral time/temperature treatment of specimens formed in completely
closed mould assemblies .6
6.5 Pass/fail determinations .6
6.6 Expression of test results.6
7 Test methods . 6
7.1 Mixing time .6
7.1.1 Apparatus .6
7.1.2 Specimen preparation and test procedure (five specimens) .6
7.1.3 Pass/fail determination and expression of results .6
7.2 Consistency .7
7.2.1 Apparatus and materials .7
7.2.2 Advance preparation steps .7
7.2.3 Specimen preparation and test procedure (five specimens) .7
7.2.4 Pass/fail determination and expression of results .8
7.3 Working time .8
7.3.1 Apparatus .
...
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