EN ISO 4823:2021

Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)

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.

Zahnheilkunde - Elastomere Abform- und Bissregistriermaterialien (ISO 4823:2021)

Dieses Dokument legt die Anforderungen und ihre Prüfverfahren für elastomere Abform- und Bissregistriermaterialien fest.
ANMERKUNG   Dieses Dokument geht nicht auf mögliche biologische Gefahren ein, die mit den Materialien in Zusammenhang stehen. Die Beurteilung dieser biologischen Gefahren wird in ISO 7405 und der Normenreihe ISO 10993 behandelt.

Médecine bucco-dentaire - Produits pour empreintes et matériaux pour enregistrement des rapports intermaxillaires à base d’élastomères (ISO 4823:2021)

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.
NOTE       Le présent document ne traite pas des dangers biologiques éventuellement associés aux matériaux. L'évaluation de ces dangers est traitée dans l'ISO 7405 et dans la série de normes ISO 10993.

Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO 4823:2021)

General Information

• Status: Published
• Publication Date: 23-Mar-2021
• Withdrawal Date: 29-Sep-2021
• ICS: 11.060.10 - Dental materials
• Technical Committee: CEN/TC 55 - Dentistry
• Drafting Committee: CEN/TC 55 - Dentistry
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 24-Mar-2021
• Completion Date: 24-Mar-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Ref Project: SIST EN ISO 4823:2021 - Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)

Relations

• Replaces: EN ISO 4823:2015 - Dentistry - Elastomeric impression materials (ISO 4823:2015)
• Effective Date: 28-Jun-2017
• Revised: prEN ISO 4823 - Dentistry - Elastomeric impression and bite registration materials (ISO/DIS 4823:2024)
• Effective Date: 04-Oct-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2021
Nadomešča:
SIST EN ISO 4823:2015
Zobozdravstvo - Elastomerni materiali za odtise in ugriz (ISO 4823:2021)
Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2021)
Zahnheilkunde - Elastomere Abformmaterialien und Bissregistriermassen (ISO
4823:2021)
Médecine bucco-dentaire - Produits pour empreintes et matériaux pour enregistrement
des rapports intermaxillaires à base d’élastomères (ISO 4823:2021)
Ta slovenski standard je istoveten z: EN ISO 4823:2021
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
March 2021
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 4823:2015
English Version
Dentistry - Elastomeric impression and bite registration
materials (ISO 4823:2021)
Médecine bucco-dentaire - Produits pour empreintes et Zahnheilkunde - Elastomere Abformmaterialien und
matériaux pour enregistrement des rapports Bissregistriermassen (ISO 4823:2021)
intermaxillaires à base d'élastomères (ISO 4823:2021)
This European Standard was approved by CEN on 17 March 2021.

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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 4823:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 4823:2021) 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 September 2021, and conflicting national standards
shall be withdrawn at the latest by September 2021.
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 4823:2015.
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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 4823:2021 has been approved by CEN as EN ISO 4823:2021 without any modification.

INTERNATIONAL ISO
STANDARD 4823
Fifth edition
2021-02
Dentistry — Elastomeric impression
and bite registration materials
Médecine bucco-dentaire — Produits pour empreintes et matériaux
pour enregistrement des rapports intermaxillaires à base
d’élastomères
Reference number
ISO 4823:2021(E)
©
ISO 2021
ISO 4823:2021(E)
© ISO 2021
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
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

ISO 4823:2021(E)
Contents Page
Foreword .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 3
5.1 Packaging requirements . 3
5.2 Labelling requirements . 3
5.2.1 Outer packages (containing one or more primary containers) . . 3
5.2.2 Primary containers within outer packaging . 3
5.3 Requirements for information in the manufacturer's instructions . 4
5.3.1 General. 4
5.3.2 Identifying information . . 4
5.3.3 Specific instructions for use . 4
5.4 Requirements for characteristics and properties . 5
5.4.1 Component colours (hand-spatulated or hand-kneaded mixes) . 5
5.4.2 Mixing time (hand-spatulated or hand-kneaded mixes). 5
5.4.3 Consistency . 5
5.4.4 Working time. 5
5.4.5 Detail reproduction . 5
5.4.6 Linear dimensional change . 5
5.4.7 Compatibility with gypsum . 5
5.4.8 Elastic recovery . 5
5.4.9 Strain in compression . 5
5.4.10 Minimum time in the oral cavity for bite registration materials . 6
5.4.11 Compression set of bite registration materials . 6
5.4.12 Hardness of bite registration materials . 6
6 Pre-test planning approaches . 6
6.1 Sampling . 6
6.2 Pre-test product examinations . 7
6.2.1 Examinations for compliance with labelling requirements . 7
6.2.2 Examinations for effectiveness of the packaging . 7
6.2.3 Examinations for compliance with requirements for instructions for use . 7
6.3 Essential pre-test preparatory practices . 7
6.3.1 Laboratory conditions . 7
6.3.2 Apparatus function verification steps . 8
6.3.3 Volume of materials to be mixed for each specimen . 8
6.3.4 Standardized approaches to proportioning, mixing, and handling of hand
mixed materials to be tested. 8
6.3.5 Timing for the specimen preparation and test procedures . 8
6.3.6 Simulated oral time/temperature treatment of specimens formed in
completely closed mould assemblies . 8
6.4 Pass/fail determinations . 8
6.5 Expression of test results . 8
7 Test methods — Specific . 8
7.1 Mixing time. 8
7.1.1 Apparatus . 8
7.1.2 Specimen preparation and test procedure (five specimens) . 9
7.1.3 Pass/fail determination and expression of results. 9
7.2 Consistency . 9
7.2.1 Apparatus and materials . 9
7.2.2 Advance preparation steps. 9
ISO 4823:2021(E)
7.2.3 Specimen preparation and test procedure (5 specimens) .10
7.2.4 Pass/fail determination and expression of results.
...