EN ISO 23401-1:2023

Dentistry - Chairside denture base relining materials - Part 1: Hard type materials (ISO 23401-1:2023)

This document specifies the requirements for acrylic hard type materials used as chairside denture base relining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer.
Dentures which are relined by chairside denture base relining materials specified by this document are limited to those of acrylic.
This document is not applicable to either denture base relining materials that are for laboratory use or soft lining materials.
NOTE 1    Acrylic hard type materials contain acrylic and methacrylic monomers such as acrylic acid esters and substituted (meth)acrylic acid esters and their polymers.
NOTE 2    Acrylic dentures are made of polymers such as poly (acrylic acid esters), poly (substituted acrylic acid esters) and rubber-modified poly (methacrylic acid esters).

Zahnheilkunde - Unterfütterungswerkstoffe am Behandlungsstuhl - Teil 1: Harte Werkstoffe (ISO 23401-1:2023)

Dieses Dokument legt die Anforderungen an harte Acrylat-Werkstoffe zur Verwendung als Unterfütterungswerkstoffe am Behandlungsstuhl sowie die Prüfverfahren zum Feststellen der Einhaltung dieser Anforderungen fest. Dieses Dokument legt darüber hinaus Anforderungen an Verpackung und Kennzeichnung der Produkte sowie an die Gebrauchsanweisung fest, die vom Hersteller mitgeliefert wird.
Prothesen, die am Behandlungsstuhl mit in diesem Dokument festgelegten Unterfütterungswerkstoffen unterfüttert werden, sind auf solche aus Acrylat beschränkt.
Dieses Dokument ist nicht anwendbar auf Unterfütterungswerkstoffe für Laboranwendungen oder weichbleibende Unterfütterungswerkstoffe.
ANMERKUNG 1   Harte Acrylat-Werkstoffe enthalten Acrylat- und Methacrylatmonomere wie Acrylsäureester und substituierte (Meth)Acrylsäureester und deren Polymere.
ANMERKUNG 2   Acrylat-Prothesen bestehen aus Polymeren wie Poly(Akrylsäureester), substituierte Poly(Acrylsäureester) und kautschukmodifizierte Poly(Methacrylsäureester).

Médecine bucco-dentaire - Matériaux de rebasage pour base de prothèses dentaires - Partie 1: Matériaux durs (ISO 23401-1:2023)

Le présent document spécifie les exigences relatives aux matériaux durs en acrylique utilisés comme matériaux de rebasage au fauteuil pour prothèses dentaires et les méthodes d’essai permettant de déterminer la conformité à ces exigences. Ce document spécifie également les exigences relatives à l’emballage et au marquage des produits ainsi que les instructions d’utilisation devant être fournies par le fabricant.
Les prothèses dentaires qui sont rebasées par les matériaux de rebasage au fauteuil pour base de prothèses dentaires spécifiés dans le présent document sont limitées aux prothèses en acrylique.
Le présent document n’est applicable ni aux matériaux de rebasage pour base de prothèses dentaires destinés à un usage en laboratoire ni aux matériaux de rebasage souples.
NOTE 1        Les matériaux durs en acrylique contiennent des monomères acryliques et méthacryliques tels que des esters d’acide acrylique et des esters d’acide (méth)acrylique substitués et leurs polymères.
NOTE 2        Les prothèses dentaires en acrylique sont constituées de polymères tels que les poly(esters d’acide acrylique), les poly(esters d’acide acrylique substitués) et les poly(esters d’acide méthacrylique) modifiés avec du caoutchouc.

Zobozdravstvo - Osnovni obložni materiali za proteze - 1. del: Trde vrste materialov (ISO 23401-1:2023)

Ta dokument določa zahteve za trdne akrilne materiale, ki se uporabljajo kot materiali za
oblaganje osnove sedalne proteze, in preskusne metode za določanje skladnosti s temi zahtevami. Ta
dokument prav tako določa zahteve za embalažo in označevanje izdelkov in za navodila
za uporabo, ki jih mora podati proizvajalec.
Proteze, obnovljene z materiali za oblaganje osnove sedalne proteze, določene v tem dokumentu, so
omejene na akrilne izvedbe.
Ta dokument se ne uporablja za materiale za oblaganje osnove proteze, ki so namenjeni laboratorijski uporabi, in za
mehke materiale za oblaganje.
OPOMBA 1: Trdni akrilni materiali vsebujejo akrilne in metakrilat monomere, kot so estri akrilne kisline in nadomestni estri metakrilat/akrilne kisline in njihovi polimeri.
OPOMBA 2: Akrilne proteze so izdelane iz polimerov, kot so estri (poli)akrilne kisline, estri nadomestne (poli)akrilne kisline in estri z gumo modificirane metakrilat/akrilne kisline.

General Information

• Status: Published
• Publication Date: 28-Mar-2023
• 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: 29-Mar-2023
• Due Date: 07-Apr-2024
• Completion Date: 29-Mar-2023
• Ref Project: SIST EN ISO 23401-1:2023 - Dentistry - Chairside denture base relining materials - Part 1: Hard type materials (ISO 23401-1:2023)

Standards Content (Sample)

SLOVENSKI STANDARD
01-maj-2023
Zobozdravstvo - Osnovni obložni materiali za proteze - 1. del: Trde vrste
materialov (ISO 23401-1:2023)
Dentistry - Chairside denture base relining materials - Part 1: Hard type materials (ISO
23401-1:2023)
Zahnheilkunde - Unterfütterungswerkstoffe am Behandlungsstuhl - Teil 1: Harte
Werkstoffe (ISO 23401-1:2023)
Médecine bucco-dentaire - Matériaux de rebasage pour base de prothèses dentaires -
Partie 1: Matériaux durs (ISO 23401-1:2023)
Ta slovenski standard je istoveten z: EN ISO 23401-1:2023
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 23401-1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2023
EUROPÄISCHE NORM
ICS 11.060.10
English Version
Dentistry - Chairside denture base relining materials - Part
1: Hard type materials (ISO 23401-1:2023)
Médecine bucco-dentaire - Matériaux de rebasage pour Zahnheilkunde - Unterfütterungswerkstoffe am
base de prothèses dentaires - Partie 1: Matériaux durs Behandlungsstuhl - Teil 1: Harte Werkstoffe (ISO
(ISO 23401-1:2023) 23401-1:2023)
This European Standard was approved by CEN on 9 March 2023.

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
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 23401-1:2023 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 23401-1:2023) 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 2023, and conflicting national standards
shall be withdrawn at the latest by September 2023.
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.
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 23401-1:2023 has been approved by CEN as EN ISO 23401-1:2023 without any
modification.
INTERNATIONAL ISO
STANDARD 23401-1
First edition
2023-03
Dentistry — Chairside denture base
relining materials —
Part 1:
Hard type materials
Médecine bucco-dentaire — Matériaux de rebasage pour base de
prothèses dentaires —
Partie 1: Matériaux durs
Reference number
ISO 23401-1:2023(E)
ISO 23401-1:2023(E)
© ISO 2023
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 23401-1:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
4.1 Types . 2
4.2 Classes . 2
5 Requirements . 2
5.1 Appearance . 2
5.1.1 Liquid . 2
5.1.2 Powder, paste and sheet . 2
5.2 Consistency . 2
5.3 Peak temperature . 3
5.4 Porosity and defects . 3
5.5 Surface finish . 3
5.6 Water sorption . 3
5.7 Water solubility . . 3
5.8 Knoop hardness . 3
6 Test methods . 3
6.1 Sampling . 3
6.2 Preparation of test specimens . 3
6.3 Conditions for testing . 3
6.4 Visual inspection . 4
6.4.1 Appearance . 4
6.4.2 Porosity and defects . 4
6.4.3 Surface finish . 4
6.5 Consistency . 4
6.5.1 Apparatus . 4
6.5.2 Procedure . 5
6.6 Peak temperature . 5
6.6.1 Apparatus . 5
6.6.2 Procedure . 5
6.7 Water sorption and solubility . 6
6.7.1 Materials . 6
6.7.2 Apparatus . 6
6.7.3 Preparation of test specimens . 8
6.7.4 Procedure . 8
6.7.5 Calculation and expression of results. 9
6.8 Knoop hardness . 9
6.8.1 Apparatus . 9
6.8.2 Preparation of test specimens . 10
6.8.3 Procedure . 10
7 Requirement for packaging, marking and instructions supplied by
the manufacturer .
...