SIST EN ISO 23401-1:2023
(Main)Dentistry - Chairside denture base relining materials - Part 1: Hard type materials (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
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 23401-1:2023
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
SIST EN ISO 23401-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 23401-1:2023
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SIST EN ISO 23401-1:2023
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.
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SIST EN ISO 23401-1:2023
EN ISO 23401-1:2023 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 23401-1:2023
EN ISO 23401-1:2023 (E)
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.
3
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SIST EN ISO 23401-1:2023
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SIST EN ISO 23401-1:2023
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 2023
---------------------- Page: 7 ----------------------
SIST EN ISO 23401-1:2023
ISO 23401-1:2023(E)
COPYRIGHT PROTECTED DOCUMENT
© 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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2023 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 23401-1:2023
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 .10
7.1 Packaging . 10
7.2 Marking and manufacturer’s instructions for use . 10
Bibliography .12
iii
© ISO 2023 – All rights reserved
---------------------- Page: 9 ----------------------
SIST EN ISO 23401-1:2023
ISO 23401-1:2023(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.
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/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).
A list of all parts in the ISO 23401 series can be found on the ISO website.
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.
iv
© ISO 2023 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 23401-1:2023
ISO 23401-1:2023(E)
Introduction
The purpose of denture base relining materials is to improve the fit of dentures to the oral mucosa.
The materials can reline the denture the same day. Thus, they can be a useful material for the general
denture patients and especially for bedridden patients who may have no access to dental surgery.
Requirements and test methods for the soft type materials are defined in detail by ISO 10139-1 and
ISO 10139-2, but it is extremely difficult to incorporate the hard type materials in these International
Standards of soft lining materials because of the differences in the main components, curing
mechanisms and physical properties.
Also, chairside denture base relining materials and denture base materials covered by ISO 20795-1 and
ISO 20795-2 differ in terms of polymerization method and required properties. As chairside denture
base relining materials are partially or even mainly handled intraorally, properties such as consistency
and exothermicity during intra-oral polymerization are quite important.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included
in this document, but it is recommended that, in assessing possible biological or toxicological hazards,
reference be made to ISO 10993-1 and ISO 7405.
v
© ISO 2023 – All rights reserved
---------------------- Page: 11 ----------------------
SIST EN ISO 23401-1:2023
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SIST EN ISO 23401-1:2023
INTERNATIONAL STANDARD ISO 23401-1:2023(E)
Dentistry — Chairside denture base relining materials —
Part 1:
Hard type materials
1 Scope
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).
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 1942, Dentistry — Vocabulary
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 4545-1, Metallic materials — Knoop hardness test — Part 1: Test method
ISO 6344-3, Coated abrasives — Determination and designation of grain size distribution — Part 3:
Microgrit sizes P240 to P5000
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 20795-1, Dentistry — Base polymers — Part 1: Denture base polymers
3 Terms and definitions
For the purposes of this document, the
...
SLOVENSKI STANDARD
oSIST prEN ISO 23401-1:2022
01-junij-2022
Zobozdravstvo - Osnovni obložni materiali za proteze - 1. del: Trde vrste
materialov (ISO/DIS 23401-1:2022)
Dentistry - Chairside denture base relining materials - Part 1: Hard type materials
(ISO/DIS 23401-1:2022)
Zahnheilkunde – Unterfütterungswerkstoffe am Behandlungsstuhl – Teil 1: Harte
Werkstoffe (ISO/DIS 23401-1:2022)
Médecine bucco-dentaire - Matériaux de rebasage pour base de prothèses dentaires -
Partie 1: Matériaux durs (ISO/DIS 23401-1:2022)
Ta slovenski standard je istoveten z: prEN ISO 23401-1
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 23401-1:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
oSIST prEN ISO 23401-1:2022
---------------------- Page: 2 ----------------------
oSIST prEN ISO 23401-1:2022
DRAFT INTERNATIONAL STANDARD
ISO/DIS 23401-1
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2022-04-21 2022-07-14
Dentistry — Chairside denture base relining materials —
Part 1:
Hard type materials
ICS: 11.060.10
This document is circulated as received from the committee secretariat.
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
ISO/CEN PARALLEL PROCESSING
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 23401-1:2022(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2022
---------------------- Page: 3 ----------------------
oSIST prEN ISO 23401-1:2022
ISO/DIS 23401-1:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
© ISO 2022 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 23401-1:2022
ISO/DIS 23401-1:2022(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 .10
7.1 Packaging . 10
7.2 Marking and manufacturer’s instructions for use . 10
Bibliography .12
iii
© ISO 2022 – All rights reserved
---------------------- Page: 5 ----------------------
oSIST prEN ISO 23401-1:2022
ISO/DIS 23401-1:2022(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.
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/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials.
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.
iv
© ISO 2022 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 23401-1:2022
ISO/DIS 23401-1:2022(E)
Introduction
The purpose of denture base relining materials is to improve the fit of dentures to the oral mucosa.
The materials can reline the denture the same day. Thus, they can be a useful material for the general
denture patients and especially for bedridden patients who may have no access to dental surgery.
Requirements and test methods for the soft type materials are defined in detail by ISO 10139-1 and
ISO 10139-2, but it is extremely difficult to incorporate the hard type materials in these International
Standards of soft lining materials because of the differences in the main components, curing
mechanisms, and physical properties.
Also, chairside denture base relining materials and denture base materials covered by ISO 20795-1 and
ISO 20795-2 differ in terms of polymerization method and required properties. As chairside denture
base relining materials are partially or even mainly handled intraorally, properties such as consistency
and exothermicity during intra-oral polymerization are quite important.
Specific qualitative and quantitative requirements for freedom from biological hazard are not included
in this document, but it is recommended that, in assessing possible biological or toxicological hazards,
reference be made to ISO 10993-1 and ISO 7405.
v
© ISO 2022 – All rights reserved
---------------------- Page: 7 ----------------------
oSIST prEN ISO 23401-1:2022
---------------------- Page: 8 ----------------------
oSIST prEN ISO 23401-1:2022
DRAFT INTERNATIONAL STANDARD ISO/DIS 23401-1:2022(E)
Dentistry — Chairside denture base relining materials —
Part 1:
Hard type materials
1 Scope
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. It 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).
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 1942, Dentistry — Vocabulary
ISO 3696:1987, Water for analytical laboratory use — Specification and test methods
ISO 4545-1, Metallic materials — Knoop hardness test — Part 1: Test method
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 20795-1, Dentistry — Base polymers — Part 1: Denture base polymers
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1942, ISO 20795-1 and
following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
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oSIST prEN ISO 23401-1:2022
ISO/DIS 23401-1:2022(E)
3.1
chairside denture base relining
denture base relining where the relining material is moulded and partially or completely polymerized
intraorally
3.2
peak temperature
maximum temperature during polymerization
4 Classification
4.1 Types
The chairside denture base relining materials are classified into the following types in accordance with
their methods of polymerization.
— Type 1: materials whose setting is effected by mixing initiator(s) and activator(s) (“self-curing”
materials);
— Type 2: materials whose setting is effected by the application of light from an external source (“light-
curing” materials);
— Type 3: materials whose setting is effected by mixing initiator(s) and activator(s) and also by the
application of light from an external source (“dual-curing” materials).
4.2 Classes
The chairside denture base relining materials are classified into the following classes in accordance
with material form.
— Class 1: powder and liquid
— Class 2: paste
— Class 3: sheet
5 Requirements
5.1 Appearance
5.1.1 Liquid
The liquid shall be homogeneous when tested in accordance with 6.4.1. The liquid shall be free of
deposits or sediment.
5.1.2 Powder, paste and sheet
The powder, paste, and sheet shall not contain extraneous materials when tested in accordance with
6.4.1. Separation of liquid (e.g. monomer) shall not be observed in the paste or sheet when tested in
a
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