SIST EN ISO 10477:2020
(Main)Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020)
Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020)
This document classifies polymer-based crown and veneering materials used in dentistry and specifies
their requirements. It also specifies the test methods to be used to determine conformity to these
requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated
permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials
for which the manufacturer claims adhesion to the substructure without macro-mechanical retention
such as beads or wires.
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO 10477:2020)
Dieses Dokument beschreibt die Einteilung von polymerbasierten Kronen und Verblendwerkstoffen, die in der Zahnheilkunde verwendet werden, und legt ihre Anforderungen fest. Ebenso beschreibt es die Prüfverfahren, die zur Beurteilung der Konformität mit diesen Anforderungen verwendet werden.
Dieses Dokument gilt für polymerbasierte Kronen und Verblendwerkstoffe für im Labor hergestellte dauerhafte Verblendschalen oder Kronen. Es gilt ebenfalls für polymerbasierte dentale Kronen und Verblendwerkstoffe, für die der Hersteller angibt, dass sie an der Gerüststruktur ohne makro mechanische Retentionen, wie Perlen oder Drähte, haften.
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes (ISO 10477:2020)
Le présent document établit une classification des produits à base de polymères pour couronnes et facettes utilisés en médecine bucco‑dentaire, et spécifie les exigences qui leur sont applicables. Il spécifie également les méthodes d'essai à utiliser en vue de la détermination de leur conformité à ces exigences.
Le présent document est applicable aux produits à base de polymères pour couronnes et facettes destinés aux couronnes ou facettes permanentes fabriquées en laboratoire. Il s'applique également aux produits à base de polymères pour couronnes et facettes pour lesquels le fabricant revendique une adhérence à l'infrastructure sans rétention macromécanique, telle que les billes ou les fils.
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO 10477:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10477:2020
01-december-2020
Nadomešča:
SIST EN ISO 10477:2018
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO 10477:2020)
Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020)
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO 10477:2020)
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes
(ISO 10477:2020)
Ta slovenski standard je istoveten z: EN ISO 10477:2020
ICS:
11.060.10 Zobotehnični materiali Dental materials
SIST EN ISO 10477:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10477:2020
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SIST EN ISO 10477:2020
EN ISO 10477
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2020
EUROPÄISCHE NORM
ICS 11.060.10 Supersedes EN ISO 10477:2018
English Version
Dentistry - Polymer-based crown and veneering materials
(ISO 10477:2020)
Médecine bucco-dentaire - Produits à base de Zahnheilkunde - Polymerbasierte Kronen- und
polymères pour couronnes et facettes (ISO Verblendwerkstoffe (ISO 10477:2020)
10477:2020)
This European Standard was approved by CEN on 12 September 2020.
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
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10477:2020 E
worldwide for CEN national Members.
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SIST EN ISO 10477:2020
EN ISO 10477:2020 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 10477:2020
EN ISO 10477:2020 (E)
European foreword
This document (EN ISO 10477:2020) 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 May 2021, and conflicting national standards shall be
withdrawn at the latest by May 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 10477:2018.
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 10477:2020 has been approved by CEN as EN ISO 10477:2020 without any modification.
3
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SIST EN ISO 10477:2020
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SIST EN ISO 10477:2020
INTERNATIONAL ISO
STANDARD 10477
Fourth edition
2020-10
Dentistry — Polymer-based crown and
veneering materials
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Reference number
ISO 10477:2020(E)
©
ISO 2020
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SIST EN ISO 10477:2020
ISO 10477:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 10477:2020
ISO 10477:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General . 2
5.2 Depth of cure . 3
5.2.1 General. 3
5.2.2 Depth of cure, type 2, class 2 materials . 3
5.3 Surface finish . 3
5.4 Flexural strength . 3
5.5 Bond strength. 4
5.5.1 Special bonding system without macromechanical retention . 4
5.5.2 Values higher than 5 MPa . 4
5.6 Water sorption . 4
5.7 Solubility . 4
5.8 Shade consistency . 4
5.9 Colour stability . 4
5.10 Biocompatibility . 4
6 Sampling . 4
6.1 For all tests . 4
6.2 For test of shade consistency . 5
6.3 For test of colour stability . 5
7 Measurement and test methods . 5
7.1 General . 5
7.1.1 Test conditions. 5
7.1.2 Water . 5
7.1.3 Preparation of test specimens . 5
7.2 Visual inspection . 5
7.3 Depth of cure . 5
7.3.1 Apparatus . 5
7.3.2 Materials . 6
7.3.3 Procedure . 6
7.3.4 Expression of results . 6
7.4 Surface finish . 6
7.5 Flexural strength . 7
7.5.1 Apparatus . 7
7.5.2 Materials . 8
7.5.3 Preparation of test specimens . 8
7.5.4 Procedure . 9
7.5.5 Expression of results . 9
7.6 Bond strength.10
7.6.1 Apparatus .10
7.6.2 Materials .11
7.6.3 Preparation of test specimens .11
7.6.4 Procedure .12
7.6.5 Expression of results .13
7.7 Water sorption and solubility .13
7.7.1 Apparatus .13
7.7.2 Materials .14
© ISO 2020 – All rights reserved iii
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SIST EN ISO 10477:2020
ISO 10477:2020(E)
7.7.3 Preparation of test specimen .14
7.7.4 Procedure .14
7.7.5 Expression of results .15
7.8 Shade consistency and colour stability .16
7.8.1 General.16
7.8.2 Apparatus .16
7.8.3 Materials .16
7.8.4 Preparation of test specimens .17
7.8.5 Procedure .17
7.8.6 Colour comparison .17
7.8.7 Expression of results for shade consistency .17
7.8.8 Expression of results for colour stability .18
8 Packaging and labelling .18
8.1 Packaging .18
8.2 Labelling .18
8.2.1 General.18
8.2.2 Labelling of outer pack .18
8.2.3 Labelling of containers .18
9 Instructions for use .19
Bibliography .21
iv © ISO 2020 – All rights reserved
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SIST EN ISO 10477:2020
ISO 10477:2020(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 on 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 the following
URL: 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).
This fourth edition cancels and replaces the third edition (ISO 10477:2018), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— missing exemption condition for opaque resin test specimens in line 6 of Table 1 has been added;
— required number of specimen in 7.8 (Shade consistency and colour stability) has been corrected;
— several editorial changes have been made to describe the procedures more precisely;
— appropriate intervals for the storage times described in the procedures have been added.
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.
© ISO 2020 – All rights reserved v
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SIST EN ISO 10477:2020
ISO 10477:2020(E)
Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazards are not included in this document, but it is recommended that, for the assessment of
possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 10477:2020
INTERNATIONAL STANDARD ISO 10477:2020(E)
Dentistry — Polymer-based crown and veneering
materials
1 Scope
This document classifies polymer-based crown and veneering materials used in dentistry and specifies
their requirements. It also specifies the test methods to be used to determine conformity to these
requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated
permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials
for which the manufacturer claims adhesion to the substructure without macro-mechanical retention
such as beads or wires.
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, Water for analytical laboratory use — Specification and test methods
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7491, Dental materials — Determination of colour stability
ISO 8601 (all parts), Data elements and interchange formats — Information interchange — Representation
of dates and times
ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances
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
polymer-based crown and veneering material
composition of powders and liquids or pastes that may contain monomers, inorganic and/or polymeric
fillers and that, when polymerized, is suitable for use as permanent dental veneers or crowns
Note 1 to entry: Polymerization is effected by mixing initiator(s) and activator(s) (“self-curing” materials) and/
or by external energy activation [by heat (“heat-curing” materials), photoactivated materials, by visible light
(“light-curing” materials) and/or by UV radiation].
Note 2 to entry: The polymer-based crown and veneering materials for laboratory-fabricated permanent veneers
or crowns may or may not be attached to a substructure.
© ISO 2020 – All rights reserved 1
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SIST EN ISO 10477:2020
ISO 10477:2020(E)
3.2
dentine resin
pigmented and slightly translucent polymer-based crown and veneering material (3.1) that simulates the
natural appearance of dentine
3.3
enamel resin
translucent and slightly pigmented polymer-based crown and veneering material (3.1) that is packed in a
layer over the dentine resin and that simulates the natural appearance of enamel
3.4
cervical resin
intensely pigmented and slightly translucent polymer-based crown and veneering material (3.1) that
simulates the natural appearance of dentine of the cervical region of the tooth
3.5
opaque resin
intensely pigmented polymer-based crown and veneering material (3.1) applied in thin layers with the
purposes of completely masking the underlying material and bonding to it
Note 1 to entry: Opaque resins are only required to fulfil the requirement of 5.5.
4 Classification
The polymer-based crown and veneering materials described in this document shall be classified
according to their activation system for polymerization.
— Type 1: polymer-based crown and veneering materials whose setting is effected by mixing
initiator(s) and activator(s) (“self-curing” materials);
— Type 2: polymer-based crown and veneering materials whose setting is effected by the application
of energy from an external source (“external-energy-activated” materials), such as heat and/or
radiation (visible or UV range);
— Class 1: polymer-based crown and veneering materials that do not contain a photo-
polymerization initiator;
— Class 2: polymer-based crown and veneering materials that contain a photo-polymerization
initiator;
— Type 3: polymer-based crown and veneering materials whose setting is effected by mixing
initiator(s) and activator(s) and also by the application of energy from an external source (“dual-
cure” materials).
5 Requirements
5.1 General
The tests required for a crown and veneering material depend on the classification according to type
and class.
See Table 1 for the necessity of the specific tests described in 5.2 to 5.9.
2 © ISO 2020 – All rights reserved
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SIST EN ISO 10477:2020
ISO 10477:2020(E)
Table 1 — Test protocol
Subclause Property Type 1 Type 2 Type 3
Class 1 Class 2
a
5.2 Depth of cure — — + —
a a a a
5.3 Surface finish + + + +
a a a a
5.4 Flexural strength + + + +
5.5 Bond strength + + + +
a a a a
5.6 to 5.9 Water sorption, solubility, + + + +
shade consistency, colour
stability
+ carry out test;
— do not test.
a
If the material is opaque resin, do not test.
5.2 Depth of cure
5.2.1 General
Testing shall be carried out in accordance with 7.3.
5.2.2 Depth of cure, type 2, class 2 materials
For type 2, class 2 polymer-based crown and veneering materials, the hardness of the bottom surface
shall be not less than 70 % of that of the top surface (see Table 2).
For type 1, type 2, class 1 and type 3 materials, no requirement is specified. This requirement is not
applicable to opaque resins.
5.3 Surface finish
A test specimen polished in accordance with 7.4 shall have a glossy surface.
Testing shall be carried out in accordance with 7.4. This requirement is not applicable to opaque resins.
5.4 Flexural strength
The flexural strength shall be at least 50 MPa (see Table 2). This requirement is not applicable to
opaque resins.
Testing shall be carried out in accordance with 7.5.
Table 2 — Physical and chemical requirements
Subclause Property Requirement
5.2 Depth of cure Hardness of bottom surface ≥70 % of top surface
5.4 Flexural strength ≥50 MPa
5.5.1 Bond strength ≥5 MPa
5.5.2 ≥80 % of the value claimed
3
5.6 Water sorption ≤40 µg/mm
3
5.7 Solubility ≤7,5 µg/mm
© ISO 2020 – All rights
...
SLOVENSKI STANDARD
oSIST prEN ISO 10477:2020
01-marec-2020
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO/DIS 10477:2020)
Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2020)
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO/DIS
10477:2020)
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes
(ISO/DIS 10477:2020)
Ta slovenski standard je istoveten z: prEN ISO 10477
ICS:
11.060.10 Zobotehnični materiali Dental materials
oSIST prEN ISO 10477:2020 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 10477:2020
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oSIST prEN ISO 10477:2020
DRAFT INTERNATIONAL STANDARD
ISO/DIS 10477
ISO/TC 106/SC 2 Secretariat: ANSI
Voting begins on: Voting terminates on:
2020-01-28 2020-04-21
Dentistry — Polymer-based crown and veneering
materials
Médecine bucco-dentaire — Produits à base de polymères pour couronnes et facettes
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
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 10477:2020(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 2020
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oSIST prEN ISO 10477:2020
ISO/DIS 10477:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 10477:2020
ISO/DIS 10477:2020(E)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 2
5.1 General . 2
5.2 Depth of cure . 3
5.2.1 General. 3
5.2.2 Depth of cure, Type 2, Class 2 materials . 3
5.3 Surface finish . 3
5.4 Flexural strength . 3
5.5 Bond strength. 4
5.5.1 Special bonding system without macromechanical retention . 4
5.5.2 Values higher than 5 MPa . 4
5.6 Water sorption . 4
5.7 Solubility . 4
5.8 Shade consistency . 4
5.9 Colour stability . 4
5.10 Biocompatibility . 4
6 Sampling . 4
6.1 For all tests . 4
6.2 For test of shade consistency . 5
6.3 For test of colour stability . 5
7 Measurement and test methods . 5
7.1 General . 5
7.1.1 Test conditions. 5
7.1.2 Water . 5
7.1.3 Preparation of test specimens . 5
7.2 Visual inspection . 5
7.3 Depth of cure . 5
7.3.1 Apparatus . 5
7.3.2 Materials . 6
7.3.3 Procedure . 6
7.3.4 Expression of results . 6
7.4 Surface finish . 6
7.4.1 Apparatus . 7
7.4.2 Materials . 7
7.5 Flexural strength . 8
7.5.1 Apparatus . 8
7.5.2 Materials . 8
7.5.3 Preparation of test specimens . 9
7.5.4 Procedure .10
7.5.5 Expression of results .10
7.6 Bond strength.11
7.6.1 Apparatus .11
7.6.2 Materials .11
7.6.3 Preparation of test specimens .11
7.6.4 Procedure .12
7.6.5 Expression of results .13
7.7 Water sorption and solubility .13
© ISO 2020 – All rights reserved iii
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oSIST prEN ISO 10477:2020
ISO/DIS 10477:2020(E)
7.7.1 Apparatus .13
7.7.2 Materials .14
7.7.3 Preparation of test specimen .14
7.7.4 Procedure .14
7.7.5 Expression of results .15
7.8 Shade consistency and colour stability .16
7.8.1 General.16
7.8.2 Apparatus .16
7.8.3 Materials .16
7.8.4 Preparation of test specimens .17
7.8.5 Procedure .17
7.8.6 Colour comparison .17
7.8.7 Expression of results for shade consistency .17
7.8.8 Expression of results for colour stability .18
8 Packaging and labelling .18
8.1 Packaging .18
8.2 Labelling .18
8.2.1 General.18
8.2.2 Labelling of outer pack .18
8.2.3 Labelling of containers .18
9 Instructions for use .19
iv © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
oSIST prEN ISO 10477:2020
ISO/DIS 10477:2020(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 on 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 the following
URL: www .iso .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2,
Prosthodontic materials.
This fourth edition cancels and replaces the third edition (ISO 10477:2018), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— missing exemption condition for opaque resin test specimens in line 6 of Table 1 has been added;
— required number of specimen in 7.8 (Shade consistency and colour stability) has been corrected;
— several editorial changes to describe the procedures more precisely;
— addition of appropriate intervals for the storage times described in the procedures.
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.
© ISO 2020 – All rights reserved v
---------------------- Page: 7 ----------------------
oSIST prEN ISO 10477:2020
ISO/DIS 10477:2020(E)
Introduction
Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable
biological hazards are not included in this document, but it is recommended that, for the assessment of
possible biological hazards, reference should be made to ISO 10993-1 and ISO 7405.
vi © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
oSIST prEN ISO 10477:2020
DRAFT INTERNATIONAL STANDARD ISO/DIS 10477:2020(E)
Dentistry — Polymer-based crown and veneering
materials
1 Scope
This document classifies polymer-based crown and veneering materials used in dentistry and specifies
their requirements. It also specifies the test methods to be used to determine conformity to these
requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated
permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials
for which the manufacturer claims adhesion to the substructure without macro-mechanical retention
such as beads or wires.
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, Water for analytical laboratory use — Specification and test methods
ISO 6344-1, Coated abrasives — Grain size analysis — Part 1: Grain size distribution test
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7491, Dental materials — Determination of colour stability
ISO 8601, Data elements and interchange formats — Information interchange — Representation of dates
and times
ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances
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 https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
polymer-based crown and veneering material
composition of powders and liquids or pastes that may contain monomers, inorganic and/or polymeric
fillers and that, when polymerized, is suitable for use as permanent dental veneers or crowns
Note 1 to entry: Polymerization is effected by mixing initiator(s) and activator(s) (“self-curing” materials) and/
or by external energy activation [by heat (“heat-curing” materials), photoactivated materials, by visible light
(“light-curing” materials) and/or by UV radiation].
Note 2 to entry: The polymer-based crown and veneering materials for laboratory-fabricated permanent veneers
or crowns may or may not be attached to a substructure.
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3.2
dentine resin
pigmented and slightly translucent polymer-based crown and veneering material (3.1) that simulates the
natural appearance of dentine
3.3
enamel resin
translucent and slightly pigmented polymer-based crown and veneering material (3.1) that is packed in a
layer over the dentine resin and that simulates the natural appearance of enamel
3.4
cervical resin
intensely pigmented and slightly translucent polymer-based crown and veneering material (3.1) with a
colour that simulates the natural appearance of dentine of the cervical region of the tooth
3.5
opaque resin
intensely pigmented polymer-based crown and veneering material applied in thin layers with the
purposes of completely masking the underlying material and bonding to it
Note 1 to entry: Therefore opaque resins are only required to fulfil the requirement 5.5.
4 Classification
The polymer-based crown and veneering materials described in this document shall be classified
according to their activation system for polymerization.
— Type 1: polymer-based crown and veneering materials whose setting is effected by mixing
initiator(s) and activator(s) (“self-curing” materials);
— Type 2: polymer-based crown and veneering materials whose setting is effected by the application
of energy from an external source (“external-energy-activated” materials), such as heat and/or
radiation (visible or UV range);
— Class 1: polymer-based crown and veneering materials that do not contain a photo-
polymerization initiator;
— Class 2: polymer-based crown and veneering materials that contain a photo-polymerization
initiator;
— Type 3: polymer-based crown and veneering materials whose setting is effected by mixing
initiator(s) and activator(s) and also by the application of energy from an external source (“dual-
cure” materials).
5 Requirements
5.1 General
The tests required for a crown and veneering material depend on the classification according to Type
and Class.
See Table 1 for the necessity of the specific tests described in 5.2 to 5.9.
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Table 1 — Test protocol
Subclause Property Type 1 Type 2 Type 3
Class 1 Class 2
a
5.2 Depth of cure — — + —
a a a a
5.3 Surface finish + + + +
a a a a
5.4 Flexural strength + + + +
5.5 Bond strength + + + +
a a a a
5.6 to 5.9 Water sorption, solubility, + + + +
shade consistency, colour
stability
+ carry out test;
— do not test.
a
If the material is opaque resin, do not test.
5.2 Depth of cure
5.2.1 General
Testing shall be carried out in accordance with 7.3.
5.2.2 Depth of cure, Type 2, Class 2 materials
For Type 2, Class 2 polymer-based crown and veneering materials, the hardness of the bottom surface
shall be not less than 70 % of that of the top surface (see Table 2).
For Type 1, Type 2, Class 1 and Type 3 materials, no requirement is specified. This requirement is not
applicable to opaque resins.
5.3 Surface finish
A test specimen polished in accordance with 7.4 shall have a glossy surface.
Testing shall be carried out in accordance with 7.4. This requirement is not applicable to opaque resins.
5.4 Flexural strength
The flexural strength shall be at least 50 MPa (see Table 2). This requirement is not applicable to
opaque resins.
Testing shall be carried out in accordance with 7.5.
Table 2 — Physical and chemical requirements
Subclause Property Requirement
5.2 Depth of cure Hardness of bottom surface ≥70 % of top surface
5.4 Flexural strength ≥50 MPa
5.5.1 Bond strength ≥5 MPa
5.5.2 ≥80 % of the value claimed
3
5.6 Water sorption ≤40 µg/mm
3
5.7 Solubility ≤7,5 µg/mm
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5.5 Bond strength
5.5.1 Special bonding system without macromechanical retention
If the manufacturer recommends a special bonding system without macromechanical retention,
the strength of bond to the material used for the substructure shall be not less than 5 MPa (see
Tables 1 and 2).
Testing shall be carried out in accordance with 7.6.
5.5.2 Values higher than 5 MPa
If the manufacturer claims a value higher than 5 MPa for the bond strength, then the bond strength
shall be not less than 80 % of the value claimed.
Testing shall be carried out in accordance with 7.6.
5.6 Water sorption
The water sorption of the cured polymer-based crown and veneering material shall be not more than
3
40 µg/mm (see Table 2).
Testing shall be carried out in accordance with 7.7. This requirement is not applicable to opaque resins.
5.7 Solubility
The solubility in water of the cured polymer-based crown and veneering material shall be not more
3
than 7,5 µg/mm (see Table 2).
Testing shall be carried out in accordance with 7.7. This requirement is not applicable to opaque resins.
5.8 Shade consistency
The colours of the cured polymer-based crown and veneering material from different batches
(according to 6.1 and 6.2) shall show no more than a slight difference with the colour indicated by the
manufacturer.
Testing shall be carried out in accordance with 7.8 and ISO 7491. This requirement is not applicable to
opaque resins.
5.9 Colour stability
The polymer-based crown and veneering material shall show no more than a slight change in colour.
Testing shall be carried out in accordance with 7.8 and ISO 7491. This requirement is not applicable to
opaque resins.
5.10 Biocompatibility
See Introduction for guidance on biocompatibility.
6 Sampling
6.1 For all tests
The test sample shall consist of one or more packages of one selected shade, corresponding to the
purpose of the test, from a single batch and contain sufficient (approximately 20 ml) material to carry
out the specified tests, plus an allowance for any necessary repetition of tests.
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6.2 For test of shade consistency
The sample for the test of shade consistency (5.8 and 7.8) shall consist of the same shade as in 6.1
(approximately 1 ml) but from another batch.
6.3 For test of colour stability
The sample for the test of colour stability (5.9 and 7.8) shall consist of two further shades of the material.
The shade of the resin sample shall consist of three different shades each of which correspond to one
representative shade of enamel, dentine and cervical resin (approximately 1 ml for each shade).
7 Measurement and test methods
7.1 General
7.1.1 Test conditions
Test specimens shall be prepared and tested at (23 ± 2) °C
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