Dentistry — Polymer-based crown and veneering materials

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.

Médecine bucco-dentaire — Produits à base de polymères pour couronnes et facettes

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.

General Information

Status
Published
Publication Date
25-Oct-2020
Current Stage
6060 - International Standard published
Start Date
26-Oct-2020
Completion Date
26-Oct-2020
Ref Project

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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
---------------------- Page: 1 ----------------------
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
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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: 2 ----------------------
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

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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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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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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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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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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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ISO 10477:2020(E)
Table 1 — Test protocol
Subclause Property Type 1 Type 2 Type 3
Class 1 Class 2
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.
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
5.6 Water sorption ≤40 µg/mm
5.7 Solubility ≤7,5 µg/mm
© ISO 2020 – All rights reserved 3
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ISO 10477:2020(E)
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

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

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
Refer to the 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.

4 © ISO 2020 – All rights reserved
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ISO 10477:2020(E)
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 resin, dentine resin and cervical resin (approximately 1 ml for

each shade). They should be selected in consideration of its colouring components, if different colouring

components are used.
7 Measurement and test methods
7.1 General
7.1.1 Test conditions

Test specimens shall be prepared and tested at (23 ± 2) °C. The relative humidity shall be not less

than 30 %.
7.1.2 Water

Unless otherwise specified, the water to be used shall conform to ISO 3696:1987, Grade 3.

7.1.3 Preparation of test specimens

For the preparation of type 2 and type 3 polymer-based crown and veneering materials, reference

shall be made to the instruction for use [see Clause 9, p) and q)] that state the external energy source

or sources recommended for the materials to be tested. Care shall be taken to ensure that the energy

source is fully functional.

Mix or otherwise prepare the polymer-based crown and veneering material in accordance with the

instruction for use and the test conditions specified in 7.1.1.
Use only the quantity required to prepare one of the corresponding specimens.

If fully cured specimens are required for testing (7.4 to 7.8), it is important to ensure that the specimens

are homogeneous after removal from the mould. There shall be no voids, clefts or air inclusions present

by visual inspection without magnification.

A separating medium which does not interfere with the setting reaction (e.g. 3 % solution of

polyvinylstearyl ether wax in hexane) may be used to facilitate removal of the specimen.

7.2 Visual inspection

Use visual inspection to determine conformity to Clauses 8 and 9. The colour comparison in 7.8 shall be

performed in accordance with ISO 7491.
7.3 Depth of cure
7.3.1 Apparatus

7.3.1.1 Split rings, such as shown in Figure 1, (15 ± 1) mm in diameter and (1 ± 0,1) mm in height.

© ISO 2020 – All rights reserved 5
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ISO 10477:2020(E)

7.3.1.2 Two plates (e.g. polished metal or glass), measuring approximately 20 mm × 20 mm × 5 mm.

7.3.1.3 Radiation source, as recommended in the instructions for use.
...

NORME ISO
INTERNATIONALE 10477
Quatrième édition
2020-10
Médecine bucco-dentaire — Produits
à base de polymères pour couronnes
et facettes
Dentistry — Polymer-based crown and veneering materials
Numéro de référence
ISO 10477:2020(F)
ISO 2020
---------------------- Page: 1 ----------------------
ISO 10477:2020(F)
DOCUMENT PROTÉGÉ PAR COPYRIGHT
© ISO 2020

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publication ne peut être reproduite ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique,

y compris la photocopie, ou la diffusion sur l’internet ou sur un intranet, sans autorisation écrite préalable. Une autorisation peut

être demandée à l’ISO à l’adresse ci-après ou au comité membre de l’ISO dans le pays du demandeur.

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Publié en Suisse
ii © ISO 2020 – Tous droits réservés
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ISO 10477:2020(F)
Sommaire Page

Avant-propos ................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Domaine d’application ................................................................................................................................................................................... 1

2 Références normatives ................................................................................................................................................................................... 1

3 Termes et définitions ....................................................................................................................................................................................... 1

4 Classification ............................................................................................................................................................................................................ 2

5 Exigences ...................................................................................................................................................................................................................... 3

5.1 Généralités .................................................................................................................................................................................................. 3

5.2 Profondeur de polymérisation .................................................................................................................................................. 3

5.2.1 Généralités ............................................................................................................................................................................ 3

5.2.2 Profondeur de polymérisation des produits de type 2, classe 2............................................. 3

5.3 Fini de surface.......................................................................................................................................................................................... 3

5.4 Résistance à la flexion ....................................................................................................................................................................... 3

5.5 Force d’adhésion .................................................................................................................................................................................... 4

5.5.1 Système de collage spécial sans rétention macromécanique .................................................... 4

5.5.2 Valeurs supérieures à 5 MPa ................................................................................................................................. 4

5.6 Absorption d’eau ................................................................................................................................................................................... 4

5.7 Solubilité ....................................................................................................................................................................................................... 4

5.8 Uniformité de la teinte ...................................................................................................................................................................... 4

5.9 Stabilité de la couleur ........................................................................................................................................................................ 4

5.10 Biocompatibilité..................................................................................................................................................................................... 5

6 Échantillonnage ..................................................................................................................................................................................................... 5

6.1 Pour tous les essais ............................................................................................................................................................................. 5

6.2 Pour l’essai d’uniformité de la teinte ................................................................................................................................... 5

6.3 Pour l’essai de stabilité de la couleur .................................................................................................................................. 5

7 Mesurage et méthodes d’essai................................................................................................................................................................ 5

7.1 Généralités .................................................................................................................................................................................................. 5

7.1.1 Conditions d’essai ........................................................................................................................................................... 5

7.1.2 Eau .................. ......................................................................................................................... ..................................................... 5

7.1.3 Préparation des éprouvettes ................................................................................................................................. 5

7.2 Examen visuel .......................................................................................................................................................................................... 6

7.3 Profondeur de polymérisation .................................................................................................................................................. 6

7.3.1 Appareillage ......................................................................................................................................................................... 6

7.3.2 Matériaux ............................................................................................................................................................................... 6

7.3.3 Mode opératoire ............................................................................................................................................................... 6

7.3.4 Expression des résultats ........................................................................................................................................... 7

7.4 Fini de surface.......................................................................................................................................................................................... 7

7.5 Résistance à la flexion ....................................................................................................................................................................... 8

7.5.1 Appareillage ......................................................................................................................................................................... 8

7.5.2 Matériaux ............................................................................................................................................................................... 9

7.5.3 Préparation des éprouvettes ..............................................................................................................................10

7.5.4 Mode opératoire ............................................................................................................................................................10

7.5.5 Expression des résultats ........................................................................................................................................11

7.6 Force d’adhésion .................................................................................................................................................................................11

7.6.1 Appareillage ......................................................................................................................................................................11

7.6.2 Matériaux ............................................................................................................................................................................12

7.6.3 Préparation des éprouvettes ..............................................................................................................................12

7.6.4 Mode opératoire ............................................................................................................................................................13

7.6.5 Expression des résultats ........................................................................................................................................14

7.7 Absorption d’eau et solubilité .................................................................................................................................................14

7.7.1 Appareillage ......................................................................................................................................................................14

7.7.2 Matériaux ............................................................................................................................................................................15

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ISO 10477:2020(F)

7.7.3 Préparation de l’éprouvette ................................................................................................................................15

7.7.4 Mode opératoire ............................................................................................................................................................15

7.7.5 Expression des résultats ........................................................................................................................................16

7.8 Uniformité de la teinte et stabilité de la couleur ....................................................................................................17

7.8.1 Généralités .........................................................................................................................................................................17

7.8.2 Appareillage ......................................................................................................................................................................17

7.8.3 Matériaux ............................................................................................................................................................................18

7.8.4 Préparation des éprouvettes ..............................................................................................................................18

7.8.5 Mode opératoire ............................................................................................................................................................18

7.8.6 Comparaison des couleurs ...................................................................................................................................18

7.8.7 Expression des résultats d’uniformité de la teinte ..........................................................................19

7.8.8 Expression des résultats de stabilité de la couleur .........................................................................19

8 Emballage et étiquetage ............................................................................................................................................................................19

8.1 Emballage .................................................................................................................................................................................................19

8.2 Étiquetage ................................................................................................................................................................................................19

8.2.1 Généralités .........................................................................................................................................................................19

8.2.2 Étiquetage de l’emballage extérieur ............................................................................................................19

8.2.3 Étiquetage des conteneurs ...................................................................................................................................20

9 Instructions d’utilisation ..........................................................................................................................................................................20

Bibliographie ...........................................................................................................................................................................................................................22

iv © ISO 2020 – Tous droits réservés
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ISO 10477:2020(F)
Avant-propos

L’ISO (Organisation internationale de normalisation) est une fédération mondiale d’organismes

nationaux de normalisation (comités membres de l’ISO). L’élaboration des Normes internationales est

en général confiée aux comités techniques de l’ISO. Chaque comité membre intéressé par une étude

a le droit de faire partie du comité technique créé à cet effet. Les organisations internationales,

gouvernementales et non gouvernementales, en liaison avec l’ISO participent également aux travaux.

L’ISO collabore étroitement avec la Commission électrotechnique internationale (IEC) en ce qui

concerne la normalisation électrotechnique.

Les procédures utilisées pour élaborer le présent document et celles destinées à sa mise à jour sont

décrites dans les Directives ISO/IEC, Partie 1. Il convient, en particulier de prendre note des différents

critères d’approbation requis pour les différents types de documents ISO. Le présent document a été

rédigé conformément aux règles de rédaction données dans les Directives ISO/IEC, Partie 2 (voir www

.iso .org/ directives).

L’attention est attirée sur le fait que certains des éléments du présent document peuvent faire l’objet de

droits de propriété intellectuelle ou de droits analogues. L’ISO ne saurait être tenue pour responsable

de ne pas avoir identifié de tels droits de propriété et averti de leur existence. Les détails concernant

les références aux droits de propriété intellectuelle ou autres droits analogues identifiés lors de

l’élaboration du document sont indiqués dans l’Introduction et/ou dans la liste des déclarations de

brevets reçues par l’ISO (voir www .iso .org/ brevets).

Les appellations commerciales éventuellement mentionnées dans le présent document sont données

pour information, par souci de commodité, à l’intention des utilisateurs et ne sauraient constituer un

engagement.

Pour une explication de la nature volontaire des normes, la signification des termes et expressions

spécifiques de l’ISO liés à l’évaluation de la conformité, ou pour toute information au sujet de l’adhésion

de l’ISO aux principes de l’Organisation mondiale du commerce (OMC) concernant les obstacles

techniques au commerce (OTC), voir le lien suivant: www .iso .org/ iso/ fr/ avant-propos.

Le présent document a été élaboré par le Comité technique ISO/TC 106, Médecine bucco-dentaire,

sous-comité SC 2, Produits pour prothèses dentaires, en collaboration le Comité technique CEN/TC 55,

Médecine bucco-dentaire, du Comité européen de normalisation (CEN), conformément à l’Accord de

coopération technique entre l’ISO et le CEN (Accord de Vienne).

Cette quatrième édition annule et remplace la troisième édition (ISO 10477:2018), qui a fait l’objet d’une

révision technique.

Les principales modifications par rapport à l’édition précédente sont les suivantes:

— ajout de la condition d’exemption manquante pour les éprouvettes de résine opaque à la ligne 6 du

Tableau 1;

— correction du nombre requis d’éprouvettes en 7.8 (Uniformité de la teinte et stabilité de la couleur);

— intégration de plusieurs modifications rédactionnelles pour décrire les modes opératoires avec plus

de précision;

— ajout d’intervalles appropriés pour les durées de stockage décrites dans les modes opératoires.

Il convient que l’utilisateur adresse tout retour d’information ou toute question concernant le présent

document à l’organisme national de normalisation de son pays. Une liste exhaustive desdits organismes

se trouve à l’adresse www .iso .org/ fr/ members .html.
© ISO 2020 – Tous droits réservés v
---------------------- Page: 5 ----------------------
ISO 10477:2020(F)
Introduction

Le présent document ne comporte aucune méthode d’essai qualitative ou quantitative spécifique

pour démontrer l’absence de risques biologiques inacceptables. Il est recommandé de se référer à

l’ISO 10993-1 et à l’ISO 7405 pour l’évaluation des risques biologiques potentiels.

vi © ISO 2020 – Tous droits réservés
---------------------- Page: 6 ----------------------
NORME INTERNATIONALE ISO 10477:2020(F)
Médecine bucco-dentaire — Produits à base de polymères
pour couronnes et facettes
1 Domaine d’application

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.

2 Références normatives

Les documents suivants sont cités dans le texte de sorte qu’ils constituent, pour tout ou partie de leur

contenu, des exigences du présent document. Pour les références datées, seule l’édition citée s’applique.

Pour les références non datées, la dernière édition du document de référence s’applique (y compris les

éventuels amendements).
ISO 1942, Médecine bucco-dentaire — Vocabulaire

ISO 3696, Eau pour laboratoire à usage analytique — Spécification et méthodes d’essai

ISO 6344-1, Abrasifs appliqués — Granulométrie — Partie 1: Contrôle de la distribution granulométrique

ISO 6507-1, Matériaux métalliques — Essai de dureté Vickers — Partie 1: Méthode d’essai

ISO 7491, Produits dentaires — Détermination de la stabilité de couleur

ISO 8601 (toutes les parties), Date et heure — Représentations pour l’échange d’information

ISO 22674, Médecine bucco‑dentaire — Matériaux métalliques pour les restaurations fixes et amovibles et

les appareillages
3 Termes et définitions

Pour les besoins du présent document, les termes et définitions de l’ISO 1942 s’appliquent.

L’ISO et l’IEC tiennent à jour des bases de données terminologiques destinées à être utilisées en

normalisation, consultables aux adresses suivantes:

— ISO Online browsing platform: disponible à l’adresse https:// www .iso .org/ obp;

— IEC Electropedia: disponible à l’adresse http:// www .electropedia .org/ .
© ISO 2020 – Tous droits réservés 1
---------------------- Page: 7 ----------------------
ISO 10477:2020(F)
3.1
produit à base de polymère pour couronnes et facettes

mélange de poudres et de liquides ou de pâtes qui peut contenir des monomères, des charges

polymériques et/ou minérales qui, une fois polymérisé, est apte à l’utilisation comme couronnes ou

facettes permanentes

Note 1 à l'article: La polymérisation s’effectue par mélange d’un ou plusieurs initiateurs et d’un ou plusieurs

activateurs (autopolymérisation) et/ou par l’application d’une énergie d’activation extérieure [par la chaleur

(polymérisation thermique), par photoactivation, par activation par la lumière visible (photopolymérisation) et/

ou par un rayonnement ultraviolet].

Note 2 à l'article: Les produits à base de polymères pour couronnes et facettes destinés aux couronnes ou facettes

permanentes fabriquées en laboratoire sont susceptibles ou non d’être fixées à une infrastructure.

3.2
résine dentinaire

produit à base de polymère pour couronnes et facettes (3.1), pigmenté et légèrement transparent, qui

simule l’aspect naturel de la dentine
3.3
résine amélaire

produit à base de polymère pour couronnes et facettes (3.1), translucide et légèrement pigmenté, appliqué

en une couche sur la résine dentinaire pour simuler l’aspect naturel de l’émail
3.4
résine cervicale

produit à base de polymère pour couronnes et facettes (3.1), très pigmenté et légèrement translucide, qui

simule l’aspect naturel de la dentine de la partie cervicale de la dent
3.5
résine opaque

produit à base de polymère pour couronnes et facettes (3.1) très pigmenté, appliqué en couches minces

pour masquer entièrement le matériau sous-jacent et y adhérer

Note 1 à l'article: Les résines opaques doivent uniquement remplir l’exigence de 5.5.

4 Classification

Les produits à base de polymères pour couronnes et facettes décrits dans le présent document doivent

être classés en fonction de leur système d’activation de la polymérisation:

— Type 1: produits à base de polymères pour couronnes et facettes dont la prise est activée par le

mélange d’un ou plusieurs initiateurs et d’un ou plusieurs activateurs (autopolymérisation);

— Type 2: produits à base de polymères pour couronnes et facettes dont la prise est activée par

l’application d’une énergie provenant d’une source extérieure (activation extérieure) telle que la

chaleur et/ou la lumière ou le rayonnement (visible ou ultraviolet);

— Classe 1: produits à base de polymères pour couronnes et facettes qui ne contiennent pas

d’initiateur de photopolymérisation;

— Classe 2: produits à base de polymères pour couronnes et facettes qui contiennent un initiateur

de photopolymérisation;

— Type 3: produits à base de polymères pour couronnes et facettes dont la prise est activée par le

mélange d’un ou plusieurs initiateurs et d’un ou plusieurs activateurs, mais aussi par l’application

d’une énergie provenant d’une source extérieure (polymérisation duale).
2 © ISO 2020 – Tous droits réservés
---------------------- Page: 8 ----------------------
ISO 10477:2020(F)
5 Exigences
5.1 Généralités

Les essais exigés pour un produit pour couronnes et facettes dépendent de la classification de ce dernier

(type et classe).

Voir le Tableau 1 pour les indications sur la nécessité de réaliser les essais spécifiques décrits de 5.2 à 5.9.

Tableau 1 — Protocole d’essai
Paragraphe Propriété Type 1 Type 2 Type 3
Classe 1 Classe 2
5.2 Profondeur de polymérisa- — — + —
tion
a a a a
5.3 Fini de surface + + + +
a a a a
5.4 Résistance à la flexion + + + +
5.5 Force d’adhésion + + + +
a a a a
5.6 à 5.9 Absorption d’eau, solubi- + + + +
lité, uniformité de la teinte,
stabilité de la couleur
+ Réaliser l’essai.
— Ne pas réaliser l’essai.
Ne pas réaliser l’essai si le produit est une résine opaque.
5.2 Profondeur de polymérisation
5.2.1 Généralités
L’essai doit être réalisé conformément à 7.3.
5.2.2 Profondeur de polymérisation des produits de type 2, classe 2

Pour les produits à base de polymères pour couronnes et facettes de type 2, classe 2, la dureté de la

surface inférieure ne doit pas être inférieure à 70 % de celle de la surface supérieure (voir Tableau 2).

Aucune exigence n’est spécifiée pour le type 1, le type 2, classe 1, ni pour le type 3. Cette exigence n’est

pas applicable aux résines opaques.
5.3 Fini de surface
La surface d’une éprouvette polie conformément à 7.4 doit être brillante.

L’essai doit être réalisé conformément à 7.4. Cette exigence n’est pas applicable aux résines opaques.

5.4 Résistance à la flexion

La résistance à la flexion doit être au moins égale à 50 MPa (voir Tableau 2). Cette exigence n’est pas

applicable aux résines opaques.
L’essai doit être réalisé conformément à 7.5.
© ISO 2020 – Tous droits réservés 3
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ISO 10477:2020(F)
Tableau 2 — Exigences relatives aux propriétés physiques et chimiques
Paragraphe Propriété Exigence
Profondeur de polymérisa- Dureté de la surface inférieure ≥70 % de celle de
5.2
tion la surface supérieure
5.4 Résistance à la flexion ≥50 MPa
5.5.1 Force d’adhésion ≥5 MPa
5.5.2 ≥80 % de la valeur déclarée
5.6 Absorption d’eau ≤40 µg/mm
5.7 Solubilité ≤7,5 µg/mm
5.5 Force d’adhésion
5.5.1 Système de collage spécial sans rétention macromécanique

Si le fabricant recommande un système de collage spécial sans rétention macromécanique, la force

d’adhésion au matériau d’infrastructure ne doit pas être inférieure à 5 MPa (voir Tableaux 1 et 2).

L’essai doit être réalisé conformément à 7.6.
5.5.2 Valeurs supérieures à 5 MPa

Si le fabricant déclare une valeur supérieure à 5 MPa pour la force d’adhésion, cette force ne doit pas

être inférieure à 80 % de la valeur déclarée.
L’essai doit être réalisé conformément à 7.6.
5.6 Absorption d’eau

L’absorption d’eau par les produits pour couronnes et facettes polymérisés ne doit pas dépasser 40 µg/

mm (voir Tableau 2).

L’essai doit être réalisé conformément à 7.7. Cette exigence n’est pas applicable aux résines opaques.

5.7 Solubilité

La solubilité dans l’eau des produits pour couronnes et facettes polymérisés ne doit pas être supérieure

à 7,5 µg/mm (voir Tableau 2).

L’essai doit être réalisé conformément à 7.7. Cette exigence n’est pas applicable aux résines opaques.

5.8 Uniformité de la teinte

La couleur des produits pour couronnes et facettes polymérisés issus de lots différents (selon 6.1 et 6.2)

ne doit présenter qu’une faible différence par rapport à la couleur indiquée par le fabricant.

L’essai doit être réalisé conformément à 7.8 et à l’ISO 7491. Cette exigence n’est pas applicable aux

résines opaques.
5.9 Stabilité de la couleur

Les produits à base de polymères pour couronnes et facettes ne doivent présenter qu’une faible

variation de couleur.

L’essai doit être réalisé conformément à 7.8 et à l’ISO 7491. Cette exigence n’est pas applicable aux

résines opaques.
4 © ISO 2020 – Tous droits réservés
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ISO 10477:2020(F)
5.10 Biocompatibilité
Voir l’Introduction pour les recommandations relatives à la biocompatibilité.
6 Échantillonnage
6.1 Pour tous les essais

L’échantillon pour essai doit comprendre un ou plusieurs produits conditionnés d’une teinte choisie, selon

les besoins de l’essai, issu(s) d’un seul et même lot, et doit contenir suffisamment de produit (environ

20 ml) pour qu’il soit possible d’effectuer les essais spécifiés et, si nécessaire, de répéter ces essais.

6.2 Pour l’essai d’uniformité de la teinte

L’échantillon pour l’essai d’uniformité de la teinte (5.8 et 7.8) doit être de la même teinte qu’en 6.1

(environ 1 ml), mais issu d’un autre lot.
6.3 Pour l’essai de stabilité de la couleur

L’échantillon pour l’essai de stabilité de la couleur (5.9 et 7.8) doit comprendre deux autres teintes

du produit. La teinte de l’échantillon de résine doit comprendre trois teintes différentes, chacune

correspondant à une teinte représentative de résine amélaire, résine dentinaire et résine cervicale

(environ 1 ml pour chaque teinte). Il convient de les sélectionner en fonction de leurs colorants, si

différents colorants sont utilisés.
7 Mesurage et méthodes d’essai
7.1 Généralités
7.1.1 Conditions d’essai

Les éprouvettes doivent être préparées et soumises à essai à (23 ± 2) °C. L’humidité relative ne doit pas

être inférieure à 30 %.
7.1.2 Eau

Sauf spécification contraire, l’eau utilisée doit être conforme à l’ISO 3696:1987, qualité 3.

7.1.3 Préparation des éprouvettes

Pour préparer des produits à base de polymères pour couronnes et facettes de type 2 et de type 3,

il faut se référer aux instructions d’utilisation [voir Article 9, p) et q)] qui indiquent la

...

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
---------------------- Page: 1 ----------------------
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
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Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
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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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
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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
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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
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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.
© ISO 2020 – All rights reserved 1
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ISO/DIS 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) 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
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.
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
5.6 Water sorption ≤40 µg/mm
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

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

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. The relative humidity shall be not less

than 30 %.
7.1.2 Water

Unless otherwise specified, the water to be used shall conform to ISO 3696, Grade 3.

7.1.3 Preparation of test specimens

For the preparation of Type 2 and Type 3 polymer-based crown and veneering materials, reference shall

be made to the instruction for use [see 9 p) and q)] that state the external energy source or sources

recommended for the materials to be tested. Care shall be taken to ensure that the energy source is

fully functional.

Mix or otherwise prepare the polymer-based crown and veneering material in accordance with the

instruction for use and the test conditions specified in 7.1.1.
Use only the quantity required to prepare one of the corresponding specimens.

If fully cured specimens are required for testing (7.4 to 7.8), it is important to ensure that the specimens

are homogeneous after removal from the mould. There shall be no voids, clefts or air inclusions present

by visual inspection without magnification.
A separating medium which does not interfere with the setting reaction (e
...

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