SIST EN ISO 10477:2020

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
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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
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oSIST prEN ISO 10477:2020
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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
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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
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oSIST prEN ISO 10477:2020
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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.
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oSIST prEN ISO 10477:2020
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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.
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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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oSIST prEN ISO 10477:2020
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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
...