oSIST prEN ISO 10477:2025
(Main)Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2025)
Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2025)
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO/DIS 10477:2025)
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes (ISO/DIS 10477:2025)
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO/DIS 10477:2025)
General Information
- Status
- Not Published
- Public Enquiry End Date
- 30-May-2025
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 4020 - Public enquire (PE) (Adopted Project)
- Start Date
- 20-Mar-2025
- Due Date
- 07-Aug-2025
- Completion Date
- 02-Jun-2025
Relations
- Revises
SIST EN ISO 10477:2020 - Dentistry - Polymer-based crown and veneering materials (ISO 10477:2020) - Effective Date
- 02-Nov-2022
Overview
The draft international standard oSIST prEN ISO 10477:2025:2025 issued by CEN addresses specifications for polymer-based crown and veneering materials in dentistry. Developed under ISO/TC 106/SC 2 with ANSI as the secretariat, this standard sets technical requirements and test methods for polymeric materials used to fabricate crowns, bridges, and veneering facings. These materials play a crucial role in restorative dental treatments, providing esthetic, functional, and biocompatible solutions. The standard aims to ensure consistent performance, safety, and quality for dental professionals and manufacturers worldwide.
Key Topics
oSIST prEN ISO 10477:2025:2025 covers a comprehensive scope of critical aspects including:
- Material Classification: Defining categories and types of polymer-based crown and veneering materials.
- Performance Requirements:
- Depth of Cure: Ensures sufficient polymerization in materials to guarantee durability.
- Surface Finish: Standards for smoothness and polishability critical to patient comfort and plaque resistance.
- Flexural Strength: Measurement of resistance to bending forces, ensuring restoration longevity.
- Bond Strength: Evaluation of adhesion between the polymer material and tooth substrates or frameworks.
- Water Sorption and Solubility: Limits on moisture absorption and dissolution to prevent degradation.
- Shade Consistency and Color Stability: Critical for esthetic dental restorations to maintain appearance over time.
- Sampling and Testing Methods: Detailed procedures for preparing specimens, conducting tests, and expressing results.
- Packaging and Labelling: Requirements for proper product information and handling instructions.
The document also highlights the importance of controlled ambient test conditions, use of standardized apparatus, and precise measurement techniques to guarantee reproducibility and comparability of results.
Applications
This standard is of prime importance for:
- Dental Materials Manufacturers: To design and produce polymer-based crowns and veneering materials meeting international quality and safety criteria.
- Dental Laboratories: To select compliant materials that fulfill esthetic and mechanical demands in fabrication workflows.
- Dental Practitioners and Prosthodontists: For confidence in material performance when restoring patients' dental structures.
- Regulatory Bodies: Offering a benchmark for approval and market surveillance of polymer dental restorative materials.
- Research and Development: Supporting innovation by providing reference test methods and material specification frameworks.
By adhering to oSIST prEN ISO 10477:2025:2025, the dental industry can enhance patient outcomes, extend prosthesis service life, and reduce failure rates.
Related Standards
oSIST prEN ISO 10477:2025:2025 complements and aligns with existing dental material standards including:
- ISO 6872 – Dental Ceramic Materials – covering ceramics used in dental restorations.
- ISO 4049 – Polymer-based restorative materials – focusing on direct restorative composites.
- ISO 10993 – Biological Evaluation of Medical Devices – ensuring biocompatibility.
- ISO 14801 – Dental Implants-Fatigue testing – relevant for polymer-based implant components.
- CEN EN 1641 – Dental base polymers and polymer materials – harmonized European standards.
Together, these standards create a holistic set of requirements spanning all major classes of dental restorative materials, ensuring global consistency and safety in dental care.
For manufacturers, dental labs, and clinical users, oSIST prEN ISO 10477:2025:2025 provides essential guidance on the performance, testing, and labelling of polymer-based crowns and veneering materials, establishing a robust framework to support high-quality and safe dental restorations.
Frequently Asked Questions
oSIST prEN ISO 10477:2025 is a draft published by the Slovenian Institute for Standardization (SIST). Its full title is "Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2025)". This standard covers: Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2025)
Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2025)
oSIST prEN ISO 10477:2025 is classified under the following ICS (International Classification for Standards) categories: 11.060.10 - Dental materials. The ICS classification helps identify the subject area and facilitates finding related standards.
oSIST prEN ISO 10477:2025 has the following relationships with other standards: It is inter standard links to SIST EN ISO 10477:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
oSIST prEN ISO 10477:2025 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2025
Zobozdravstvo - Polimerni materiali za prevleke in mostičke (ISO/DIS 10477:2025)
Dentistry - Polymer-based crown and veneering materials (ISO/DIS 10477:2025)
Zahnheilkunde - Polymerbasierte Kronen- und Verblendwerkstoffe (ISO/DIS
10477:2025)
Médecine bucco-dentaire - Produits à base de polymères pour couronnes et facettes
(ISO/DIS 10477:2025)
Ta slovenski standard je istoveten z: prEN ISO 10477
ICS:
11.060.10 Zobotehnični materiali Dental materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 10477
ISO/TC 106/SC 2
Dentistry — Polymer-based crown
Secretariat: ANSI
and veneering materials
Voting begins on:
Médecine bucco-dentaire — Produits à base de polymères pour
2025-03-10
couronnes et facettes
Voting terminates on:
ICS: 11.060.10 2025-06-02
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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.
Reference number
ISO/DIS 10477:2025(en)
DRAFT
ISO/DIS 10477:2025(en)
International
Standard
ISO/DIS 10477
ISO/TC 106/SC 2
Dentistry — Polymer-based crown
Secretariat: ANSI
and veneering materials
Voting begins on:
Médecine bucco-dentaire — Produits à base de polymères pour
couronnes et facettes
Voting terminates on:
ICS: 11.060.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
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or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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Published in Switzerland Reference number
ISO/DIS 10477:2025(en)
ii
ISO/DIS 10477:2025(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Classification . 2
5 Requirements . 3
5.1 General .3
5.2 Depth of cure .3
5.2.1 General .3
5.2.2 Depth of cure (only type 2 class 2 materials) .4
5.3 Surface finish .4
5.4 Flexural strength.4
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 .5
5.8 Shade consistency .5
5.9 Colour stability .5
6 Sampling . 5
6.1 For all tests.5
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 Ambient test conditions .5
7.1.2 Water .6
7.1.3 Preparation of test specimens .6
7.2 Visual inspection .6
7.3 Depth of cure (only for type 2, class 2 if not opaque resin) .6
7.3.1 Apparatus .6
7.3.2 Materials .6
7.3.3 Procedure .7
7.3.4 Expression of results .7
7.4 Surface finish .7
7.4.1 Apparatus (for type 2 class 3 and type 4 materials) .7
7.4.2 Specimen preparation .7
7.4.3 Surface polishing .8
7.5 Flexural strength.9
7.5.1 Apparatus .9
7.5.2 Materials .10
7.5.3 Preparation of test specimens .11
7.5.4 Procedure . 12
7.5.5 Expression of results . 12
7.6 Bond strength (only type 1, type 2 classes 1 and 2, and type 3 materials), . 13
7.6.1 Apparatus . 13
7.6.2 Materials . 13
7.6.3 Preparation of test specimens . 13
7.6.4 Procedure .14
7.6.5 Expression of results . 15
7.7 Water sorption and solubility . 15
iii
ISO/DIS 10477:2025(en)
7.7.1 Apparatus . 15
7.7.2 Materials .16
7.7.3 Preparation of test specimen .16
7.7.4 Procedure .17
7.7.5 Expression of results .17
7.8 Shade consistency and colour stability .18
7.8.1 General .18
7.8.2 Apparatus .19
7.8.3 Materials .19
7.8.4 Preparation of test specimens .19
7.8.5 Procedure . 20
7.8.6 Colour comparison. 20
7.8.7 Expression of results for shade consistency . . 20
7.8.8 Expression of results for colour stability . 20
8 Packaging and labelling .21
8.1 Packaging .21
8.2 Labeling and instructions for use .21
Bibliography .24
iv
ISO/DIS 10477:2025(en)
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 fifth edition cancels and replaces the fourth edition (ISO 10477:2020), which has been technically
revised.
The main changes compared to the previous edition are as follows:
— addition of printed materials in Clause 4 as Type 2 Class 3;
— addition of milled materials in Clause 4 as Type 4.
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.
v
ISO/DIS 10477:2025(en)
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
DRAFT International Standard ISO/DIS 10477:2025(en)
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 6344-2, Coated abrasives — Determination and designation of grain size distribution — Part 2: Macrogrit
sizes P12 to P220
ISO 6344-3, Coated abrasives — Determination and designation of grain size distribution — Part 3: Microgrit
sizes P240 to P5000
ISO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method
ISO 7491, Dental materials — Determination of colour stability
ISO 7500-1, Metallic materials — Calibration and verification of static uniaxial testing machines — Part 1:
Tension/compression testing machines — Calibration and verification of the force-measuring system
ISO 8601-1, Date and time — Representations for information interchange — Part 1: Basic rules
ISO 18739, Dentistry — Vocabulary of process chain for CAD/CAM systems
ISO 22674, Dentistry — Metallic materials for fixed and removable restorations and appliances
ISO/ASTM 52900:2021, Additive manufacturing — General principles — Fundamentals and vocabulary
ISO 5139, Dentistry — Polymer-based composite machinable blanks
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 https:// www .electropedia .org/
ISO/DIS 10477:2025(en)
3.1
polymer-based crown and veneering material
composition of powders, liquids, pastes (after full polymerization) or polymerized discs or blocks (already
polymerized by the manufacturer) that may contain monomers, inorganic and/or polymeric fillers 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.
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 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.
3.6
milling
synonym subtractive manufacturing: process of machining, grinding, or reducing a larger bulk object to
create a smaller detailed three-dimensional object using CAD/CAM methods
Note 1 to entry: The term milling is used in this document as it is a common term in dental technology and clinical
dentistry for the processing of these materials
3.7
printing
synonym additive manufacturing: process in which a liquid photopolymer in a vat (3.8) is selectively cured
by light-activated polymerization. The liquid photopolymer may contain fillers.
Note 1 to entry: The term printing is used in this document as it is a common term in dental technology and clinical
dentistry for the processing of these materials
3.8
vat
small tub, part of the polymerization device that contains the liquid photopolymer.
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);
ISO/DIS 10477:2025(en)
— 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
and are not intended for additive manufacturing (printing);
— Class 3: polymer-based crown and veneering materials that are intended for additive manufacturing
(printing);
— Type 3: polymer-based crown and veneering materials whose setting is affected by mixing initiator(s)
and activator(s) and also by the application of energy from an external source (“dual-cure” materials);
— Type 4: polymer-based crown and veneering materials that are intended for subtractive manufacturing
(milling).
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.
Table 1 — Test protocol
Subclause Property Type 1 Type 2 Type 3 Type 4
Class 1 Class 2 Class 3
a b
5.2 Depth of cure — — + — — —
a a a a
5.3 Surface finish + + + + + +
a a a a
5.4 Flexural strength + + + + + +
c c
5.5 Bond strength to the + + + - + -
framework
a a a a
5.6 to 5.9 Water sorption, + + + + + +
solubility, shade
consistency, colour
stability
Key
+ carry out test;
— do not test;
a
If the material is opaque resin, do not test;
b
Not required because fixed part of the printing process;
c
Not required as these materials are not intended for veneering.
5.2 Depth of cure
5.2.1 General
Testing shall be carried out in accordance with 7.3.
ISO/DIS 10477:2025(en)
5.2.2 Depth of cure (only type 2 class 2 materials)
For type 2 class 2 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 and type 4 materials, no requirement is specified. This requirement is
not applicable to opaque resins.
For type 2 class 3 materials no requirement is specified as the curing process is inherently defined in the
printing process.
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
Flexural strength shall be at least 50 MPa for type 1 and type 2 classes 1 and 2 and type 3, and at least 80 MPa
for type 2 class 3 and type 4 materials (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
Flexural strength ≥50 MPa for type 1 and type 2 classes 1 and 2
5.4 and type 3
≥ 80 MPa for type 2 class 3 and type 4
5.5.1 Bond strength ≥5 MPa
5.5.2 ≥80 % of the value claimed but ≥5 MPa
5.6 Water sorption ≤40 µg/mm
5.7 Solubility ≤7,5 µg/mm
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 with a minimum of 5 MPa.
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.
ISO/DIS 10477:2025(en)
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.
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 material to carry out the specified tests, plus an allowance
for any necessary repetition of tests.
NOTE For type 1, type 2 classes 1 and 2, and type 3 materials, approximately 20 ml of material may be needed.
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 but from
another batch.
NOTE For type 1, type 2 classes 1 and 2, and type 3 materials, approximately 1 ml of material will be needed.
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. They should be selected in
consideration of its colouring components, if different colouring components are used.
NOTE For type 1, type 2 classes 1 and 2, and type 3 materials, approximately 1 ml of material will be needed.
7 Measurement and test methods
7.1 General
7.1.1 Ambient test conditions
Tests shall be carried out at room conditions (23 ± 2) °C and (50 ± 20) % relative humidity.
ISO/DIS 10477:2025(en)
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 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. 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.
Printing (type 2, class 3 materials))
Print and process the polymer-based crown and veneering material in accordance with the instruction for use.
Milling (type 4 materials)
Mill in accordance with the instruction for use or saw the polymer-based crown and veneering material
or the polymer-based crown and veneering material in a similar way, taking care to avoid excess heat
generation
7.2 Visual inspection
Use visual inspection to determine conformity to Clause 8. The colour comparison in 7.8 shall be performed
in accordance with ISO 7491.
7.3 Depth of cure (only for type 2, class 2 if not opaque resin)
7.3.1 Apparatus
7.3.1.1 Split rings such as shown in Figure 1, (15 ± 1) mm in diameter and (1,0 ± 0,1) mm in height.
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.
7.3.1.4 Hardness testing instrument, for HV 0,5.
7.3.1.5 Oven, set at (37 ± 1) °C.
7.3.2 Materials
7.3.2.1 White filter paper.
7.3.2.2 Film, colourless, transparent, (50 ± 30) μm thick.
ISO/DIS 10477:2025(en)
7.3.2.3 Polishing compound, precipitated calcium carbonate (CaCO ).
7.3.2.4 Muslin wheel, unstitched, 18-to 36-ply, having a diameter of 70 mm to 95 mm.
7.3.3 Procedure
7.3.3.1 Specimen preparation
Cover one plate (7.3.1.2) with a piece of white filter paper (7.3.2.1) followed by the film (7.3.2.2), and position
the split ring (7.3.1.1) upon it. Prepare the polymer-based crown and veneering material according to the
instruction for use, and place it into the split ring to a slight excess. Cover the polymer-based crown and
veneering material and the split ring with a second piece of film and the second plate (7.3.1.2), and extrude
the excess material. Remove the upper plate and irradiate the test specimen in the split ring through the
film, in accordance with the instruction for use. Remove the test specimen from the split ring.
Prepare three specimens and store them in water at (37 ± 1) °C for (24 ± 2) h. Carry out the hardness test on
the upper and lower surfaces of the specimens three times in accordance with ISO 6507-1.
7.3.4 Expression of results
Express the hardness of each surface as the mean of the three values obtained for it.
All three specimens shall meet the requirement of 5.2. Otherwise the polymer-based crown and veneering
material does not comply with the requirement of 5.2.
7.4 Surface finish
7.4.1 Apparatus (for type 2 class 3 and type 4 materials)
7.4.1.1 vat photopolymerization device (for type 2 class 3), as recommended in the instructions for use.
7.4.1.2 Cleaning device (for type 2 class 3), for removing unreacted monomer as recommended in the
instructions for use.
7.4.1.3 Post curing device (for type 2 class 3), as recommended in the instructions for use.
7.4.1.4 Milling machine (for type 4), as recommended in the instructions for use.
7.4.1.5 Abrasive paper, at P220 or P320 according to ISO 6344-2.
7.4.1.6 Abrasive paper, at least P1000 according to ISO 6344-2.
7.4.2 Specimen preparation
For type 1, type 2 classes 1 and 2, and type 3 materials prepare a specimen according to 7.3.3. Polish the
test specimen prepared in accordance with the instruction for use. If no specific procedure is given, polish
according to the instructions provided under 7.4.3.
For type 2 class 3 materials Manufacture the specimen in the required dimension (round specimen,
diameter (15 ± 1) mm, heights (1,0 ± 0,1) mm or square shaped specimen, (13 ± 1) mm, heights (1,0 ± 0,1) mm.
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper
(7.4.1.4).
After removing any flash, polish the surface, using P1000/P2000 of abrasive paper (7.4.1.5)
ISO/DIS 10477:2025(en)
For type 4 materials mill or saw the specimen in the required dimension (round specimen, diameter
(15 ± 1) mm, heights (1,0 ± 0,1) mm or square shaped specimen, (13 ± 1) mm, heights (1,0 ± 0,1) mm.
Remove the supports and carefully remove any flash by gently abrading with P220 or P320 of abrasive paper
(7.4.1.4).
After removing any flash, polish the surface, using P1000/P2000 of abrasive paper (7.4.1.5)
7.4.3 Surface polishing
Grind (wet) the specimen on both sides and polish according to the instruction for use. If no specific
procedure is given polish for not longer than 1 min with a muslin wheel (7.3.2.4) at a circumferential speed of
(650 ± 350) m/min and with polishing compound (7.3.2.3). Keep at least 10 mm between the outer diameter
of the wheel and the stitching or other reinforcement.
Thoroughly clean the specimen by rinsing with water, blot dry, and visually inspect the surface. If the surface
of the specimen is glossy when visually inspected. the polymer-based veneering material complies with the
requirements of paragraph 5.3.
NOTE A wheel with a diameter of 70 mm rotating at 1 500 r/min has a circumferential speed of 330 m/min and a
100 mm diameter wheel rotating at 3 500 r/min has a circumferential speed of 1 100 m/min.
ISO/DIS 10477:2025(en)
Dimensions in millimetres
Key
1 glass or metal plates
2 split ring
3 retaining plate or former
Figure 1 — Mould for the preparation of test specimens for depth of cure, surface finish, water
sorption, solubility, shade consistency and colour stability
7.5 Flexural strength
7.5.1 Apparatus
7.5.1.1 Split stainless steel mould (for type 1, type 2 classes 1 and 2, and type 3 materials), coated with
a separating medium (e.g. 3 % solution of polyvinylstearyl ether wax in hexane), as shown in Figure 2, in an
appropriate mounting device.
7.5.1.2 Two glass or metal plates (for type 1, type 2 classes 1 and 2, and type 3 materials), of
approximately 30 mm × 30 mm × 2 mm.
ISO/DIS 10477:2025(en)
7.5.1.3 Small screw clamp (for type 1, type 2 classes 1 and 2, and type 3 materials).
7.5.1.4 Polymerization apparatus (for type 2 classes 1 and 2, and type 3 materials), as recommended in
the instruction for use.
7.5.1.5 vat photopolymerization device (for type 2 class 3), as recommended in the instructions for use.
7.5.1.6 Cleaning device (for type 2 class 3), for removing unreacted monomer as recommended in the
instructions for use.
7.5.1.7 Post curing device (for type 2 class 3), as recommended in the instructions for use.
7.5.1.8 Milling machine (for type 4), as recommended in the instructions for use.
7.5.1.9 Saw (optional) suitable for cutting type 4 material
7.5.1.10 Oven, set at (37 ± 1) °C.
7.5.1.11 Flexural strength test apparatus, calibrated according to ISO 7500-1, to provide a constant
cross-head speed of (1,0 ± 0,3) mm/min. The apparatus consists of two rods (2 mm in diameter), mounted
parallel with 12 mm (according to ISO 5139) between centres, and a third rod (2 mm in diameter) centred
between, and parallel to the other two, so that the three rods in combination can be used to give a three-
point loading to the specimen. Other instruments with a constant loading rate of (50 ± 16) N/min may also
be used.
7.5.1.12 Micrometer, with an accuracy of 0,01 mm.
7.5.1.13 Timer, accurate to ±1 s.
7.5.2 Materials
7.5.2.1 White filter paper, as in 7.3.2.1.
7.5.2.2 Film, as in 7.3.2.2.
7.5.2.3 Abrasive paper, P 2000 according to ISO 6344-2.
7.5.2.4 Metal or glass plates, 1 quartz plate for UV photo-initiated material, no less than
30 mm × 10 mm × 2 mm.
7.5.2.5 Water, conforming to ISO 3696, Grade 2.
ISO/DIS 10477:2025(en)
Dimensions in millimetres
Figure 2 — Split mould for test specimens for the flexural test for type 1, type 2 classes 1 and 2, and
type 3 materials
7.5.3 Preparation of test specimens
Prepare five specimens according to 7.5.3.1 to 7.5.3.4. After preparation store the specimen in water (7.5.2.5)
at (37 ± 1) °C (7.5.1.10) until the start of testing (7.5.4). Specimens shall be plane-parallel for flexural testing.
7.5.3.1 Type 1 and type 2 class 1 materials
Cover one of the metal or glass plates (7.5.1.2) with the film (7.5.2.2), and position the mould (7.5.1.1) upon
it. Prepare the polymer-based crown and veneering material in accordance with the instruction for use and
immediately place it in the mould to a slight excess. Place a second piece of film onto the polymer-based
crown and veneering material in the mould and cover this with the second metal or glass plate. Apply
pressure to displace excess material by means of the clamp (7.5.1.3).
Polymerize the polymer-based crown and veneering material in accordance with the instruction for use.
Fifteen minutes after polymerization, remove the specimen and carefully remove any flash by gently
abrading with abrasive paper (7.5.2.3), avoiding touching any other surface.
7.5.3.2 Type 2 class 2 and type 3 materials
For light (385 nm to 515 nm) photo-polymerization initiator materials cover with a glass plate as top plate;
for UV (below 385 nm) photo-polymerization initiator materials cover with a quartz plate as top plate.
Cover the bottom plate with the white filter paper (7.5.2.1), followed by the film (7.5.2.2), and position the
mould (7.5.1.1) upon it. Prepare the polymer-based crown and veneering material in accordance with the
instruction for use and fill the mould with the polymer-based crown and veneering material, as described
in 7.5.3.1. Place a second piece of film on the polymer-based crown and veneering material in the mould.
For light photo-polymerization initiator materials cover this with a glass plate; for photo-polymerization
initiator materials
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