National foreword

This British Standard is the UK implementation of EN ISO 10477:2026. It is identical to ISO 10477:2026. It supersedes BS EN ISO 10477:2020, which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/106, Dentistry.

A list of organizations represented on this committee can be obtained on request to its committee manager.

Contractual and legal considerations

This publication has been prepared in good faith, however no representation, warranty, assurance or undertaking (express or implied) is or will be made, and no responsibility or liability is or will be accepted by BSI in relation to the adequacy, accuracy, completeness or reasonableness of this publication. All and any such responsibility and liability is expressly disclaimed to the full extent permitted by the law.

This publication is provided as is, and is to be used at the recipient’s own risk.

The recipient is advised to consider seeking professional guidance with respect to its use of this publication.

This publication is not intended to constitute a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30 September 2026.

This European Standard was approved by CEN on 18 July 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and United Kingdom.

European foreword

This document (EN ISO 10477:2026) has been prepared by Technical Committee ISO/TC 106 "Dentistry" in collaboration with Technical Committee CEN/TC 55 “Dentistry” the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2027, and conflicting national standards shall be withdrawn at the latest by March 2027.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 10477:2020.

Any feedback and questions on this document should be directed to the users’ national standards body/national committee. A complete listing of these bodies can be found on the CEN website.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the United Kingdom.

Endorsement notice

The text of ISO 10477:2026 has been approved by CEN as EN ISO 10477:2026 without any modification.

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).

ISO draws attention to the possibility that the implementation of this document may involve the use of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights in respect thereof. As of the date of publication of this document, ISO [had/had not] received notice of (a) patent(s) which may be required to implement this document. However, implementers are cautioned that this may not represent the latest information, which may be obtained from the patent database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.

Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 106, Dentistry, Subcommittee SC 2, Prosthodontic materials, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 55, Dentistry, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

This fifth edition cancels and replaces the fourth edition (ISO 10477:2020), which has been technically revised.

The main changes are as follows:

materials for additive manufacturing have been added to Clause 4 as type 2 class 3;
materials for subtractive manufacturing have been added to Clause 4 as type 4;
editorial updates have been made.

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.

Introduction

Specific qualitative and quantitative test methods for demonstrating freedom from unacceptable biological hazards are not included in this document, but, for the assessment of possible biological hazards, reference should be made to ISO 10993-1 [1] and ISO 7405 [2].

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

3 Terms and definitions

4 Classification

5 Requirements

5.1 General

5.2 Depth of cure

5.3 Surface finish

5.4 Flexural strength

5.5 Bond strength

5.6 Water sorption

5.7 Solubility

5.8 Shade consistency

5.9 Colour stability

6 Sampling

6.1 For all tests

6.2 For test of shade consistency

6.3 For test of colour stability

7 Measurement and test methods

7.1 General

7.2 Visual inspection

7.3 Depth of cure (only for type 2, class 2 if not opaque resin)

7.4 Surface finish

7.5 Flexural strength

7.6 Bond strength (only type 1, type 2 classes 1 and 2 and type 3 materials)

7.7 Water sorption and solubility

7.8 Shade consistency and colour stability

8 Packaging and labelling

8.1 Packaging

8.2 Labelling and instructions for use

Bibliography