ISO 10477-2020 PDF

Full title and description

ISO 10477:2020 — Dentistry — Polymer-based crown and veneering materials. This International Standard classifies polymer-based materials used for laboratory-fabricated permanent crowns and veneers, and specifies performance, physical and chemical requirements together with the test methods used to verify conformity.

Abstract

ISO 10477:2020 sets out classification, required properties and standardized test methods for polymer-based crown and veneering materials intended for permanent laboratory-fabricated restorations. It also covers materials for which the manufacturer claims adhesion to a substructure without macro-mechanical retention. The standard defines sampling, specimen preparation and specific test procedures to determine conformity.

General information

• Status: Published (International Standard)
• Publication date: 26 October 2020 (ISO 10477:2020, Edition 4, 2020-10)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.060.10 — Dental materials
• Edition / version: Edition 4 (2020)
• Number of pages: 21 (ISO edition document)

Basic bibliographic and lifecycle details as published by ISO (edition, ICS classification and page count shown by the ISO catalogue entry).

Scope

This standard applies to polymer-based crown and veneering materials intended for laboratory fabrication of permanent veneers or crowns. It also applies when the manufacturer claims adhesion to a substructure without macro-mechanical retention (for example, without beads or wires). The standard covers classification, required properties, sampling and the test methods needed to assess conformity.

Key topics and requirements

• Classification of polymer-based crown and veneering materials by type/class and intended use (including distinctions for opaque resins and light-cured systems).
• Depth of cure requirement for specific material classes (bottom-surface hardness not less than a specified proportion of top-surface hardness for certain types).
• Surface finish: polished test specimens shall exhibit a glossy surface.
• Flexural strength: a minimum flexural strength requirement (commonly specified as ≥ 50 MPa for applicable classes).
• Bond strength: where a special bonding system is claimed (without macro-mechanical retention), bond strength requirements apply (minimum ≈ 5 MPa and, if a higher value is claimed, verification to a percentage of the claimed value is required).
• Water sorption and solubility limits (examples of maximum values: water sorption ≤ 40 µg/mm³; solubility ≤ 7.5 µg/mm³ for cured materials).
• Shade consistency and colour stability testing procedures (including sampling across batches and use of standardized colour-measurement methods).
• Specification of specimen preparation, test conditions (temperature, humidity, water quality) and references to the relevant test clauses within the standard.
• Guidance to manufacturers on marking, instructions for use and considerations for biocompatibility information.

Numerical requirements and test items (flexural strength, bond strength, water sorption, solubility, depth-of-cure and colour tests) are specified in the standard's requirement tables and test-method clauses.

Typical use and users

Primary users are dental materials manufacturers, dental laboratories, regulatory bodies and conformity assessment entities. The standard is used by product developers to design and validate polymer-based crown/veneering materials, by quality assurance teams to prepare batch testing protocols, and by regulatory reviewers assessing compliance for market authorization or procurement. Dental laboratories and clinicians may reference the standard to understand material classification and performance claims.

Related standards

ISO 10477 is part of the dental materials family of standards (ICS 11.060.10) and is coordinated by ISO/TC 106/SC 2. A revision in the form of ISO/FDIS 10477 has been developed to replace the 2020 edition (FDIS stage noted by ISO). Other related standards referenced for test methods or complementary requirements include standards for colour measurement and other dental-material test standards invoked within ISO 10477.

Keywords

dentistry; dental materials; polymer-based crowns; veneering materials; flexural strength; water sorption; solubility; bond strength; depth of cure; shade consistency; colour stability; ISO 10477; testing; specimen preparation.

FAQ

Q: What is this standard?

A: ISO 10477:2020 is an International Standard that defines classification, requirements and test methods for polymer-based crown and veneering materials used for laboratory-fabricated permanent dental restorations.

Q: What does it cover?

A: It covers material classification, physical and chemical performance requirements (such as depth of cure, surface finish and flexural strength), bond-strength verification where special bonding systems are claimed, water sorption and solubility limits, shade consistency and colour-stability testing, specimen preparation and test conditions, and guidance on marking and instructions for use.

Q: Who typically uses it?

A: Manufacturers of polymer-based crown and veneering materials, dental laboratories, test laboratories performing conformity testing, regulatory reviewers and standards committees use ISO 10477 for product development, quality control and regulatory compliance.

Q: Is it current or superseded?

A: ISO 10477:2020 is the published edition (Edition 4). ISO has progressed a revision in the form of ISO/FDIS 10477 (Final Draft International Standard) which is intended to replace the 2020 edition as part of the standard review/revision process. Users should check the ISO catalogue or national standards bodies for the latest publication status when purchasing or applying the standard.

Q: Is it part of a series?

A: It belongs to the family of standards covering dental materials and is produced under ISO/TC 106 (Dentistry), subcommittee SC 2 (Dental restorative materials). Related ISO and EN standards address specific test methods and other dental-material categories referenced by ISO 10477.

Q: What are the key keywords?

A: Polymer-based crown, veneering material, dentistry, flexural strength, water sorption, solubility, bond strength, depth of cure, shade consistency, colour stability, specimen preparation.