ISO TS 4640-2023 PDF

Full title and description

ISO/TS 4640:2023 — Dentistry — Test methods for tensile bond strength to tooth structure. This Technical Specification gives guidance for substrate selection, storage and handling and defines essential characteristics of tensile bond strength test methods used to assess the adhesive bond between restorative dental materials and tooth structure (enamel and dentine).

Abstract

This Technical Specification focuses on tensile bond strength test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure. It provides general guidance and essential method characteristics; specific tensile test procedures are given informatively in Annex A. The document does not set requirements for adhesive material components or their performance.

General information

• Status: Published.
• Publication date: 4 May 2023 (Edition 1, 2023-05).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.060.10 (Dental materials).
• Edition / version: Edition 1 (Technical Specification, 2023).
• Number of pages: 16 pages (ISO publication).

These bibliographic and lifecycle details are recorded on the ISO publication entry for ISO/TS 4640:2023.

Scope

ISO/TS 4640:2023 is limited to guidance and essential characteristics for tensile bond strength test methods used to evaluate the adhesive bond between restorative dental materials and tooth structure (enamel and dentine). It addresses substrate selection, specimen storage and handling, and key test-method characteristics; it does not include requirements for adhesive material composition or clinical performance specifications. Informative Annex A provides example tensile test procedures.

Key topics and requirements

• Guidance on substrate (tooth) selection, storage and handling to ensure repeatable, representative test conditions.
• Essential characteristics and performance attributes that tensile bond strength methods should demonstrate (e.g., specimen geometry, alignment, loading rate, failure-mode reporting).
• Standardized reporting items to allow comparability of tensile bond strength results between laboratories and manufacturers.
• Informative examples of tensile bond strength test procedures provided in Annex A.
• Explicit exclusion of requirements for adhesive material components and their clinical performance — the document is restricted to test methods and method quality.

Typical use and users

Used by dental materials researchers, dental product manufacturers, quality-control and materials testing laboratories, standards committees, and regulatory bodies to design, perform and interpret tensile bond-strength testing of restorative adhesives and bonded restorations. Dental schools and clinical-research groups may use the TS when comparing adhesive systems or validating laboratory test protocols.

Related standards

ISO/TS 4640:2023 was developed by ISO/TC 106/SC 1 and replaces the earlier TS covering adhesion testing. It cancels and replaces ISO/TS 11405:2015 (Testing of adhesion to tooth structure), which was withdrawn as part of the revision process that retained only tensile bond-strength methods. A committee draft (ISO/CD TS 4640) is also recorded in the ISO lifecycle as part of ongoing development activities.

Keywords

dentistry; dental materials; tensile bond strength; adhesion testing; enamel; dentine; restorative materials; test methods; specimen preparation; bond-strength testing.

FAQ

Q: What is this standard?

A: ISO/TS 4640:2023 is an ISO Technical Specification that provides guidance and essential characteristics for tensile bond strength test methods used to evaluate the adhesive bond between restorative dental materials and tooth structure (enamel and dentine).

Q: What does it cover?

A: It covers substrate selection, specimen storage and handling, essential test-method characteristics, reporting items for comparability, and includes example tensile test procedures in Annex A. It does not set requirements for adhesive material composition or clinical performance.

Q: Who typically uses it?

A: Dental materials researchers, manufacturers of restorative adhesives and restorative materials, testing and quality-control laboratories, standards developers, regulatory reviewers, and academic investigators performing laboratory bond-strength studies.

Q: Is it current or superseded?

A: It is current (published 4 May 2023). It cancels and replaces the previous Technical Specification ISO/TS 11405:2015, which was withdrawn as part of the revision process.

Q: Is it part of a series?

A: The document was prepared by ISO/TC 106/SC 1 (Filling and restorative materials) and sits within ISO's dental materials work. It follows the committee’s restructuring of adhesion-testing guidance and is linked in lifecycle records to subsequent committee drafts (ISO/CD TS 4640) as the document family evolves.

Q: What are the key keywords?

A: Tensile bond strength, adhesion testing, dental materials, enamel, dentine, restorative materials, specimen preparation, test methods, bond-strength reporting.