Foreword

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This document was prepared by Technical Committee ISO/TC 106, Dentistry, 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 fourth edition cancels and replaces ISO 7405:2018 which has been technically revised.

The main changes compared to the previous edition are as follows:

— update on normative references (e.g. replacement of ISO 6344-1 with ISO 6344-3);
— clarification on text of definitions and addition of definition for dentine barrier (3.8);
— for the agar diffusion test (6.2) the criteria for assessment of decolorization zone (Table 1) and qualitative morphological/lysis index (Table 2) were harmonized with ISO 10993-5;
— addition of Annex D with an antioxidant responsive element (ARE) reporter assay cytotoxicity test.
— addition of Annex E “Margin of safety (MoS) for medical devices used in dentistry”.

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.

ISO 7405:2025

Dentistry. Evaluation of biocompatibility of medical devices used in dentistry

Current

Published:

20 Jun 2025