ISO 7405:2018

Overview

ISO 7405:2018 - Dentistry: Evaluation of biocompatibility of medical devices used in dentistry specifies test methods and a biological evaluation framework for dental medical devices that come into direct or indirect contact with patients. It covers device categorization, material characterization as a first step, selection of biological tests, and specific dental test methods (including tests for integrated pharmacological agents). Devices that do not contact the patient are excluded.

Key topics and technical requirements

• Material characterization first: The standard requires physical and chemical characterization of materials before conducting biological tests to inform test selection and reduce unnecessary animal use.
• Device categorization:
  • By nature of contact: non‑contact, surface‑contacting, external‑communicating, and implants.
  • By duration of contact: limited exposure, prolonged exposure, and permanent contact.
• Biological evaluation process:
  • Risk‑based selection of tests and overall assessment in line with the ISO 10993 series.
  • Emphasis on minimizing animal testing and combining compatible tests when appropriate.
• Specific dental test methods:
  • In vitro assays such as agar diffusion and filter diffusion cytotoxicity tests.
  • Dental‑specific in vivo/usage tests: pulp and dentine usage test, pulp capping test, endodontic usage test.
  • Informative annexes include dentine barrier cytotoxicity and endosseous dental implant usage tests.
• Sample preparation guidance: General recommendations plus specific instructions for light‑curing and chemically setting dental materials.
• Reporting and assessment: Each test includes defined controls, assessment parameters and test report requirements.

Practical applications and who uses ISO 7405

• Manufacturers of dental restorative materials, adhesives, endodontic materials, implants and dental devices use ISO 7405 to design preclinical biocompatibility programs and prepare regulatory submissions.
• Regulatory bodies and notified bodies rely on the standard to evaluate biological safety evidence for dental devices.
• Test laboratories adopt the standard’s sample preparation, test selection and reporting practices for dental biocompatibility testing.
• R&D and quality teams use the guidance to integrate material characterization, reduce animal testing and align with international best practices.

Related standards

• ISO 10993 series - Biological evaluation of medical devices (referenced for general test selection and methods).
• ISO 10993‑18 - Chemical characterization of materials (linked by corrected references).
• ISO/TS 22911 - Included as an informative annex in the 2018 edition; relevant for some dental testing contexts.

ISO 7405 is essential for ensuring safe, compliant dental devices through targeted biocompatibility testing and risk‑based evaluation.