ISO 7405-2018 PDF

Full title and description

ISO 7405:2018 — Dentistry — Evaluation of biocompatibility of medical devices used in dentistry. This international standard specifies test methods and evaluation approaches for assessing the biological effects of dental medical devices and includes guidance for devices that incorporate pharmacological agents as an integral part of the device. It is intended to support safety assessment of materials and devices that come into direct or indirect contact with the patient.

Abstract

ISO 7405:2018 defines test methods and considerations for the biological evaluation of dental medical devices. It covers selection of tests, specimen preparation and extraction, and interpretation of results for endpoints such as cytotoxicity, irritation, sensitization and systemic/local toxicity. The document excludes materials and devices that do not come into direct or indirect contact with the patient. The 2018 edition was later withdrawn and superseded by a 2025 edition.

General information

• Status: Withdrawn (superseded).
• Publication date: October 2018 (corrected version issued November 2018).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.060.10 (Dental materials); 11.100.99 (Other standards related to laboratory medicine).
• Edition / version: Edition 3 (2018).
• Number of pages: 43.

Scope

This standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry, including devices containing pharmacological agents that are integral to the device. It applies to devices and materials that contact oral tissues either directly or indirectly. It does not cover devices or materials that have no direct or indirect contact with the patient. The standard is intended to be used as part of a biological evaluation program together with general biocompatibility principles (for example, those in the ISO 10993 series).

Key topics and requirements

• Selection of appropriate biological endpoints for dental devices (cytotoxicity, irritation, sensitization, systemic toxicity, local effects, implantation where applicable).
• Specimen preparation and extraction procedures tailored to dental materials and device geometries.
• Recommended in vitro and in vivo test methods and considerations specific to the oral environment.
• Guidance on interpretation of test results and limits of test applicability for dental use.
• Considerations for devices incorporating pharmacological agents and combined-device assessments.
• Emphasis on ethical testing practices and use of validated alternatives to animal testing where appropriate.

Typical use and users

Manufacturers of dental medical devices and materials use ISO 7405:2018 to design and document biological safety testing strategies. Testing and certification laboratories apply the methods when evaluating dental products. Regulatory bodies, conformity assessment organizations, dental materials researchers and product development teams also rely on the standard to interpret biological test data and to harmonize dental-specific biocompatibility approaches with wider medical-device practice.

Related standards

ISO 7405:2018 is intended to be used alongside the ISO 10993 series (biological evaluation of medical devices), particularly ISO 10993-1 (evaluation and testing within a risk management process) and parts addressing cytotoxicity, irritation, sensitization and systemic toxicity. It replaces earlier ISO 7405 editions and is related to ISO/TS 22911 on preclinical evaluations. National and regional adoptions (EN ISO versions) may also exist.

Keywords

biocompatibility, dentistry, dental devices, cytotoxicity, irritation, sensitization, systemic toxicity, implantation, extraction procedures, in vitro testing, animal testing alternatives, ISO 10993.

FAQ

Q: What is this standard?

A: ISO 7405:2018 is an international standard that provides test methods and guidance for evaluating the biological safety (biocompatibility) of medical devices used in dentistry.

Q: What does it cover?

A: It covers selection of biological endpoints, specimen preparation and extraction, recommended in vitro and in vivo test methods (cytotoxicity, irritation, sensitization, systemic and local toxicity, implantation where relevant), and interpretation guidance for devices that contact the oral environment. It excludes devices that do not contact the patient.

Q: Who typically uses it?

A: Device manufacturers, testing laboratories, regulatory and conformity-assessment bodies, dental researchers and product development teams use the standard when planning and assessing biological safety testing for dental products.

Q: Is it current or superseded?

A: The 2018 edition has been withdrawn and has been superseded by a later edition published in 2025. Users should consult the 2025 edition for the current, authoritative requirements.

Q: Is it part of a series?

A: Yes. ISO 7405 is intended to be used in conjunction with the ISO 10993 series (biological evaluation of medical devices) and other dentistry-related standards and technical specifications maintained by ISO/TC 106 (Dentistry).

Q: What are the key keywords?

A: Biocompatibility, dentistry, dental devices, cytotoxicity, irritation, sensitization, systemic toxicity, implantation, ISO 10993.