ISO 7405:2025

Dentistry — Evaluation of biocompatibility of medical devices used in dentistry Published (Edition 4, 2025) This publication was last reviewed and confirmed in 2025. Therefore this version remains current.

What is ISO 7405?

ISO 7405 provides a set of biological test methods to evaluate the biocompatibility of medical devices used in dentistry. These tests help determine whether a device or material that comes into direct or indirect contact with a patient’s body is safe for use. ISO 7405 is designed to be used in conjunction with the ISO 10993 series, which provides more general guidance on biological evaluation of medical devices.

Why is ISO 7405 important?

Ensuring that dental materials and devices are biologically safe is essential for protecting patients and maintaining public trust in dental care. ISO 7405 addresses the unique needs of dentistry with targeted test methods developed from significant practical experience. The standard also reflects a strong commitment to ethical testing, promoting the reduction and refinement of animal use through validated in vitro alternatives whenever possible.