ISO 7405:2025
2025-06
ISO 7405:2025
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.
Benefits
- Protects patients by ensuring dental devices are biologically safe
- Provides internationally recognised test methods tailored to dentistry
- Encourages ethical testing through alternative methods
- Aligns dental testing practices with ISO 10993 for broader compatibility
- Supports innovation with clear safety validation frameworks
FAQ
Manufacturers and testing laboratories that develop or evaluate dental medical devices, including those with integrated pharmacological components.
The latest edition includes updated normative references, new definitions (like “dentine barrier”), harmonized test assessment criteria with ISO 10993-5, and two new annexes: one for an ARE reporter assay cytotoxicity test and another outlining a margin of safety (MoS) approach for dental medical devices.
No, it is intended to be used alongside the ISO 10993 series, which provides general principles for biocompatibility testing across all types of medical devices.
General information
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Status: PublishedPublication date: 2025-06Stage: International Standard confirmed [90.93]
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Edition: 4Number of pages: 60
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Technical Committee :ISO/TC 106
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Life cycle
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Previously
WithdrawnISO 7405:2018
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Now
