ISO 10993-1:2025 - Biological Evaluation of Medical Devices

What are the key changes in ISO 10993-1:2025?

The ISO 10993 latest version introduces several updates to reflect current scientific knowledge and regulatory expectations:

• Improved categorization of devices by contact type and duration.
• Alignment of ISO 10993-1 with the risk-based ISO 14971 standard.
• The role of scientific argumentation in equivalence studies.
• Alignment with EU MDR and REACH for substances of concern, and consideration of the entire life cycle.
• The role of chemical characterisation in biological assessment.
• Study of data gaps in existing information for the medical device.

These changes reinforce a risk-based approach and support harmonization across global markets.

ISO 10993-1:2025 requirements

The ISO 10993-1:2025 standard requires manufacturers to:

• Define the device’s clinical context and patient exposure.
• Categorize the device based on contact type (e.g., skin, mucosal, blood) and duration (transient, short-term, long-term).
• Identify relevant biological endpoints (e.g., cytotoxicity, sensitization, genotoxicity).
• Characterisation of the physical and chemical properties of the medical device.
• Select appropriate tests from the ISO 10993 series.
• Justify material choices and assess any changes in composition or supplier.

These requirements ensure a tailored and scientifically sound biological evaluation.

ISO 10993-1:2025 objectives

The objectives of ISO 10993-1:2025 are to:

• Minimize biological risks associated with medical devices.
• Provide a structured and consistent evaluation framework.
• Support regulatory submissions under MDR and FDA.
• Enable early identification of biocompatibility issues during design and development.

By following this standard, manufacturers can ensure device safety and accelerate market access.

What services do we offer for ISO 10993-1:2025?

Applus+ Laboratories provides comprehensive services for the biological evaluation of medical devices with ISO 10993-1:2025:

• Chemical characterization and E&L testing in compliance with ISO 10993-18 and ISO 10993-12.
• Morphological and topographical analyses according to ISO 10993-19.
• Degradation product respectively related to polymers, ceramics & metals and alloys devices (10993-13; 10993-14; 10993-15). 
• Expert consulting on material selection, change control, and post-market monitoring.

Our ISO 17025-accredited labs and ISO 13485-certified quality system ensure reliable, reproducible, and regulatory-compliant results.