What is ISO 10993-3?

ISO 10993-3 provides strategies for evaluating biological risks related to genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity in medical devices.

It is used when these biological effects have been identified as relevant to the safety evaluation of a medical device. Rather than treating biological safety as a predefined testing exercise, the standard emphasizes risk-based evaluation, taking into account factors such as intended human use, exposure and interactions with biological systems.

The standard also supports the use of chemical characterization and toxicological risk assessment to determine whether testing is necessary and how potential biological hazards should be addressed. Where testing is appropriate, it provides evaluation strategies and relevant test methods.

This edition represents a significant revision of ISO 10993-3, with greater emphasis on evaluation rather than testing alone, and incorporates genotoxicity test method guidance previously contained in ISO/TR 10993-33.

Why is ISO 10993-3 important?

Some potential biological effects associated with medical devices, including cancer, genetic damage and reproductive or developmental harm, can be serious and irreversible. ISO 10993-3 helps manufacturers evaluate these risks systematically as part of the wider biological safety and risk management process.

By combining information on device use and exposure with chemical characterization, toxicological risk assessment and, where necessary, biological testing, the standard supports a more scientifically justified approach to safety evaluation. This can help organizations avoid unnecessary testing while ensuring that relevant biological hazards are appropriately investigated.

It also provides a framework for integrating these evaluations with other parts of the ISO 10993 series and medical device risk management under ISO 14971.

Benefits

• Supports systematic evaluation of genotoxicity, carcinogenicity, reproductive toxicity and developmental toxicity risks
• Enables a risk-based approach that considers intended use, exposure and biological interactions
• Helps determine when chemical characterization and toxicological risk assessment can inform or reduce the need for biological testing
• Provides strategies for selecting and interpreting appropriate evaluation and test methods
• Supports integration with the wider ISO 10993 biological evaluation framework and ISO 14971 risk management
• Helps build a scientifically justified biological safety assessment for medical devices

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