ISO 10993-17: Guidelines for Medical Device Manufacturers

The ISO 10993-17 standard, after over two decades of development, has recently undergone a comprehensive revision, signaling a significant update to the series of standards related to biocompatibility. This standard focuses on the procedures of Toxicological Risk Assessment (TRA), which are crucial for ensuring the safety of patients using medical devices.

Background of Toxicological Risk Assessment (TRA)

Toxicological Risk Assessment plays a crucial role in the assessment of biocompatibility, aiming to identify and evaluate potential health risks including:

- Substances released from device materials

- Contaminants introduced during manufacturing processes

- Degradation products

These risks are assessed by determining thresholds and estimating exposure levels.

Regulatory Requirements

The MDR emphasizes minimizing risks posed by substances and residues to patients and users during the design and manufacture of medical devices, with particular attention to exposed tissues, as well as the duration and frequency of exposure.

Key Changes and Implementation

- Compliance Timing: Understand when your devices must comply with the requirements of ISO 10993-17.

- Requirements and Changes: Understand the requirements of the standard and the specifics of recent revisions.

- Implementation: Understand when and how to effectively apply these changes.

The revised edition introduces a detailed process for TRA, including hazard identification, risk estimation, and risk assessment. It emphasizes the need for a systematic approach to assess potential risks associated with medical devices, taking into account factors such as material composition, manufacturing processes, and device usage.

Practical Tips

- Ensure all relevant data from clinical use is included in the analysis.

- Select meaningful chemical characterizations that comply with clinical applications and ISO 10993-18 requirements.

- Pay attention to the quality of toxicological data and thoroughly document it.

Adopting a conservative approach ensures patient safety.

Conclusion

With the update of ISO 10993-17:2023, medical device manufacturers face significant changes in how they assess and record toxicological risks. This revision not only strengthens patient safety but also requires manufacturers to deepen their understanding and rigorously implement evaluation processes. Keeping abreast of relevant information and being prepared are crucial for compliance and ensuring the safety and effectiveness of medical devices.