Toxicological risk assessment of medical devices by ISO 10993-17

Toxicological risk assessment by the ISO 10993-17 standard is essential for determining the biocompatibility of a medical device. After chemical characterization (ISO 10993-18) is performed to identify and quantify extractable and leachable substances, a toxicological risk assessment is necessary to evaluate the potential health risks associated with these chemicals.

ISO 10993-17 provides a structured approach to establishing the safe exposure levels of leachable substances in medical devices. Toxicological reports written for medical devices under this standard evaluate the findings from the leachables extraction for substances that may cause health effects in humans. Comprehensive risk assessments are created using toxicological data from existing literature, and mathematical tools when data on particular substances are unavailable. 

A toxicological risk assessment will include:

• A summary of the toxicological profile of substances flagged from the device's chemical characterization and determination of their respective permissible exposure limits.

• A calculation of the margin of safety between actual patient exposure and permissible exposure limits, considering various toxicological endpoints.

• A final assessment of whether a leachable poses a significant toxicological risk, including recommendations on ensuring compliance with safety thresholds.

The displayed starting price applies to the evaluation of a single extractable chemical. Generally, multiple chemicals are evaluated during the risk assessment, and the price per chemical decreases when more chemicals are included.

The extent of the required toxicological evaluation depends on the results of the ISO 10993-18 chemical characterization, which we can also offer. You can contact our experts through the form below to request a quote tailored to your medical device.