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New Requirements for the Toxicological Risk Assessment of Extractable and Leachable Components

As part of chemical characterization, our experts are ready to assist you with the toxicological assessment of extractable and leachable components following the latest requirements of ISO 10993-17:2023.

According to ISO 10993-1, the chemical characterization of materials used in medical devices is the initial step in the biological safety assessment process. The material characterization process must include at least an evaluation of all materials used in the product as well as potential residues from the manufacturing process (e.g., processing aids, additives). A comprehensive chemical characterization combined with a toxicological assessment also allows for the discussion of systemic endpoints in the biocompatibility assessment.

For the toxicological risk assessment of medical device components, the guidelines of ISO 10993-17 must be followed. The revised ISO guideline 10993-17 was released at the end of 2023 and includes many changes and new concepts for the toxicological risk assessment of medical device components. Based on this guideline, the general process can be divided into two parts:

  1. Risk identification in terms of identifying the components of the medical device that could be harmful for the clinical use of the device, and
  2. Estimation of the potential risk.

For risk estimation, a worst-case estimated exposure dose is typically derived for the substances under investigation, taking into account the intended use and clinical application of the medical device. Additionally, toxicological thresholds must be defined to assess the tolerable intake amount for each component. By relating the estimated exposure dose to the derived toxicological threshold, the safety margin (Margin of Safety/ MoS) is calculated. This MoS can be used to infer the potential risk of the substances within the clinical application of the medical device.

In conclusion, a comprehensive chemical characterization along with a subsequent toxicological risk assessment that excludes potential risks from extractable and leachable components during the clinical use of a medical device can be used for discussing certain endpoints in the biological safety assessment. A well-structured and planned chemical characterization can avoid some of the biggest challenges in toxicological assessments.

For more information about our services for risk assessment of extractable and leachable components, please visit our website (DACH region or worldwide).