New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents
22 September 2023
The new ISO 10991-17:2023 (Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents) has been published.
After more than 20 years, the standard replaces the previous version from 2002, introducing a lot of changes. The toxicological risk assessment within the biological evaluation process is described in total based on:
- toxicological information on constituents describing potential harms and the circumstances in which harm can occur;
- the derivation of a tolerable contact level or tolerable intake, or the selection of a threshold of toxicological concern;
- exposure dose estimation;
- the derivation of a MoS, where appropriate.
As stated in the introduction, the document is intended for use by toxicologists or other knowledgeable and experienced professionals, appropriately qualified by training and experience, capable of making informed decisions based upon scientific data and a knowledge of medical devices.
The new revision is also more extensive than the previous edition as it clarifies when a toxicological risk assessment is recommended, how to calculate the worst-case estimated exposure dose of a constituent and when the probability of occurrence of harm to health should be addressed by other means (e.g. frequency based dose-response (if available), probabilistic dose-response, or biological testing). It furthermore introduces and/or specifies new concepts for hazard assessment like read-across, in silico methods and methods to address additivity of harm.
With chemical information, according to ISO 10993-1:2018, being essential for all medical devices with either direct or indirect contact to the patient, the new standard has a very high relevancy for evaluating chemical information in all biological evaluations of medical devices.
For further information about how to implement the new standard in your biological evaluation plans and reports, please contact our experts.