Biocompatibility

Risks of incorrect AET determinations in chemical characterization and toxicological risk assessment

The chemical characterization according to DIN EN ISO 10993-18:2023-11 and the toxicological risk assessment (TRA) according to DIN EN ISO 10993-17:2024-02 are essential components of the biological evaluation of medical devices. A critical parameter in this process is the Analytical Evaluation Threshold (AET).

The correct setting of the AET is crucial to ensure that all relevant extractables & leachables are evaluated. This article highlights the potential consequences of incorrectly defining the relevant variables to calculate the AET.

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