Understanding ISO/DIS 10993-3 Updates: A Focus On Developmental And Reproductive Evaluations (DART) For Medical Devices

Major revisions are coming to the ISO 10993 series, including expected updates to ISO 10993-1 (Biological evaluation) and ISO 10993-3 (Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity).

The updated standards place a strong emphasis on a risk-based approach, life cycle considerations, and modifications to how medical devices are categorized. This means many devices may require different or additional testing, such as genotoxicity, compared to previous test packages.

Specifically, the revision to ISO 10993-3 reflects considerable shifts in how biological endpoints are addressed, moving the focus from physical testing to comprehensive evaluation. The revised standard integrates the use of chemical characterization (ISO 10993-18) and toxicological risk assessment (ISO 10993-17) for endpoints like carcinogenicity and developmental/reproductive toxicity (DART). The title has been updated to explicitly include "developmental toxicity." Other key changes include new guidance for genotoxicity evaluation of nanomaterials and approaches for non-genotoxic carcinogenicity.