The normative environment for the biological evaluation of medical devices has changed significantly in recent years. The 2018 version of ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process has led to changes in the series, as ISO 10993-18 on chemical characterization of materials in 2019.

The year 2021 starts strong with the publication of the new version of ISO 10993-12 on sample preparation, as well as the new ISO 10993-23 standard specifically dedicated to irritation tests (previously contained in ISO 10993-10 with skin sensitization tests), which requires MD manufacturers to give preference to in-vitro testing whenever possible in order to avoid the systematic use of animal testing.

New versions of ISO standards 10993-2, 10993-5, 10993-10 and 10993-17 are also expected

Need help analyzing the impacts of these new versions and implementing the changes applied to your organization and products? Don’t hesitate to contact us, we will accompany you in all your projects.