Select Page

Updated ISO 10993-17:2023 Standard

Home 9 News 9 Updated ISO 10993-17:2023 Standard
ISO Logo

The ISO 10993 standard series covers the biological evaluation of medical devices. Part 17 of this series addresses the toxicological risk of chemical constituents resulting from the chemical characterization of medical devices. In its first major revision in 20 years, the new ISO 10993-17:2023 was published on 13 September. This update has consequences for all medical device manufacturers who must comply with the new requirements.

ISO 10993-17:2023 introduces some new concepts for toxicological risk assessments, such as toxicological screening limits (TSLs) and maximum estimated exposure dose (EEDmax), which will improve accuracy and reliability. These major changes will impact medical device manufacturers when they prepare to introduce or update products.

Our CTO, Carsten Baun Senholt, is a sitting member of the international technical committee TC 194, which designed the new standard. Therefore, our certified QMS and toxicological risk assessments are fully compliant.

Read more about how we can help you with ISO 10993-17 compliance:

Biological Evaluation Report
Safely Manage Change