Are you ready for the significant changes coming to ISO 10993-1 and 3 in the very near future?

Kimberly Ehman, PhD, DABT, Head of Regulatory Toxicology, Eurofins Medical Device Services

There have been extensive discussions around the changes coming to ISO 10993-1, which is expected to be published this fall. Some of the major changes include emphasis on a risk-based approach, life cycle considerations, changes to calculation of exposure duration, and overall modifications to how medical devices will be categorized. As many devices will now be categorized differently, there may be additional testing requirements (e.g., genotoxicity) that were not previously considered in your previous test package. Also, ISO 10993-3, the standard for genotoxicity, carcinogenicity, and developmental and reproductive toxicity (DART), is also under revision and expected to move to Final Draft International Standard (FDIS) this fall. Here are highlights of some of the major changes coming to ISO 10993-3.

Eurofins toxicologists have been extensively involved in the development of both the ISO 10993-1 and -3 revised standards and are available to provide support if you have questions or concerns around how these changes may impact previous or new submissions.

ISO 10993-3 was last updated in 2014. During the last 11 years, there have been considerable shifts in the way biological endpoints can be addressed, particularly with respect to the use of chemical characterization and toxicological risk assessment. As such, the updates to the revised version of ISO 10993-3, which is currently a Draft International Standard (DIS), reflect these different approaches.

ISO 10993-3 is applicable when the need to evaluate a medical device for potential genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity has been established. The current version of the standard (2014) is titled “Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.” In the ISO/DIS 10993-3, the title has changed to “Biological evaluation of medical devices – Part 3: Evaluation of genotoxicity, carcinogenicity, reproductive toxicity, and developmental toxicity.” The updated title, which includes the addition of “developmental toxicity,” reflects several changes throughout the standard that focus on evaluation of these endpoints through the use of chemical characterization (ISO 10993-18) and toxicological risk assessment (ISO 10993-17). One of the main reasons for the shift in terminology from “test” to “evaluation,” particularly with carcinogenicity and DART endpoints, is due to the limitations and challenges that medical devices (or extracts) present in these biological assays. Some other significant changes include the addition of an annex on genotoxicity evaluation of nanomaterials, guidance around genotoxicity evaluations for constituents that are not easily detected using non-targeted chemical characterization approaches (e.g., aldehydes), and approaches for the evaluation of non-genotoxic carcinogenicity.

If you have any questions around the potential impact of ISO 10993-1 or -3 changes in your medical device testing program, Eurofins toxicologists are available to support your device-specific questions and help you design a test program that meets both current and upcoming regulatory requirements.