UL Solutions Inc.
03/26/2025 | News release | Archived content
Key Updates to ISO 10993-17: 2023 Revisions for Biological Evaluation of Medical Devices
- White Paper
Key Updates to ISO 10993-17: 2023 Revisions for Biological Evaluation of Medical Devices
Stay informed with the latest revisions to ISO 10993-17 and get insight into the impact updated global safety standards for chemical risk assessment will have on medical devices.
The revised ISO 10993-17 standard marks its first significant update in nearly 20 years, introducing critical changes that impact the biological evaluation of medical devices. This resource highlights these updates, including new terminologies, risk management processes, and concepts like the Toxicological Screening Limit (TSL). Manufacturers who understand and implement these changes will be better equipped to meet compliance standards, streamline product approval processes and maintain market access.
What to expect:
- An overview of key terminology updates and their implications for device evaluation.
- Detailed explanation of the new Toxicological Screening Limit (TSL) concept and how to apply it.
- Insights into maximum exposure calculations (EEDmax) and the role of toxicological databases.
- Recommendations for addressing data gaps in chemical substance assessments.
Download now to help ensure your company's products are evaluated according to the most up-to-date biological safety standards.
X
Get connected with our sales team
Thanks for your interest in our products and services. Let's collect some information so we can connect you with the right person.
Please wait…
Thank you! We've received your request.
We'll review your message carefully and get back to you as quickly as possible. To help ensure that you receive our reply, please add our domain @insights.ul.com to your list of approved contacts.
Related content
Share: