Panel Discussion: Recent Developments in ISO 10993 Series of Standards for Biocompatibility Testing and Evaluation

Timeslot: Thursday, April 4, 2019 - 4:15pm to 6:15pm
Track: Industry
Room: Yakima 2


This session will focus on the recent developments in biocompatibility testing for medical devices, especially on the recent revisions/updates on ISO 10993 series of standards and the FDA’s guidance document on the use of such standards. The industry speakers who are leading experts in the field of biocompatibility testing will be invited to participate in this session to talk about the history of ISO 10993-1, risk management for biocompatibility evaluations, general biocompatibility testing considerations, test-specific considerations, and chemical assessments including extractables and leachables. The speakers will also talk about biocompatibility regulations and guidance in compliance with applicable global regulatory requirements (FDA, ISO, MHLW, and CFDA) for Class I to Class III devices. This session would be of great interest to Industry members, biomedical scientists, students and faculties, and regulatory professionals.


Abstracts will be available for download on April 3, 2019.

  • 4:15 PM 309. Deanna Porter, Abbott

  • 4:45 PM 310. Kent Grove, Abbott

  • 5:15 PM 311. Don Phol, NAMSA

  • 5:45 PM 312. Cindy Dingee, WuXi AppTec