This presentation will discuss the recent and upcoming changes to regulatory documents and standards and how they will impact the overall biocompatibility assessment of medical devices. The webinar will include:
- Discussion about how biocompatibility assessments are affected by the recent updates to the ISO 10993-1 document and the new European MDRs.
- Anticipated changes to ISO 10993-18. Since the use of chemistry in the biocompatibility assessment of medical devices is gaining traction, the document that outlines how to use chemical characterization for these assessments is undergoing major revisions.
- Changes that are expected with the acceptance of in-vitro irritation testing.
- A thorough review of the impact of the recently-finalized ISO 18562 standard which specifically targets respiratory contact devices.
Thor Rollins- Director, Toxicology and E&L Consulting
Matt Jorgensen, PhD- Chemistry and Materials Scientist