The landscape of biocompatibility testing for medical devices is evolving with the recent shift of irritation assessment requirements from ISO 10993-10 to ISO 10993-23. This new standard marks a significant milestone by incorporating in vitro irritation testing, aligning with global efforts to reduce animal testing and integrate the principles of the 3 R’s (replace, reduce, refine) into biocompatibility evaluations. This webinar will provide an in-depth and informative discussion on ISO 10993-23, outlining the necessary steps to incorporate in vitro irritation testing into your biocompatibility program.
Understanding the in vitro testing method is crucial for effectively integrating it into biocompatibility assessments. The webinar will offer a comprehensive review of the in vitro irritation testing method, detailing the protocols and techniques involved. Participants will learn how this method provides a reliable and ethical alternative to traditional in vivo testing, reducing the reliance on animal models while still ensuring the safety and efficacy of medical devices.
Current regulatory acceptance of in vitro irritation testing is another critical topic that will be covered. The webinar will provide an update on the latest regulatory perspectives and acceptance criteria for in vitro irritation testing, highlighting how different regulatory bodies are embracing this method. Participants will gain an understanding of how to navigate the regulatory landscape and ensure compliance with the new ISO 10993-23 standard.
This webinar aims to equip manufacturers with the knowledge and tools to effectively incorporate in vitro irritation testing into their biocompatibility programs. By understanding the new ISO 10993-23 standard, reviewing the in vitro testing method, deciding when to pursue in vitro or in vivo testing, and learning how to transition from in vivo to in vitro testing, participants will be well-prepared to align their practices with current regulatory and ethical standards. This proactive approach will enhance the safety and efficacy of medical devices, reduce the reliance on animal testing, and ensure compliance with the latest biocompatibility requirements.