In recent years, significant changes have been made to the standards and practices surrounding biocompatibility testing, driven by the revisions to ISO 10993-1 and the introduction of ISO 10993-23. For the past three to four decades, biocompatibility testing has remained relatively unchanged, typically following a straightforward process: examining the device, comparing it to a standard chart, and performing the suggested tests. However, with the latest revisions, the field is moving towards reducing animal testing and adopting more alternative testing methods.
This webinar will delve into the most recent revisions to ISO 10993-1 and discuss the current and future states of alternative testing. The focus will be on the significant developments brought about by these changes and what they mean for the medical device industry.
The introduction of ISO 10993-23 marks a pivotal shift, as it allows for animal-free irritation testing to be performed alongside traditional animal-based methods. This change reflects a broader movement within the industry to minimize animal testing and explore alternative approaches that are both ethical and scientifically robust.
Key topics to be covered in this presentation include:
- The proposed changes to ISO 10993-1 and their implications for biocompatibility testing
- The general response of regulators regarding the adoption of alternative testing approaches
- The future outlook of ISO 10993-1, with an emphasis on continued reduction of animal testing and the development of new methodologies
Attendees will gain a comprehensive understanding of the recent revisions to ISO 10993-1 and the impact these changes will have on biocompatibility testing. The discussion will provide insights into the regulators’ perspectives on alternative testing methods and highlight the potential advancements in this field in the coming years.
By the end of the presentation, participants will have a clearer picture of the alternatives to animal testing currently available and those that may emerge in the near future. This knowledge is crucial for professionals involved in regulatory affairs, quality assurance, product development, and testing within the medical device industry.
Join us to explore the evolving landscape of biocompatibility testing and learn how to navigate the shift towards more humane and effective testing methodologies.