The main purpose of ISO 10993-1 is to emphasize a risk-based approach for evaluating the biocompatibility of medical devices, ensuring patient safety. A secondary, but equally important, goal of the document is to promote animal welfare by minimizing the number and extent of animal tests. The 2018 introduction of the requirement for a biological evaluation plan in ISO 10993-1, along with the increased reliance on chemical and physical information to assess the necessity of in-vivo testing, marks a significant step towards reducing the use of laboratory animals.
This webinar will focus on the journey towards an animal-free testing environment for evaluating the biological safety of medical devices. It will provide a detailed overview of the current status of animal-free test methods and explore the advancements being made in this area.
Attendees will learn about the principles of the risk-based approach outlined in ISO 10993-1, including how it helps identify potential biological risks without immediately resorting to animal testing. The presentation will discuss the development and implementation of biological evaluation plans, which integrate chemical and physical data to determine the need for in-vivo testing.
Furthermore, the presentation will highlight the progress and current status of alternative test methods that do not involve animals. These methods, which include in-vitro and computational models, offer promising avenues for assessing biocompatibility while adhering to the principles of animal welfare. Participants will gain insights into the effectiveness and reliability of these alternative methods and how they can be incorporated into biocompatibility evaluations.
By understanding the road towards an animal-free testing environment, professionals in the medical device industry can contribute to the advancement of more humane and scientifically robust methods for ensuring the safety of medical devices. This presentation is essential for those involved in regulatory affairs, quality assurance, product development, and testing, as it provides a comprehensive understanding of the current landscape and future direction of biocompatibility testing.
Join us to explore the innovative approaches being developed to evaluate the biological safety of medical devices while minimizing the use of animal testing, and learn how to implement these practices in your organization to ensure compliance and ethical responsibility.