All medical devices intended to contact patients must undergo a rigorous biological evaluation to ensure their safety. The foundational guidance document for these biocompatibility assessments is ISO 10993-1, which provides a comprehensive framework for evaluating medical devices. This standard defines the relevant biological endpoints that need to be assessed based on the type and duration of contact the device will have with the patient. Among these endpoints, cytotoxicity is universally required for all devices within the scope of ISO 10993-1, regardless of the contact type.
Cytotoxicity testing is a critical component of biocompatibility assessments due to its high sensitivity, rapid turnaround time, and cost-effectiveness. This test is widely used in the medical device industry to screen devices for potential biological reactivity. However, the high sensitivity of cytotoxicity assays can sometimes result in elevated reactivity readings, necessitating further investigation to determine whether these results pose a real concern when the device is used in a clinical setting.
This webinar will provide a thorough introduction to the basics of cytotoxicity testing, including the principles and methodologies involved. Viewers will learn how to conduct cytotoxicity tests, interpret the results, and understand the implications of high reactivity findings. The session will also cover the steps involved in conducting a follow-up investigation and risk assessment for devices that exhibit cytotoxic reactivity. Real-world examples will illustrate how to navigate these challenges and make informed decisions about device safety.
By the end of this webinar, attendees will have a solid understanding of cytotoxicity testing within the context of ISO 10993-1, equipping them with the knowledge to perform effective biocompatibility evaluations and manage any reactivity concerns. This information is vital for design teams, quality assurance professionals, and regulatory personnel involved in the development and approval of medical devices, ensuring that their products meet the highest safety standards for patient use.