Cytotoxicity Testing 101: Assays, Biocompatibility and Risk Management

Overview

Medical devices intended to come into contact with a patient's body or cell sample need to undergo a biological evaluation, specifically cytotoxicity testing. A cytotoxicity test is a highly sensitive and efficient test used for determining the safety profiles of materials used for medical devices.

This webinar will focus on the different assays involved in cytotoxicity testing, as well as their role and importance in biocompatibility testing for medical devices. 

Objective

In this webinar, the audience will learn about the different assays and sample categories used in cytotoxicity testing as per ISO 10993-5. The webinar will also focus on how to simplify steps for data interpretation, as well as the additional information you need to assess patient safety.

In addition, the presenters will cover the main similarities and differences between ISO 10993-5 and USP 87, before concluding with a case study on performing an investigation and risk assessment on devices that demonstrate cytotoxic reactivity.

We will also discuss why some devices might give positive results due to the high sensitivity of cytotoxicity testing, why a test failure is not a definitive conclusion and what possible next steps teams can take.

Agenda

• Introduction
• Industry regulations and expectations
• Types of cytotoxicity assays
• Challenges
• Case study
• Q&A