EN ISO 10993-20 Biological Evaluation of Medical Devices - Part 20: Principles and Methods for Immunotoxicology Testing of Medical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 10993-20 testing. EN ISO 10993-20 provides an overview of immunotoxicology with particular reference to the potential immunotoxicity of medical devices. Provides guidance on methods for testing the immunotoxicity of various types of medical devices.

EN ISO 10993-20 is based on several publications written by various groups of immunotoxicologists over the past few decades that include the development of immunotoxicology as a separate entity within toxicology.

International and European Standards are the main focus in demonstrating the safety and conformity of medical devices. There has been increasing interest over the past few years in the potential of medical devices to cause changes in the immune system. It was deemed necessary to provide guidance on how to address the adverse effects of medical devices on the immune system. Since there are no standardized tests, this standard provides a framework for how to approach immunotoxicity assessment.

The purpose of this standard is:

• To summarize the current state of knowledge in the field of immunotoxicology, including immunotoxicology assessment methods and their predictive value;
• To determine what the problems were and how they were resolved in the past.

Immunotoxicity testing can be performed using in vivo and in vitro assays. Unlike in vivo immunotoxicity testing, in vitro testing possibilities are limited as the models lack the complexity of the intact immune system. The value of in vitro methods that aid in the extrapolation of animal data to humans (by elucidating the mechanisms of toxicity) is even more limited because they have not yet been adequately developed and standardized. However, they can be useful as mechanics studies.

EUROLAB assists manufacturers with EN ISO 10993-20 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.