ISO 10993-10 Biological evaluation of Medical Devices - Test Standard for Irritation and Skin Sensitization

ISO 10993-10 describes the procedure for evaluating medical devices and their constituent materials for their potential for irritation and skin sensitization.

ISO 10993-10 includes:

• Pretest considerations for irritation including in silico and in vitro methods for dermal exposure;
• Details of in vivo (irritation and sensitivity) testing procedures;
• Key factors for interpretation of results.

Instructions for the preparation of materials are given specifically in relation to the above tests, and various specific irritation tests are described for the application of medical devices to areas other than the skin.

EUROLAB assists manufacturers with ISO 10993-10 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.