ISO 10993-4 Biological Evaluation of Medical Devices - Test Standard for Interactions with Blood

ISO 10993-4 specifies general requirements for evaluating the interactions of medical devices with blood.

This standard describes:

• Classification of medical devices intended for use in contact with blood according to the intended use and contact time defined in ISO 10993-1;
• The basic principles of the evaluation of the interaction of the devices with blood;
• The principles and scientific basis of these tests, as well as the rationale for the choice of tests structured according to certain categories.

Detailed requirements for testing cannot be established due to limitations in the knowledge and sensitivity of tests for evaluating devices' interactions with blood. This standard describes biological evaluation in general terms and may not provide adequate guidance for test methods for a particular device.

EUROLAB assists manufacturers with ISO 10993-4 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.