EN 62366-1 Medical Devices - Testing for Usability Engineering

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN 62366-1 test. This standard specifies a process for a manufacturer to analyze, specify, develop and evaluate the usability of a medical device with respect to safety.

This usability engineering (human factors engineering) process allows the manufacturer to assess and reduce the risks associated with correct use and handling errors, i.e. normal use.

It can be used to identify risks associated with abnormal use, but does not assess or reduce them. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2 (not yet published), supersedes and supersedes the first edition of IEC 2007 published in 62366 and Amendment 1:2014.

Chapter 1 has been updated to include contemporary concepts of usability engineering while modernizing the process. Strengthens links to ISO 14971:2007 and related risk management methods applied to security-related aspects of medical device user interfaces.

Part 2, once published, will contain tutorials to help manufacturers comply with Part 1, as well as provide more detailed descriptions of usability engineering methods that can be applied more generally to medical devices that go beyond the safety-related aspects of the medical device user.

EUROLAB assists manufacturers with EN 62366-1 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.