IEC EN 62563-1 Medical Electrical Equipment - Medical Imaging Systems - Part 1: Evaluation Methods

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of IEC EN 62563-1 test. IEC EN 62563-1 describes evaluation methods for testing medical image imaging systems. It is intended for practical tests that can be evaluated visually or measured using basic testing equipment. More advanced or more quantitative measurements can be made with these devices, but they are beyond the scope of this standard.

IEC EN 62563-1 applies to medical imaging systems that can display monochrome image information in the form of grayscale values ​​in color and grayscale imaging systems (eg, cathode ray tube (CRT) monitors, flat panel displays, projection system). This standard applies to medical imaging systems that are used for diagnostic (interpretation of medical images to provide clinical diagnosis) or imaging (display of medical images for medical purposes other than to provide medical interpretation) and therefore have special requirements in terms of image quality. Head-mounted imaging systems used to verify positioning and to operate the system are outside the scope of this standard.

Two types of tests can be performed on site or after installation. An acceptance test is performed after a new image display system is installed or major changes are made to existing imaging systems. As the display system can degrade over time, stability testing is performed by the user on a periodic cycle to verify that performance is maintained for its intended use.

The standard describes various evaluation methods without specifying which specific tests to use for acceptance or stability tests. Rather, this standard is intended to be a reference for other standards and guidelines specific to each modality, or to be defined by national authorities who will refer to the assessment methods of this standard and refer to limiting values ​​and frequencies for acceptance and stability tests.

EUROLAB assists manufacturers with IEC EN 62563-1 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.