ISO TS 10974 Test for Magnetic Resonance Imaging for Patients with Implantable Medical Devices

EUROLAB laboratory provides testing and compliance services within the scope of ISO TS 10974 standard. This standard is applicable to implantable parts of active implantable medical devices (AIMDs) of cylindrical (circular or elliptical cross-section) diameter, intended for use in patients undergoing whole-body magnetic resonance scanning.

MR scanners operating at approximately 64 MHz with whole body coil excitation.

Requirements for non-replaceable parts are beyond the scope of this document.

The tests specified in this document are type tests that characterize interactions with magnetic and electromagnetic fields associated with an MR scanner. Tests can be used to demonstrate device operation according to MR Conditional labeling. The tests are not designed for use in routine testing of manufactured products.

Modification of these experiments for specific device types is left to specific product committees.

Other interested parties, such as device manufacturers, regulatory agencies, and specific product committees, are responsible for setting specific eligibility criteria and identifying risk.

Coverage is limited to AIMDs that do not use sensing functions or AIMDs that are programmed not to use sensing functions to affect therapy delivery during an MR scan

EUROLAB assists manufacturers with ISO TS 10974 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.