IEC 60601-1 is a crucial tool for demonstrating compliance with regulatory requirements around the world, including the requirements for CE marking and FDA clearance.
The receipt of the certification allows BSD to add TUV safety mark to the MTX-180 system which will help the company to sell its product in a large volume as all hospitals and clinics in the US require a safety mark on equipment prior to purchase.
The MTX-180 is a compact, mobile, proprietary system that includes a microwave generator, single-patient-use disposable antennas, and a thermistor-based temperature monitoring system.
BSD claims that the design of the MTX-180 allows delivery of higher power levels of microwave energy using a single generator and allows the operator to quickly and easily control the treatment.
BSD president Harold Wolcott said that the receipt of this safety certification for the MTX-180 is a significant milestone for the company and critical for marketing the MTX-180 system in the US and Europe, as well as in most markets throughout the world.
