Medical devices that employ ultrasound technology are widely used in almost all medical specialties in the diagnosis and treatment of a variety of medical conditions. Because of the unique types of risk that they pose to patients, ultrasonic medical devices must undergo highly specialised testing and evaluation intended to reduce potential risks associated with excessive or unintended ultrasound output or heating of device probes. However, many manufacturers of ultrasonic medical devices lack the in-house expertise or testing capabilities to conduct this type of testing.
Depending on their specific application, ultrasonic medical devices utilise high frequency sound waves to create images of internal human tissues for diagnostic purposes, or to warm tissue for therapeutic effect. In either case, safety and performance parameters of ultrasonic medical devices must be tightly controlled to avoid overheating or damaging tissue.
For these reasons, the testing of ultrasonic medical devices generally focuses on the control and performance accuracy of the device, in order to ensure the safety of their use with patients. Other testing issues include an assessment of the potential for signal distortion that can lead to measurement errors of diagnostically relevant parameters, and the accuracy of safety-related indications displayed by a device.
The complexity of ultrasound testing typically requires the use of sophisticated measurement equipment, carefully calibrated testing devices and laboratory personnel experienced in ultrasound testing. For this reason, even the most advanced testing laboratories often require the services of an independent laboratory equipped to conduct ultrasound testing.
Specialised testing of ultrasonic medical devices is required to demonstrate compliance with the essential requirements of the European Medical Device Directive (93/42/EEC), as well as regulations of the U.S. Food and Drug Administration (FDA) and other regulatory authorities around the world. Therefore, manufacturers and distributors of ultrasonic medical devices must undergo ultrasound testing to gain legal access to these important markets.
TÜV SÜD’s medical device testing facility in Munich, Germany includes a state-of-the art ultrasound testing laboratory fully equipped to conduct all acoustical testing required for ultrasonic medical devices that fall under the scope of the IEC 60601-1 series of standards. This includes physiotherapy devices (IEC 60601-2-5) diagnostic devices (IEC 60601-2-37) and high-intensity therapeutic ultrasound devices (IEC 60601-2-62).
Our ultrasound testing laboratory is capable of measuring devices for acoustic fields and acoustic power up to 40 MHz. We can also conduct measurements in accordance with EN 61157 and FDA requirements (track 1 and track 3), as well as FDA requirements related to Doppler sensitivity and accuracy. And, we are equipped to conduct testing and collect measurements on ultrasound surgery and HITU systems.
TÜV SÜD Product Service is an EU Notified Body for medical devices, including ultrasonic medical devices, and is also accredited under the IECEE’s CB Scheme to test medical devices to standards that address ultrasound requirements. We can also qualify manufacturer’s own laboratories to participate in the so called MTL (Manufactureres Test Laboratory) program, so that manufacturers can use their own measurements to qualify their devices. We are also accredited by the Independent Laboratory Accreditation Cooperation (ILAC) for the testing of medical devices, facilitating the acceptance of our testing data by laboratories and regulators around the world.
We also provide a range of testing services for medical devices including EMC testing and electrical safety testing.
TÜV SÜD offers a complete range of testing, certification and auditing services to medical device manufacturers, helping them to manage risks and to protect and promote the health and safety of patients. With world-class medical device testing laboratories that utilise state-of-the-art equipment, we can evaluate your products for compliance with international standards and national regulations in every major medical device market. Our global network of more than 400 dedicated medical health and services professionals include noted scientists and physicians recognised as authorities in their respective fields. These combined capabilities make TÜV SÜD the preferred single source for worldwide compliance with medical device regulations