Get Started with TÜV SÜD
Request our services for your ultrasonic medical devices testing needs.
What is ultrasonic medical devices testing?
Medical devices that employ ultrasound technology are widely used for diagnosis and treatment in almost all medical specialties. Because of the unique types of risk they pose to patients, ultrasonic medical devices must undergo highly specialised testing and evaluation. This will reduce potential risks from excessive or unintended ultrasound output or heating of device probes.
Many manufacturers lack the in-house expertise or capabilities to conduct this type of testing. This is where an independent third-party such as TÜV SÜD can help by providing globally trusted testing expertise.
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, ultrasonic medical devices testing generally focuses on the control and performance accuracy of the device, 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 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 such as those provided by TÜV SÜD.
Many manufacturers lack the in-house expertise or capabilities to conduct this type of testing. This is where an independent third-party such as TÜV SÜD can help by providing globally trusted testing expertise.
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, ultrasonic medical devices testing generally focuses on the control and performance accuracy of the device, 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 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 such as those provided by TÜV SÜD.
Why ultrasonic medical devices testing is important
Only specialised ultrasonic medical devices testing can demonstrate that a medical device with the essential requirements of the European Medical Device Directive (93/42/EEC), GSPRs of the Medical device regulation EU-MDR 2017/745, 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.
How TÜV SÜD can help you with ultrasonic medical devices testing
TÜV SÜD offers a complete range of testing, certification and auditing services to medical device manufacturers. This helps you manage risks and protect and promote the health and safety of patients.
We are an EU Notified Body for medical devices, including ultrasonic medical devices. We are also accredited under the IECEE’s CB Scheme to test medical devices to standards that address ultrasound requirements.
With world-class medical device testing laboratories and state-of-the-art equipment, we can evaluate your products for compliance with regulations in every major medical device market.
Our global network of more than 400 dedicated medical health and services professionals includes noted scientists and physicians recognised as authorities in their respective fields.
These combined capabilities make TÜV SÜD the preferred partner for worldwide compliance with medical device regulations.
We are an EU Notified Body for medical devices, including ultrasonic medical devices. We are also accredited under the IECEE’s CB Scheme to test medical devices to standards that address ultrasound requirements.
With world-class medical device testing laboratories and state-of-the-art equipment, we can evaluate your products for compliance with regulations in every major medical device market.
Our global network of more than 400 dedicated medical health and services professionals includes noted scientists and physicians recognised as authorities in their respective fields.
These combined capabilities make TÜV SÜD the preferred partner for worldwide compliance with medical device regulations.
What our ultrasonic medical devices testing service includes
TÜV SÜD’s ultrasonic medical devices 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) and FDA requirements related to Doppler sensitivity and accuracy. We are also equipped to conduct testing and collect measurements on ultrasound surgery and HITU systems.
We can also qualify a manufacturer’s own laboratories to participate in the so-called MTL (Manufacturers 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.
Beyond ultrasound testing, we also provide a wider range of testing services for medical devices including EMC testing and electrical safety testing.
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) and FDA requirements related to Doppler sensitivity and accuracy. We are also equipped to conduct testing and collect measurements on ultrasound surgery and HITU systems.
We can also qualify a manufacturer’s own laboratories to participate in the so-called MTL (Manufacturers 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.
Beyond ultrasound testing, we also provide a wider range of testing services for medical devices including EMC testing and electrical safety testing.
Start your journey with us.
