Choosing Appropriate Ultrasonic Measurement Standards
We’ve put together a guide on what ultrasonic measurement standards to follow, and what to do if you’re developing a technology which does not have a specific standard yet.
Determining the appropriate ultrasound measurement standard for your application can be tricky. Even if you are early in a design process, collecting your ultrasound characterization data in a way that is in line with existing standards will make it easier for future regulatory submissions and ensure your data is repeatable years into your design cycle.
This is the same process we use with every customer when they use our ultrasound measurement or device characterization services. We’ve just already spent hundreds of hours reading and applying these standards to our practices.
All Devices: IEC 62127
All ultrasonic measurement standards utilize and reference IEC 62127, which is the standard describing how to use a hydrophone. When in doubt, you can always refer to this standard for guidance on how to use a hydrophone, general signal processing techniques, and data acquisition considerations.
Imaging: IEC 62359, IEC 60601-2-37
These standards define the mechanical index, thermal indices, as well as various other reporting parameters for diagnostic imaging systems. As a bonus, IEC 60601-2-37 also provides output limits for imaging devices, which can be useful when trying to demonstrate the safety of a novel ultrasonic device
Elastography: IEC 63412, IEC 62359, IEC 60601-2-37
In addition to the diagnostic imaging requirements, IEC 63412 also provides specifications on the user interface for shear wave elastography systems.
Doppler: IEC TS 61206, IEC 61266, IEC TS 61895
Depending on the application and type of doppler system you are developing, there are different standards around the characterization techniques. These standards are from the 1990s, but if there any any updates we’ll be sure to post about it here.
Lithotripsy: IEC 61846, IEC 63045, IEC 60601-2-36
Lithotripters, or per updated nomenclature, ultrasonic short pressure pulses, have several standards which are applicable depending on the type of lithotripsy devices (focused or unfocused). IEC 60601-2-36 is a companion safety standard for extracorporeal devices.
Intravascular Lithotripsy: IEC 61846, IEC 63045, IEC 60601-2-36, IEC 63612 (In Development)
Intravascular lithotripsy is a relatively new technology that has seen widespread clinical adaption and investment. While current guidance is based on the existing lithotripsy standards, IEC 63612 is specifically designed for intraluminal applications. Fun fact: our CEO & Founder, Leela Goel Pawashe is the project leader for IEC 63612.
High Intensity Therapeutic Ultrasound (HITU): IEC 60601-2-62,IEC 62556, IEC TR 62649, IEC TS 63588 (In Development)
There are several guidance documents and standards regarding HITU field characterization. When in doubt, we recommend sticking with the IEC documents, rather than technical reports (TR) or technical specifications (TS) unless you have specific additional needs not addressed in the standards documents.
High Intensity Focused Ultrasound (HIFU): IEC 60601-2-62,IEC 62556, IEC TR 62649, IEC TS 63588 (In Development)
While there are no specific standards for high intensity focused ultrasound, the guidance from high intensity therapeutic ultrasound (HITU) is good enough for now.
Histotripsy: IEC TS 63001
Histotripsy is another emerging technology which does not have a specific standard to refer to. Given the cavitation fields generated, in addition to using IEC 62127 for general characterization, some considerations will be needed for measuring cavitation. We will be sure to update this page as additional guidance becomes available.
Neuromodulation and Brain Computer Interfaces (BCI): ITRUSST,IEC 60601-2-62,IEC 62359, IEC 60601-2-37
As neuromodulation and brain computer interface applications have grown in popularity, there have not been any established international standards guiding ultrasonic field outputs and characterizations. ITRUSST is an organization currently leading consensus and standardization efforts in the ultrasound neuromodulation space. However, our customers are often using the safety limits set by IEC 60601-2-37 while standardizations efforts are underway. We will be sure to update this page as additional guidance becomes available.
Neuromodulation and Brain Computer Interfaces (BCI): ITRUSST,IEC 60601-2-62,IEC 62359, IEC 60601-2-37
As neuromodulation and brain computer interface applications have grown in popularity, there have not been any established international standards guiding ultrasonic field outputs and characterizations. ITRUSST is an organization currently leading consensus and standardization efforts in the ultrasound neuromodulation space. However, our customers are often using the safety limits set by IEC 60601-2-37 while standardizations efforts are underway. We will be sure to update this page as additional guidance becomes available.
Industrial and Non-Medical Applications: IEC 60565, IEC TR 60886, IEC TS 63001, IEC TS 63081,IEC 63305
From ultrasonic cleaners, material characterization, or simply developing your own hydrophone, these standards are available for different types of applications.
And More!
Believe it or not, there are even more applications of ultrasound and standards that we haven’t gone over in the above sections. We’re here to bring your ideas to life by providing easy to use, practical ultrasound measurement solutions and connecting you with our network of consultants. Contact us today to see how we can bring these standards to your lab.
