Ultrasound Gel & Materials Testing
Acoustic and physical testing of ultrasound coupling gels and probe covers, from speed of sound and attenuation to viscosity and pH, with data for design, equivalence and your FDA 510(k).
- Speed of sound
- Acoustic attenuation
- Acoustic impedance
Why Sigma
Show that your material does not degrade the image
Gels and probe covers sit between the transducer and the patient. We measure how they affect the ultrasound and report it the way design reviews and FDA submissions need.
- Acoustic properties measured: speed of sound, attenuation and impedance, the values that decide image quality.
- Physical properties too: density, viscosity, pH and conductivity in one program.
- From the acoustic output team: the same lab that characterizes ultrasound fields to IEC 62127-1.
- One program: gel and ultrasound system can be tested together, by the team behind our accredited acoustic output testing.
What we measure
Acoustic and physical properties
Measured for each gel formulation or cover material, unaged and aged. See how we measure →
Methods we use
Methods and accreditation status
These measurements follow Sigma’s documented methods. Acoustic output of the ultrasound system itself is FDA ASCA accredited and can be tested in the same program.
| Measurement | Method | Accreditation |
|---|---|---|
| Speed of sound | Transit time of an ultrasound pulse through a sample of known thickness | Sigma method |
| Acoustic attenuation | Insertion loss through the sample across frequency | Sigma method |
| Acoustic impedance | Calculated from measured density and speed of sound | Sigma method |
| Density, viscosity, pH, conductivity | Laboratory measurements at controlled temperature | Sigma method |
| IEC 60601-2-37 · IEC 62127-1 | Acoustic output of diagnostic ultrasound systems. See acoustic output → | ASCA · A2LA |
Need a specific method? Contact us; we will tell you whether we can run it and how it would be reported.
When you need it
From formulation to production
Objective material data at every stage of the product life cycle.
Your challenges, our solutions
What manufacturers ask us most
“Does our probe cover reduce image quality?”
We measure attenuation and impedance of the cover, so you know how much signal it costs and whether it matters.
“Is the aged gel still equivalent?”
We test aged and unaged samples with the same methods and report the differences side by side.
“We need to compare against the predicate.”
We measure both products under the same conditions, so the comparison holds up in review.
Your test report
A report ready for review
Every measured property, with the setup, the methods and the conditions of the test.
- Measurement setup and test methods
- Speed of sound and acoustic attenuation
- Density and acoustic impedance
- Viscosity, pH and conductivity
- Aged versus unaged comparison
- Gel and system tested in one program
Accreditation
Engineering tests from an accredited lab
Related services
Testing for the rest of your ultrasound portfolio
Resources
Learn more about ultrasound testing
FAQ
Frequently asked questions
Can you test the gel and the ultrasound system together?
Yes. Gel and probe cover measurements follow Sigma’s documented methods, and acoustic output of the ultrasound system is FDA ASCA accredited. Both can be tested in the same program.
Can I use the results in a 510(k)?
Yes, as performance data. The report describes the setup, the methods and the results, so reviewers can follow how each value was obtained.
What do I need to send?
Samples from each formulation or lot, and aged samples if you need an equivalence comparison. We confirm the quantities in the quote.
How fast can I get a quote?
Within 24 hours. Tell us the material, the properties you need and the intended use, and we reply with scope, price and timeline.
Request a gel and materials testing quote
Tell us about your device and the standards you need. You’ll have a quote within 24 hours.
(305) 239-4441 info@sigmascientific.us 490 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33325