Ultrasound Acoustic Output Testing
Hydrophone-based acoustic output measurement for diagnostic ultrasound systems and transducers, with a submission-ready report for FDA 510(k) and international approvals.
- IEC 60601-2-37
- IEC 62127-1
- IEC 62359
- AIUM/NEMA UD 2
Why Sigma
Acoustic output data FDA reviewers recognize
We measure the spatial and temporal characteristics of your ultrasonic field so you can show the system stays within safety limits and FDA preamendment values.
- FDA ASCA-accredited for IEC 60601-2-37: your report comes with an ASCA summary test report for the 510(k).
- A2LA ISO/IEC 17025 accredited hydrophone measurements to IEC 62127-1 and IEC 62359.
- Statistics built in: at least three transducers per imaging mode, with uncertainty analysis, so values near preamendment limits hold up in review.
- One report, several markets: prepared for submissions to the US FDA, Health Canada, Japan and Europe.
What we measure
Every field variable your submission needs
Measured in autoscanning and non-autoscanning modes, for each transducer and imaging mode. See how we measure →
Standards we test to
Standards and accreditation status
Each result is reported under the accreditation that covers it.
| Standard | Scope | Accreditation |
|---|---|---|
| IEC 60601-2-37 | Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | ASCA · A2LA |
| IEC 62127-1 | Hydrophones: measurement and characterization of medical ultrasonic fields | A2LA |
| IEC 62359 | Field characterization: test methods for the thermal and mechanical indices | A2LA |
| AIUM/NEMA UD 2 | Acoustic output measurement standard for diagnostic ultrasound equipment | A2LA |
| JIS T 1501 | Performance of pulse-echo ultrasound imaging equipment (image quality) | A2LA |
| FDA guidance (June 27, 2019) | Marketing clearance of diagnostic ultrasound systems and transducers | Followed |
Don’t see your standard? Contact us; we will tell you whether we can test to it and how it would be reported.
When you need it
From first submission to post-market
Support across the product life cycle, for new systems and for changes to cleared ones.
Your challenges, our solutions
What manufacturers ask us most
“Our ISPTA is close to the preamendment limit.”
We test more units to reduce the standard deviation and report the statistics the reviewer needs.
“We have many modes and probes. Where do we start?”
We build a test plan with you that covers the worst-case combinations without testing what is not needed.
“We are filing in several countries.”
One measurement campaign, with a report that cites both FDA guidance and the IEC standards.
Your test report
A report ready to file
Clear tables, the plots reviewers look for, and the traceability behind every number.
- Maximum field variables per mode
- Pulse waveform and PII plots
- Statistical and uncertainty analysis
- Measurement system and process description
- Hydrophone calibration
- ASCA summary test report (within ASCA scope)
Additional tests
Complementary ultrasound tests
Tests that complete your acoustic output program.
Accreditation
Accredited where it matters
Related services
Testing for the rest of your ultrasound portfolio
Resources
Learn more about acoustic output
FAQ
Frequently asked questions
How many transducers do I need to send?
At least three units per transducer model and imaging mode. If a value is close to a limit, more units reduce the standard deviation; we tell you before you ship.
Is the report accepted by FDA as an ASCA report?
Testing to IEC 60601-2-37 is within our ASCA scope, so you receive an ASCA summary test report.
What do I need to ship with the system?
The system, the transducers, operating instructions and access to the service or engineering modes needed to drive maximum output. We send a checklist with the quote.
How fast can I get a quote?
Within 24 hours. Tell us the device, the transducers and the modes, and we reply with scope, price and timeline.
Request an acoustic output 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