Physiotherapy Ultrasound Testing
Basic safety and essential performance testing of ultrasonic physiotherapy equipment to IEC 60601-2-5, with field measurements to IEC 61689 and an ASCA summary test report for your FDA 510(k).
- IEC 60601-2-5
- IEC 61689
- IEC 60601-1
Why Sigma
Physiotherapy ultrasound data FDA reviewers recognize
We measure the ultrasonic field of each treatment head and test the equipment against its particular standard, in one program and one report.
- FDA ASCA-accredited for IEC 60601-2-5: your report comes with an ASCA summary test report for the 510(k).
- Field measurements to IEC 61689: output power, effective radiating area, beam non-uniformity ratio and effective intensity.
- Every treatment head and frequency: each applicator you market is measured and reported on its own.
- One program with IEC 60601-1: acoustic output and electrical safety tested together for the same unit.
What we measure
Every parameter on your label
Measured for each treatment head, frequency and output mode you declare. 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 60601-2-5 | Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment | ASCA · A2LA |
| IEC 61689 | Physiotherapy systems: field specifications and methods of measurement, 0.5 MHz to 5 MHz | A2LA |
| IEC 63045 | Non-focusing and ballistic pressure pulse sources: field characterization | A2LA |
| IEC 61846 | Pressure pulse lithotripters: characteristics of fields | A2LA |
| IEC 60601-1 | General requirements for basic safety and essential performance | ASCA · A2LA |
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 devices and for changes to cleared ones.
Your challenges, our solutions
What manufacturers ask us most
“Our measured ERA doesn’t match the label.”
We repeat the raster scan to IEC 61689 and show where the difference comes from, so you can correct the label or the design.
“Which treatment heads do we need to send?”
We map your applicators and frequencies to the measurements required and tell you which units to ship.
“The treatment head runs hot.”
We measure the applicator temperature in use and uncoupled, and report it against the limit in the particular standard.
Your test report
A report ready to file
Clause-by-clause results with the measurements behind every verdict, per treatment head.
- Rated output power and its accuracy
- Effective radiating area and beam non-uniformity ratio
- Effective intensity and beam type
- Acoustic working frequency and modulation
- Treatment head temperature and displayed values
- ASCA summary test report (within ASCA scope)
Additional A2LA accredited tests
Complementary pressure pulse measurements
These measurements are within our A2LA ISO/IEC 17025 scope.
Accreditation
Accredited where it matters
Related services
Testing for the rest of your ultrasound portfolio
Resources
Learn more about physiotherapy equipment
FAQ
Frequently asked questions
Is the report accepted by FDA as an ASCA report?
IEC 60601-2-5 is within our ASCA scope, so you receive an ASCA summary test report for your 510(k).
Do I need to send every treatment head?
Yes, each treatment head model and frequency you market is measured on its own, together with the generator it is used with. We confirm the number of units in the quote.
Do you measure pulsed modes?
Yes. We measure output in continuous and pulsed modes, including pulse duration, pulse repetition period and duty cycle.
How fast can I get a quote?
Within 24 hours. Tell us the device, its treatment heads and frequencies, and we reply with scope, price and timeline.
Request a physiotherapy ultrasound 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