HITU Testing
Basic safety and essential performance testing of high intensity therapeutic ultrasound equipment to IEC 60601-2-62, with acoustic power and focal field measurements and an ASCA summary test report for your FDA submission.
- IEC 60601-2-62
- IEC 62555
- IEC TS 62556
Why Sigma
HITU data FDA reviewers recognize
We measure the focused acoustic field of your system and test the equipment against its particular standard, in one program and one report.
- FDA ASCA-accredited for IEC 60601-2-62: your report comes with an ASCA summary test report for the submission.
- Power and field measurements: acoustic power to IEC 62555 and focal field parameters to IEC TS 62556.
- Experience with high output: the same team that characterizes diagnostic and physiotherapy ultrasound fields.
- One program with IEC 60601-1: acoustic output and electrical safety tested together for the same system.
What we measure
The focused field, measured and reported
Measured for each transducer and each output setting 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 60601-2-62 | Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment | ASCA · A2LA |
| IEC 62555 | Power measurement for HITU transducers and systems | Via IEC 60601-2-62 |
| IEC TS 62556 | Specification and measurement of field parameters for HITU transducers and systems | Via IEC 60601-2-62 |
| 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
“How do you measure the field at full therapeutic power?”
We measure acoustic power at full output by radiation force, and map the focal field following the methods in IEC TS 62556.
“Which parameters belong in our submission?”
We map your system to the particular standard and tell you which power and field values the report needs to include.
“Our focal zone doesn’t match the design.”
We scan the field around the focus and show where the difference comes from, so you can correct the design or the label.
Your test report
A report ready to file
Clause-by-clause results with the measurements behind every verdict, per transducer and setting.
- Clause-by-clause verdicts for IEC 60601-2-62
- Acoustic output power and its stability
- Focal pressure and focal zone dimensions
- Beam profiles around the focus
- Displayed values and protection against excess output
- ASCA summary test report (within ASCA scope)
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
Is the report accepted by FDA as an ASCA report?
IEC 60601-2-62 is within our ASCA scope, so you receive an ASCA summary test report for your submission.
What is HITU equipment?
High intensity therapeutic ultrasound equipment focuses ultrasound energy to treat tissue, for example by heating it. It is often called HIFU. IEC 60601-2-62 sets its particular safety and performance requirements.
What do I need to send?
The system with each transducer you market, its coupling accessories and the settings you declare. We confirm the configurations and number of units in the quote.
How fast can I get a quote?
Within 24 hours. Tell us the system, its transducers and output settings, and we reply with scope, price and timeline.
Request a HITU 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