Alarm Systems Testing
Testing of alarm systems in medical electrical equipment to IEC 60601-1-8, from alarm priorities to auditory and visual alarm signals, with an ASCA summary test report for your FDA 510(k).
- IEC 60601-1-8
- IEC 60601-1
- ANSI/AAMI ES60601-1
Why Sigma
Alarm data FDA reviewers recognize
We record and measure every alarm signal your device produces and check the alarm system against the collateral standard, in one program and one report.
- FDA ASCA-accredited for IEC 60601-1-8: your report comes with an ASCA summary test report for the 510(k).
- Measured, not just observed: pulse timing, frequency content and sound pressure level recorded for each priority.
- Every alarm condition: priorities, delays, inactivation states and presets checked against your alarm list.
- One program with IEC 60601-1: alarm systems and electrical safety tested together for the same unit.
What we test
Every clause your submission needs
Tested for each alarm condition in your alarm list, in every operating 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 60601-1-8 | Collateral standard: general requirements, tests and guidance for alarm systems in medical electrical equipment | ASCA · A2LA |
| IEC 60601-1 | General requirements for basic safety and essential performance | ASCA · A2LA |
| ANSI/AAMI ES60601-1 | US national version of IEC 60601-1, recognized by FDA | 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 alarm sound doesn’t match the standard pattern.”
We record the signal and compare pulse timing and frequency content with the requirements, so you know exactly what to change.
“Is our visual alarm visible enough?”
We check color, flashing frequency and perceptibility from the specified position for each priority.
“Which alarm features does our device need?”
We review your alarm list and intended use, and tell you which clauses apply before formal testing.
Your test report
A report ready to file
Clause-by-clause results with the recordings and measurements behind every verdict.
- Clause-by-clause verdicts for IEC 60601-1-8
- Alarm conditions, priorities and delays
- Pulse timing and frequency of auditory signals
- Sound pressure levels per priority
- Visual signal color, flashing and perceptibility
- ASCA summary test report (within ASCA scope)
Accreditation
Accredited where it matters
Related services
Testing that usually goes with it
Resources
Learn more about alarm testing
FAQ
Frequently asked questions
Is the report accepted by FDA as an ASCA report?
IEC 60601-1-8 is within our ASCA scope, so you receive an ASCA summary test report for your 510(k).
Which devices need IEC 60601-1-8?
Any medical electrical equipment with an alarm system, such as patient monitors, infusion pumps, ventilators and incubators. Many particular standards add their own alarm requirements on top of it.
What do I need to send?
The device, its alarm list with priorities and delays, and the instructions for use. We send a checklist with the quote.
How fast can I get a quote?
Within 24 hours. Tell us the device, its alarm conditions and the standards you need, and we reply with scope, price and timeline.
Request an alarm systems 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