Infant Incubator Testing
Basic safety and essential performance testing of infant incubators and infant transport incubators to IEC 60601-2-19 and IEC 60601-2-20, with an ASCA summary test report for your FDA 510(k).
- IEC 60601-2-19
- IEC 60601-2-20
- IEC 60601-1-8
Why Sigma
Incubator data FDA reviewers recognize
We test the thermal environment, the alarms and the safety of your incubator against its particular standard, in one program and one report.
- FDA ASCA-accredited for IEC 60601-2-19 and IEC 60601-2-20: your report comes with an ASCA summary test report for the 510(k).
- Stationary and transport incubators: both particular standards tested by the same team.
- Long, logged measurements: temperature, humidity and CO₂ recorded over the full test conditions.
- One program with alarms and electrical safety: IEC 60601-1-8 and IEC 60601-1 tested together for the same unit.
What we test
Every clause your submission needs
Tested in air-controlled and baby-controlled modes, at the settings 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 60601-2-19 | Particular requirements for the basic safety and essential performance of infant incubators | ASCA · A2LA |
| IEC 60601-2-20 | Particular requirements for the basic safety and essential performance of infant transport incubators | ASCA · A2LA |
| IEC 60601-1-8 | Collateral standard: alarm systems | ASCA · 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 temperature overshoots after a setpoint change.”
We log the full temperature response and show where it exceeds the limit, so you can tune the control before the formal test.
“Which tests apply to our transport incubator?”
We map your design to IEC 60601-2-20 and tell you which thermal, battery and mechanical tests the report needs.
“CO₂ builds up at low air flow.”
We measure CO₂ in the infant compartment under the specified conditions and report it against the limit.
Your test report
A report ready to file
Clause-by-clause results with the logged measurements behind every verdict.
- Clause-by-clause verdicts for IEC 60601-2-19 or IEC 60601-2-20
- Temperature control, uniformity and overshoot
- Humidity, oxygen and CO₂ measurements
- Air velocity and sound level
- Alarm and cut-out verification
- ASCA summary test report (within ASCA scope)
Accreditation
Accredited where it matters
Related services
Testing that usually goes with it
Resources
Learn more about IEC 60601 testing
FAQ
Frequently asked questions
Is the report accepted by FDA as an ASCA report?
IEC 60601-2-19 and IEC 60601-2-20 are within our ASCA scope, so you receive an ASCA summary test report for your 510(k).
Do you test transport incubators?
Yes. We test infant transport incubators to IEC 60601-2-20, including battery operation and the conditions of transport, together with the thermal tests.
How long do the thermal tests take?
Thermal tests need the incubator to reach steady conditions at each setting, so they run over several days. We give you the schedule with the quote.
How fast can I get a quote?
Within 24 hours. Tell us the incubator model, its modes and accessories, and we reply with scope, price and timeline.
Request an incubator 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