Electrical Safety Testing
Basic safety and essential performance testing of medical electrical equipment to IEC 60601-1 and ANSI/AAMI ES60601-1, with an ASCA summary test report for your FDA 510(k).
- IEC 60601-1
- ANSI/AAMI ES60601-1
- IEC 60601-1-8
- IEC 60601-1-11
Why Sigma
Electrical safety data FDA reviewers recognize
We test your device against the general standard for medical electrical equipment and the collateral and particular standards that apply to it, in one program and one report.
- FDA ASCA-accredited for IEC 60601-1 and ANSI/AAMI ES60601-1: your report comes with an ASCA summary test report for the 510(k).
- A2LA ISO/IEC 17025 accredited test methods, with calibrated equipment traceable to national standards.
- Collateral and particular standards together: alarm systems, home use, usability and the particular standards in our scope, in the same test program.
- Clear findings: if something fails, we show you where and why, and retest only what the fix affects.
What we test
Every clause your submission needs
Tested in normal condition and single fault condition, for each configuration and applied part. 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 | General requirements for basic safety and essential performance of medical electrical equipment | ASCA · A2LA |
| ANSI/AAMI ES60601-1 | US national version of IEC 60601-1, recognized by FDA | ASCA · A2LA |
| IEC 60601-1-8 | Collateral standard: alarm systems | ASCA · A2LA |
| IEC 60601-1-11 | Collateral standard: equipment used in the home healthcare environment | ASCA · A2LA |
| IEC 60601-1-6 | Collateral standard: usability. See usability testing | ASCA · A2LA |
| Particular standards | IEC 60601-2-5, -2-18, -2-19, -2-20, -2-37 and -2-62, tested together with IEC 60601-1 | 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 device failed leakage current at another lab.”
We measure where the leakage comes from, review the insulation diagram with you and retest after the fix.
“Which collateral and particular standards apply to us?”
We map the standards to your device and its intended use before we quote, so the test plan has no gaps.
“Our risk management file is not final yet.”
We tell you which risk management items IEC 60601-1 testing relies on, so the test does not stall.
Your test report
A report ready to file
Clause-by-clause results with the measurements and evidence behind every verdict.
- Clause-by-clause verdicts for IEC 60601-1 and applicable collateral standards
- Leakage current, dielectric strength and temperature measurement data
- Photos of the device, the test setup and markings
- Test equipment list with calibration traceability
- Non-conformities, if any, with the clause and evidence
- ASCA summary test report (within ASCA scope)
Additional tests
Complementary electrical tests
Component and accessory tests that complete your electrical safety program.
Accreditation
Accredited where it matters
Related services
Testing that usually goes with it
Resources
Learn more about electrical safety
FAQ
Frequently asked questions
Is the report accepted by FDA as an ASCA report?
IEC 60601-1 and ANSI/AAMI ES60601-1 are within our ASCA scope, so you receive an ASCA summary test report for your 510(k).
Can you test to IEC 60601-1 and ANSI/AAMI ES60601-1 at the same time?
Yes. One test program covers both, and the report shows the national differences that apply in the US.
What do I need to send?
The device and its accessories, the instructions for use, the risk management file, the insulation diagram and the list of critical components with their certificates. We send a checklist with the quote.
How fast can I get a quote?
Within 24 hours. Tell us the device, its applied parts and the standards you need, and we reply with scope, price and timeline.
Request an electrical safety 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