Home Healthcare Equipment Testing
Testing of medical electrical equipment used in the home healthcare environment to IEC 60601-1-11, from environmental conditions to lay operators, with an ASCA summary test report for your FDA 510(k).
- IEC 60601-1-11
- IEC 60601-1
- IEC 60601-1-8
Why Sigma
Home use data FDA reviewers recognize
We test your device for the conditions it will meet outside the hospital, against the collateral standard for the home healthcare environment, in one program and one report.
- FDA ASCA-accredited for IEC 60601-1-11: your report comes with an ASCA summary test report for the 510(k).
- Built for lay operators: markings, instructions and alarms checked for people without medical training.
- The real home environment: mains, water, drops and cleaning, tested the way the device will be used.
- One program with IEC 60601-1: home use, alarms and electrical safety tested together for the same unit.
What we test
Every clause your submission needs
Tested for each configuration and accessory used at home, including portable and transportable versions. 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 60601-1-11 | Collateral standard: requirements for medical electrical equipment used in the home healthcare environment | ASCA · A2LA |
| IEC 60601-1 | General requirements for basic safety and essential performance | ASCA · A2LA |
| IEC 60601-1-8 | Collateral standard: alarm systems | ASCA · A2LA |
| IEC 60601-1-6 | Collateral standard: usability | 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 was designed for hospitals. Can it go home?”
We run a gap assessment against IEC 60601-1-11 and tell you which design and labeling changes the home environment needs.
“Which IP rating do we need?”
We map your use to the minimum protection against water and test the device to the rating you declare.
“Will it survive being dropped?”
We run the drop, shock and vibration tests for your device type and check it is still safe and works afterwards.
Your test report
A report ready to file
Clause-by-clause results with the conditions and measurements behind every verdict.
- Clause-by-clause verdicts for IEC 60601-1-11
- Environmental and supply mains conditions tested
- Ingress protection and mechanical strength results
- Cleaning and disinfection durability
- Review of markings and instructions for lay operators
- 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 60601-1-11 is within our ASCA scope, so you receive an ASCA summary test report for your 510(k).
When does IEC 60601-1-11 apply?
When the device is intended for use in the home or anywhere outside a professional healthcare facility where patients live, by the patient or a lay caregiver.
What do I need to send?
The device with its accessories and power supply, the instructions for use and the cleaning instructions. We send a checklist with the quote.
How fast can I get a quote?
Within 24 hours. Tell us the device, how and where it is used at home, and we reply with scope, price and timeline.
Request a home healthcare 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