Accredited testingFDA ASCA · A2LA
Endoscope optical performanceISO 8600 series · A2LAEndoscope safetyIEC 60601-2-18Ultrasound acoustic outputIEC 60601-2-37 · IEC 62127-1Physiotherapy ultrasoundIEC 60601-2-5High intensity therapeutic ultrasoundIEC 60601-2-62Electrical safetyIEC 60601-1 · ANSI/AAMI ES60601-1Alarm systemsIEC 60601-1-8Home healthcare equipmentIEC 60601-1-11Usability & human factorsIEC 60601-1-6Infant incubatorsIEC 60601-2-19 · IEC 60601-2-20
FDA ASCA accredited laboratory
TL-114
11 standards in our ASCA scope, plus A2LA ISO/IEC 17025 accreditation 4896.01.
View our ASCA scope
Get a quote in 24 hours
Guides & help
Consult a specialist
(305) 239-4441
Not sure which standards apply to your device? We help you scope the test plan before you ship samples.
Find your standards
Menu
Accredited testing · FDA ASCA · A2LAEndoscope optical performanceISO 8600 series · A2LAEndoscope safetyIEC 60601-2-18Ultrasound acoustic outputIEC 60601-2-37 · IEC 62127-1Physiotherapy ultrasoundIEC 60601-2-5High intensity therapeutic ultrasoundIEC 60601-2-62Electrical safetyIEC 60601-1 · ANSI/AAMI ES60601-1Alarm systemsIEC 60601-1-8Home healthcare equipmentIEC 60601-1-11Usability & human factorsIEC 60601-1-6Infant incubatorsIEC 60601-2-19 · IEC 60601-2-20
Materials testingUltrasound gels and probe coversSpeed, impedance, viscosity, pH
All services →Measurements →
Accreditations
About Us
Latest insightsAcoustic Output Measurement Medical DevicesJuly 1, 2026All insights →Guides & helpASCA program guideWhat ASCA is, which standards it covers and how it speeds up your 510(k).FAQsSamples, timelines, reports and accreditation scope, answered.Standards finderPick your device type and see which standards apply.
Contact
Request a Quote(305) 239-4441
- Home
- Insights
Insights for medical device testing
Practical guidance from our scientists, engineers and regulatory professionals on acoustic output, electrical safety, FDA ASCA and getting your device ready for submission.
- Acoustic output
- FDA ASCA
- Testing strategy
- IEC 60601
3 articles3 topicsReviewed by Sigma test experts
Have a question about your device?
Our scientists, engineers and regulatory professionals help you scope standards, samples and timeline before you ship.
Consult with a medical device test expert
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