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.
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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
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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.
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Tell us about your device, the standards, your timeline and your samples. A specialist replies with a quote and a test plan within 24 hours.
- Quote in 24 hours
- Test plan before samples ship
- ASCA summary reports
What happens next
From request to report
QuoteWithin 24 hours, with the standards, price and schedule.
Test planSamples, configurations and acceptance criteria agreed before testing.
SamplesYou ship to our Sunrise lab; we register and inspect them on arrival.
TestingProgress updates as each standard is completed.
ReportsComplete test reports and ASCA summary test reports for your submission.
Shipping samples
Before you ship
Ship to
Sigma Scientific Services490 Sawgrass Corporate Parkway, Suite 130
Sunrise, FL 33325, USA
Write your quote number on the box and email the tracking number to info@sigmascientific.us.
Include in the box
- The units agreed in the test plan
- All probes, cables, chargers and accessories used in normal operation
- Instructions for use and service manual
- Software, service mode or test mode access
- A contact name for technical questions
