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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Medical device testing
Testing services for medical devices
Safety and performance testing to the standards FDA recognizes, run in our FDA ASCA and A2LA ISO/IEC 17025 accredited lab in Sunrise, Florida.
Ultrasound Acoustic Output TestingHydrophone-based measurement of diagnostic ultrasound fields to IEC 60601-2-37, IEC 62127-1, IEC 62359 and AIUM/NEMA UD 2, with a submission-ready report and ASCA summary for your FDA 510(k).
Electrical Safety and Essential PerformanceBasic safety and essential performance testing to IEC 60601-1 and ANSI/AAMI ES60601-1, including leakage current, dielectric strength, alarm systems (IEC 60601-1-8) and home healthcare equipment (IEC 60601-1-11).
Endoscope Safety and Optical PerformanceEndoscope safety under IEC 60601-2-18 in our ASCA scope, plus optical performance to the ISO 8600 series: resolution, field of view, direction of view and color reproduction.
Physiotherapy and HITU EquipmentTesting for ultrasonic physiotherapy equipment to IEC 60601-2-5 and high intensity therapeutic ultrasound to IEC 60601-2-62, from acoustic output to basic safety.
Infant Incubator TestingBasic safety and essential performance of infant incubators and infant transport incubators to IEC 60601-2-19 and IEC 60601-2-20.
Usability and Human FactorsUsability engineering evaluation of medical electrical equipment to IEC 60601-1-6, supporting the human factors file for your submission.Sigma’s solutions for medical devices
Safety and performance testing to the standards FDA recognizes, from protocol to submission-ready report.
Acoustic Output & Diagnostic UltrasoundUltrasonic field measurement and transducer temperature rise. IEC 60601-2-37, IEC 62127-1, IEC 62359, AIUM/NEMA UD2.
Electrical Safety & Essential PerformanceLeakage current, dielectric strength, alarms and home use. IEC 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-8, IEC 60601-1-11.
Endoscope TestingSafety of endoscopic equipment (IEC 60601-2-18) and optical performance to the ISO 8600 series.
Usability & Human FactorsUsability engineering evaluation of medical electrical equipment. IEC 60601-1-6.
Physiotherapy & HITU EquipmentUltrasonic physiotherapy and high intensity therapeutic ultrasound. IEC 60601-2-5, IEC 60601-2-62.
Infant IncubatorsInfant and transport incubators. IEC 60601-2-19, IEC 60601-2-20.
Accredited where it matters
Sigma is an ASCA-accredited testing laboratory recognized by the FDA and accredited by A2LA to ISO/IEC 17025:2017. When testing falls within our ASCA scope, you receive an ASCA summary test report for your premarket submission.
View our scope of accreditation →TL-114
FDA ASCA laboratory
4896.01
A2LA ISO/IEC 17025
11
standards in ASCA scope
24 h
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(305) 239-4441 info@sigmascientific.us 490 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33325