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
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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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Tool · Standards finder
Which standards apply to your device?
Pick your device type, answer four quick questions and get the standards Sigma can test it to, with the accreditation behind each one.
- 10 device types
- 23 standards and methods
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1 Device type
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This finder is guidance based on Sigma’s accreditation scope. The final list depends on your device’s intended use, claims and risk management file.
Not sure about your list? Consult with a medical device test expert.
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