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FDA ASCA accredited · TL-114

Medical Device Testing Services

Accredited testing of medical electrical equipment and ultrasound systems for your FDA submission, plus A2LA accredited endoscope optical testing and ultrasound gel and material testing.

  • FDA ASCA TL-114
  • A2LA 4896.01
  • ISO/IEC 17025
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Not sure which tests you need? Consult with a specialist.

Accredited testing · FDA ASCA · A2LA

Ten accredited services for your submission

Nine services within our FDA ASCA scope, with an ASCA summary test report for your 510(k), plus endoscope optical testing accredited by A2LA.

ASCA · A2LAIEC 60601-2-37 · IEC 62127-1Ultrasound acoustic outputAcoustic output, thermal and mechanical indices of diagnostic ultrasound systems and transducers.View service →ASCA · A2LAIEC 60601-1 · ANSI/AAMI ES60601-1Electrical safetyBasic safety and essential performance of medical electrical equipment, from leakage current to dielectric strength.View service →ASCA · A2LAIEC 60601-1-6 · IEC 62366-1Usability & human factorsEvaluation of your usability engineering process and file, tied to risk management.View service →ASCA · A2LAIEC 60601-2-5 · IEC 61689Physiotherapy ultrasoundOutput power, effective radiating area and beam non-uniformity of every treatment head.View service →ASCA · A2LAIEC 60601-2-18Endoscope safetyLeakage current, insulation and temperature of endoscopes, camera heads and light sources.View service →ASCA · A2LAIEC 60601-2-62High intensity therapeutic ultrasoundAcoustic power and focal field measurements of HITU and HIFU systems.View service →ASCA · A2LAIEC 60601-2-19 · IEC 60601-2-20Infant incubatorsTemperature control, humidity, CO₂, air flow and alarms of infant and transport incubators.View service →ASCA · A2LAIEC 60601-1-8Alarm systemsAlarm priorities, auditory and visual signals, delays and inactivation states.View service →ASCA · A2LAIEC 60601-1-11Home healthcare equipmentEnvironmental conditions, water, drops, cleaning and lay operators in the home.View service →A2LAISO 8600 seriesEndoscope optical performanceField of view, resolution, distortion, color and latency of rigid and flexible endoscopes.View service →

Materials testing

Ultrasound gels and materials

Acoustic and physical properties of ultrasound gels and coupling materials, measured by the team behind our accredited acoustic testing.

MaterialsSpeed of sound · attenuation · viscosityUltrasound gels and probe coversAcoustic and physical properties of coupling gels and probe covers, unaged and aged.View service →

By device

Find the right test for your device

The services manufacturers usually combine for each type of device. We confirm the full list with your quote.

DeviceServices
Diagnostic ultrasound systemsEndoscope optical performanceEndoscope safetyUltrasound acoustic outputElectrical safetyUsability & human factorsPhysiotherapy ultrasoundElectrical safetyHigh intensity therapeutic ultrasoundUltrasound acoustic outputElectrical safety
Patient monitorsAlarm systems · Electrical safety · Usability & human factors
Infusion pumps and home-use devicesHome healthcare equipment · Alarm systems · Usability & human factors
Infant incubatorsInfant incubators · Alarm systems
Coupling gels and probe coversUltrasound gels and probe covers

How it works

From quote to report

One team plans, tests and reports, so nothing gets lost between steps.

01Tell us about your deviceDevice, intended use and the standards you need. We reply with scope, price and timeline within 24 hours.
02Agree on the test planWe map the clauses that apply and tell you which units, accessories and documents to send.
03Testing in our laboratoryYour device is tested by our specialists, and we tell you early if anything fails.
04Report ready to fileClause-by-clause results, with an ASCA summary test report for tests within our ASCA scope.

Accreditation

Accredited where it matters

TL-114FDA ASCA accredited testing laboratory for medical electrical equipment and ultrasound standards.See our FDA listing →
4896.01A2LA accredited to ISO/IEC 17025:2017 for medical electrical equipment and acoustic test methods.Scope of accreditation →
24 hQuote response with scope, price and timeline for your device.Request a quote →

Measurements

Need a single measurement? Explore the 12 quantities we measure.

Acoustic power, leakage current, temperature, optical resolution and more, each with its accreditation.

Explore measurements

FAQ

Frequently asked questions

What is an ASCA accredited laboratory?

ASCA is the FDA program for Accreditation Scheme for Conformity Assessment. Tests run by an ASCA accredited laboratory within its scope come with an ASCA summary test report, which the FDA accepts in your premarket submission.

Which of your services are accredited?

Nine services are within our FDA ASCA scope, and endoscope optical performance is accredited by A2LA (ISO/IEC 17025).

Can you test to a standard that is not listed?

Often, yes. Tell us the standard and your device, and we will tell you whether we can test to it and how it would be reported.

How fast can I get a quote?

Within 24 hours. Tell us the device, its intended use and the standards you need, and we reply with scope, price and timeline.

Request a 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

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