Measurements
The numbers behind your test report. We measure acoustic, electrical, thermal, optical and material properties of medical devices with calibrated instruments, and report every result with its uncertainty.
- Acoustic
- Electrical
- Thermal
- Optical
- Materials
Measurement explorer
What we measure
Twelve measurements behind our test reports, with the accreditation that covers each one.
Acoustic power
Total ultrasonic output power of diagnostic, physiotherapy and HITU transducers, measured with a radiation force balance.
IEC 61689 · IEC 60601-2-5 · IEC 60601-2-62Pressure and intensity
Hydrophone scans of the acoustic field: peak pressures, spatial-peak intensities, mechanical and thermal indices (MI, TI).
IEC 62127-1 · IEC 62359 · AIUM/NEMA UD 2 · IEC 60601-2-37Temperature increase
Surface temperature of transducers and applied parts, in simulated use and in still air, against the limits of the standard.
IEC 60601-2-37 · IEC 60601-1Leakage current
Earth, touch and patient leakage currents in normal and single fault condition, including applied parts and endotherapy accessories.
IEC 60601-1 · ANSI/AAMI ES60601-1 · IEC 60601-2-18Dielectric strength
Insulation withstand between parts at the test voltages set by the standard, with breakdown and flashover monitoring.
IEC 60601-1 · ANSI/AAMI ES60601-1Alarm sound level
Sound pressure level, pulse timing and frequency content of medical alarm signals by priority.
IEC 60601-1-8Ultrasound image quality
Resolution, penetration depth and dead zone of pulse-echo diagnostic systems, measured on calibrated phantoms.
JIS T 1501Field of view
Field of view and direction of view of endoscopes with optics, and maximum width of the insertion portion.
ISO 8600-3 · ISO 8600-4Optical resolution
Optical resolution of rigid endoscopes, plus noise and spatial frequency response of electronic imaging.
ISO 8600-5 · ISO 15739 · ISO 12233Incubator temperature
Temperature uniformity, overshoot and stability of infant and transport incubators over long test runs.
IEC 60601-2-19 · IEC 60601-2-20Speed of sound
Speed of sound, attenuation and acoustic impedance of ultrasound gels and coupling materials.
Sigma method EIR-013Viscosity and pH
Viscosity, pH and density of ultrasound gels, for formulation control and product claims.
Sigma method EIR-013Range
From microamps to megapascals
One laboratory for the physical quantities your device has to prove: acoustic, electrical, thermal, optical and material.
How we measure
A number you can defend
FAQ
Measurement questions
Can you measure outside a standard, with our own protocol?
Yes. We develop custom test protocols for engineering and verification, run with the same calibrated instruments as our accredited work.
Do your reports include measurement uncertainty?
Yes. Each accredited result is reported with its measurement uncertainty, so reviewers can judge it against the limit.
What is the difference between FDA ASCA and A2LA?
FDA ASCA covers 11 standards that the FDA accepts through the ASCA program. Our A2LA ISO/IEC 17025 scope is wider and includes optical, imaging and acoustic methods. See our accreditations.
Can you measure a single parameter without a full test program?
Yes. Many clients order a single measurement, such as acoustic power or leakage current, during design or after a change.
Request a measurement 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