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Sigma Scientific

Acoustic Output Measurement and Diagnostic Ultrasound Testing

Accredited Acoustic Output Measurement for FDA 510(k), IEC 62127-1, IEC 62359 and IEC 60601-2-37

Accredited Acoustic Output Measurement for FDA 510(k), IEC 62127-1, IEC 62359 and IEC 60601-2-37

Sigma Scientific Services provides accredited acoustic output measurement and diagnostic ultrasound testing for manufacturers of medical ultrasound systems and transducers seeking FDA clearance or international regulatory approval. Our ISO/IEC 17025 accredited laboratory performs hydrophone-based acoustic measurements to characterize ultrasound fields, verify safety, and demonstrate compliance with FDA guidance and internationally recognized standards. We support manufacturers throughout the entire product lifecycle, including product development, design verification, regulatory submissions, design modifications, manufacturing validation, and post-market testing. Whether you are preparing a new FDA 510(k), modifying an existing ultrasound system, validating a new transducer, or comparing your device against a predicate, Sigma Scientific provides technically rigorous testing supported by experienced ultrasound engineers and regulatory specialists.

Test Methods

Sigma Scientific performs testing in accordance with internationally recognized standards used for FDA and global regulatory submissions. Our testing supports compliance with:

  • IEC 62127-1 — Ultrasonics – Hydrophones – Measurement and Characterization of Medical Ultrasonic Fields
  • IEC 62359 — Field Characterization and Determination of Thermal and Mechanical Indices
  • IEC 60601-2-37 — Particular Requirements for Ultrasonic Medical Diagnostic Equipment
  • FDA Guidance for Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
  • ISO/IEC 17025 Accredited Testing

Measurements and Test Reporting

Test report include maximum acoustic field variables, statistical and uncertainty analysis, a description of the measurement system, and the description of the measurement process,. Variables include:

  • Acoustic Pressure Waveforms
  • Peak Compressional Pressure
  • Peak Rarefactional Pressure
  • Pulse Intensity Integral (PII)
  • Center Frequency
  • Acoustic Power
  • Spatial Peak Pulse Average Intensity (ISPPA)
  • Spatial Peak Temporal Average Intensity (ISPTA)
  • Pulse Duration
  • Pulse Repetition Frequency
  • Beam Width, Beam Profile and Focal Distance
  • Mechanical Index (MI), Thermal Index (TIS, TIB, TIC)
  • Acoustic Field Mapping, Beam Uniformity
  • Acoustic Exposure Parameters

Ultrasound Testing