Physiotherapy Systems
Ultrasonic Field Characterization
Testing Services
Sigma offers ultrasonic field characterization of medical devices. Testing is aimed to evaluate compliance with acoustic intensity levels as per relevant test standards and regulatory requirements. These are required to ensure that physiotherapy devices are safe and effective for their intended use. Sigma Scientific is an ISO/IEC 17025 and FDA accredited medical device safety and performance test laboratory to perform electrical safety testing of medical products.
Test Methods
Test methods include the IEC 63045 Ultrasonics – Non-focusing short pressure pulse sources including ballistic pressure pulse sources – Characteristics of fields, IEC 61846 Ultrasonics –Pressure pulse lithotripters –Characteristics of fields, IEC 61689-1 Ultrasonics – Physiotherapy systems – Field specifications and methods of measurement in the frequency range 0,5 MHz to 5 MHz, IEC 60601-2-5 Medical electrical equipment – Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment, and IEC 60601-2-62 Medical electrical equipment – Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HIFU) equipment.
Test Reporting
Measurements and test reports include, among others:
Temperature increase
Displacement and penetration
Energy density
Beam cross sectional area ABCS
Beam profiles
Acoustic power and intensity
Energy density
Accuracy of display and controls
Unwanted ultrasound radiation
Excessive ultrasound radiation
Effective radiation area ERA
Beam non-uniformity ratio BNR