Acoustic Measurement Services

Sonora Medical Systems provides a complete suite of ISO 9001/2000 certified ultrasound measurement services through its Sonic Technologies Laboratory Services Group in Longmont, Colorado. Our Group has over 15 years experience in performing acoustic measurements and has been continuously involved in international standards development for ultrasound equipment.

All measurements are performed using a dedicated computerized acoustic output acquisition system specifically designed to rapidly and reliably measure ultrasound devices according to FDA 510(k) and other international standard requirements. Our reports are accurate, complete, timely and competitively priced. Our facilities are secure, preventing unwanted disclosure of your device's technology before market release. We also maintain complete measurement documentation for future reference. All work is traceable to National Standards Laboratories. We provide these services and other transducer measurement services, including Doppler sensitivity analysis, on a contract basis to clients worldwide. Sonora is a member of the National Electrical Manufacturers Association (NEMA) Ultrasound Division.

We regularly perform measurements in support of the following national and international standards:

• U.S. Food and Drug Administration's (FDA) "510(k)" Guide for Measuring and Reporting the Acoustic Output of Diagnostic Ultrasound Medical Devices"
• AIUM/NEMA UD-2 "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment"
• AIUM/NEMA UD-3 "Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment" (FDA Track III)
• International Electrotechnical Commission (IEC) IEC-60601-2-37 Medical Electrical Equipment - Part 2-37 Particular requirements for safety of ultrasonic medical diagnostic and monitoring equipment
• IEC-61847 "Ultrasonics - Surgical Systems - Measurements and Declaration of the Basic Output Characteristics"
• IEC-60601-2-5 "Medical Electrical Equipment - Part 2-5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment"
• IEC-61846 "Ultrasonics - Pressure Pulse Lithotripters - Characteristics of Fields"
• ISO 14708-1 Implants for Surgery

 
Home :: Ultrasound - Transducers - Systems - FirstCall Testing - The Nickel - Training :: MRI - Parts - Repair - Training :: Test Instruments - Acoustic Measurement - Hydrophones - System - Software - FirstCall Testing - The Nickel :: eStore :: News and Offers - Press Releases - Publications and White Papers - Employment - Special Offers - Tradeshows :: About Us - Contact Information - Driving Directions - Executive Team - Distribution Partners - Request Form
© 2005 SONORA MEDICAL SYSTEMS, INC.