Measurement Services
Onda Corporation has extensive capability for supporting regulatory, exploratory, and certification measurement needs. These testing services are available under strict confidentiality and are traceable to national laboratories. Our test facilities include our in-house OptiSon® Analyzer, a 3-axis scanning system, calibrated hydrophones, laser vibrometers, and a full compliment of all necessary electronic equipment.
Regulatory Measurements
We provide general guidance, reporting, and measurements services for regulatory measurements in accordance with the IEC 60601 series standards. Specifically,
- IEC 60601-2-5 Ed. 3.0. Medical Electrical Equipment – Part 2-5: Particular requirements for the safety of ultrasonic physiotherapy equipment. 2009.
- IEC 60601-2-36 Ed. 1.0. Medical Electrical Equipment – Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy. 1997.
- IEC 60601-2-37 Ed. 2.0. Medical Electrical Equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment. 2007.
We also carry out measurements to the following standards:
- IEC 61846 Ed. 1.0. Ultrasonics – Pressure pulse lithotripters – Characteristics of fields. 1998.
- IEC 62359 Ultrasonics Ed. 1.0. Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields. 2006.
- IEC 61689 Ed. 2.0 Ultrasonics – Physiotherapy systems – Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz. 2007.
- IEC 61847 Ed. 1.0 Ultrasonics – Surgical Systems - Measurement and declaration of the basic output characteristics. 1998.
- IEC 61205 Ed. 1.0. Ultrasonics - Dental Scalers Systems – Measurement and declaration of output characteristics. 1993
- EN45502-1 Section 22.1: Active implantable medical devices. 1998
- ISO14708 1:2000 - Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer.
- AIUM NEMA UD3 Standard for real time display of thermal and mechanical acoustic output indices on diagnostic ultrasound equipment. 2004 – Revision 2
- AIUM NEMA UD2 Acoustic output measurement standard for diagnostic ultrasound equipment. 2007
Drop-in Measurement Services
Onda Corporation also provides the opportunity for our customers to make exploratory measurements at our facility in California. By pre-arrangement, customers may bring their equipment, observe and guide measurements at Onda Corporation. All measurements are performed at our facility by PhD-level staff. Please contact us for details.
Evaluation, Re-calibration and Re-certification Services
We offer a certification service that ensures your measurement instrument is operating as it should. For Onda hydrophones, RFB’s, and PCS’s, we will evaluate your device at no charge and share the results with you. If it is not in good condition, we will contact you to consult on your options. Typically, either the device is repaired or a replacement hydrophone is purchased. Please contact us to learn about our trade-in policy. If the device is in good condition we proceed to calibrate and certify the device is operating normally. For more details about returns and evaluations, please see our warranty policy.
Similarly, Onda can often calibrate hydrophones produced by other manufacturers. Please contact us for further details.
We recommend that hydrophones and the PCS-1000 are recalibrated annually and that the RFB-2000™ is calibrated once every two years.