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.
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.
- IEC 60601-2-62: Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
We also carry out measurements to the following standards:
- IEC 62255: Ultrasonics - Power measurement - High intensity therapeutic ultrasound (HITU) transducers and systems
- IEC/TS 62556: Ultrasonics - Field characterization - Specification and measurement of field parameters for high intensity therapeutic ultrasound (HITU) transducers and systems
- IEC 61846 Ed. 1.0. Ultrasonics – Pressure pulse lithotripters – Characteristics of fields. 1998.
- IEC 62359 Ultrasonics Ed. 2.0. Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields. 2010.
- 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.
- EN45502-1 Section 22.1: Active implantable medical devices. 1998
- ISO14708 1: 2014 - 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 and calibration service that ensures your measurement instrument is operating as it should. For Onda hydrophones, we ask that you complete a questionnaire as a starting point and return it to us for review. Upon receiving the device, we will evaluate it and share the results with you. If it is found to not be operating properly, we will consult with you on your options. We recommend that hydrophones be re-calibrated annually. We can often calibrate hydrophones produced by other manufacturers as well. Please contact us for further details.
Similarly, your RFB and PCS device can be evaluated. If the device is in good condition we proceed to calibrate and certify the device is operating normally. We recommend the PCS-1000 be re-calibrated annually and the RFB-2000™ be re-calibrated once every two years.
For more details about returns and evaluations, please see our warranty policy.
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