SGS welcomes the accreditation which is a guarantee of its capability to evaluate products for compliance with international standards and national regulations in every major medical device market.
Ultrasound measurements, required by IEC standards for electromedical equipment, can only be performed by specialized laboratories, using very specific and accurate test equipment. The specialized laboratory at Aix en Provence is driven by a team experienced in the domain of ultrasound measurements, electromedical equipment safety and regulatory affairs.
Medical equipment using ultrasound for diagnostic or therapeutic applications is managed by several international IEC standards, depending on the intended use of the equipment. These standards are:
- IEC 62127-1 (Ultrasound Field Measurement)
- IEC 60601-2-5 (Ultrasound Therapy Equipment)
- IEC 60601-2-37 (Ultrasound Diagnostic Equipment)
- IEC 60601-2-62 (HIFU Equipment)
In addition, active implantable medical devices need to be tested for immunity against ultrasonic exposure. Requirements for this test are defined in the standard ISO 14708-1. One common and major requirement of these standards is the characterization and measurement of ultrasound fields emitted by the transducers.
SGS has developed its ultrasound measurement laboratory to measure the acoustic output of the ultrasound systems. This uses a three-axis table composed of a precision scanning system, high performance wideband PVDF needle and membrane hydrophones suitable for a large frequency bandwidth ranging from 25KHz to 30MHz.
The laboratory is also equipped with an ultrasound power meter designed to measure the ultrasound power output of diagnostic or therapeutic transducers up to 30 watts.
In addition, SGS's ISO/IEC 17025:2005 accredited lab provides all the tests and measurements required for compliance to the standards IEC 60601-1 and the CB scheme that covers testing requirements of over 53 countries.
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SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.