SGS becomes first COFRAC accredited ultrasound measurement laboratory in France
Ultrasound measurement laboratory, developed by SGS at Aix en Provence, becomes the first laboratory in France accredited by COFRAC for the measurement of ultrasound fields for electromedical equipment and for active implantable medical devices.
- (1888PressRelease) February 14, 2019 - SGS, the world’s leading inspection, verification, testing and certification company, has established the first laboratory in France to gain accreditation by COFRAC, the French Accreditation Committee, for the measurement of ultrasound fields for electromedical equipment.
The specialized laboratory at Aix en Provence provides a global solution for the testing and certification of ultrasound fields measurements for electromedical equipment as required by IEC standards. It is driven by a team experienced in the domain of ultrasound measurements, electromedical equipment safety and regulatory affairs.
Souheil Mansour, Medical Devices Strategic Expert, SGS said: “We are delighted to receive this accreditation from COFRAC which guarantees the world-class standard of our laboratory to deliver a complete range of specialist testing, certification and auditing services. As the first lab to receive this endorsement in France, we look forward to working with manufacturers to evaluate products for compliance with international standards and national regulations in every major medical device market.”
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.
At Aix en Provence, SGS has developed an 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.
For more information, please contact:
Souheil Mansour, PhD
SGS France
Medical Devices Strategic Expert
Email: sgs.crs ( @ ) sgs dot com
Website: www.sgs.com/ee
ABOUT SGS
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.
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