COFRAC accreditation for SGS’s ultrasound measurement laboratory in Aix en Provence



COFRAC accreditation for SGS’s ultrasound measurement laboratory in Aix en Provence
GENEVA, 12-Feb-2019 — /EuropaWire/ — The French Accreditation Committee (COFRAC) has just accredited SGS’s ultrasound measurement laboratory in Aix en Provence. In fact, it is even the first lab of this type in France to gain accreditation by COFRAC.
Accreditation comes as a guarantee for SGS’s capability to evaluate products for compliance with national regulations and international standards in every major medical device market.
The purpose of SGS’s ultrasound measurement lab is to measure the acoustic output of the ultrasound systems. It relies on 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.
Furthermore, the laboratory has also in place an ultrasound power meter meant to measure the ultrasound power output of diagnostic or therapeutic transducers up to 30 watts.
The team that runs SGS’s laboratory in Aix en Provence is very experienced in the field of ultrasound measurements, electromedical equipment safety and regulatory affairs.
In general, IEC standards for electromedical equipment do require ultrasound measurements and testing can only be done with specific and accurate test equipment and conducted by specialized and accredited laboratories.
International IEC standards govern the medical equipment that use ultrasound for diagnostic or therapeutic applications and are as follows: IEC 62127-1 for Ultrasound Field Measurement, IEC 60601-2-5 for Ultrasound Therapy Equipment, IEC 60601-2-37 for Ultrasound Diagnostic Equipment and IEC 60601-2-62 for HIFU Equipment.
Additionally, the standard ISO 14708-1 covers and defines the specific requirements for testing of active implantable medical devices for immunity against ultrasonic exposure with the aim of characterization and measurement of ultrasound fields emitted by the transducers.
SGS’s ISO/IEC 17025:2005 accredited lab covers the testing requirements of over 53 countries around the world providing all the tests and measurements required for compliance to the standards IEC 60601-1 and the CB scheme.
SOURCE: SGS
MORE ON MEDICAL DEVICE, ULTRASOUND SYSTEMS, SGS:

YIT to start construction on the second stage of Hollister Incorporated’s medical device factory in Kaunas, Lithuania – YIT has signed a contract with Hollister Incorporated, a US-based medical products manufacturing company, to construct the second stage of a medical device factory in Kaunas, Lithuania…

Delta Electronics’ high voltage generator for X-ray equipment received medical device certification by TÜV Rheinland – Achieving compliance with the European Union (EU) MDD 93/42/EEC medical devices directive, and receiving EN ISO 13485 medical quality management system certification is an industry milestone that makes Delta the first power-supply manufacturer in Taiwan capable of manufacturing medical-grade high-voltage generators for X-ray equipment…

Royal Philips to acquire US-based medical device company Electrical Geodesics, Inc. – EGI’s portfolio of EEG hardware, software and acquisition sensors will complement Philips’ existing portfolio of imaging technologies (e.g. MRI and PET-CT) and advanced informatics…

Toshiba Medical Systems Europe launches the Innovation 2016 upgrade for the Aplio Platinum line of ultrasound systems – Assembled as a toolkit for clinicians, Innovation 2016 upgrade brings new capabilities to radiologists using the Aplio Platinum line in everyday practices, including 3D Superb Micro-Vascular Imaging (SMI), 3D Shear Wave Elastography, Fusion Imaging and Real-Time 3D Needle Tracking…

Industry-first integrated tele-ultrasound solution based on Philips’ Lumify portable ultrasound system and powered by IIT’s Reacts collaborative platform – This innovation connects clinicians around the globe in real time by turning a compatible smart device into an integrated tele-ultrasound solution, combining two-way audio-visual calls with live ultrasound streaming…

Philips will showcase its wide portfolio of OB/GYN ultrasound tools at 27th World Congress on Ultrasound in Obstetrics and Gynecology (ISUOG) – Showcased at the 27th World Congress on Ultrasound in Obstetrics and Gynecology (ISUOG), Philips’ OB/GYN ultrasound solutions are designed to give clinicians more information earlier in pregnancy, making it easier to provide a confident diagnosis and overcome diagnostic challenges…

SGS: European Union to regulate 33 carcinogenic, mutagenic or reprotoxic (CMR) category 1A or 1B substances under new entry 72 to Annex XVII of REACH – The European Commission has published a guideline with methods to assist the industry to comply with CMRs under entry 72 to Annex XVII of REACH. The stricter limits apply for different concentration limits in other entries to Annex XVII of REACH or EU legislation…

SGS ready to provide testing and/or certification services in accordance with ANSI/CAN/UL-2743 (2nd Ed) for the North American Market – With lead-acid or lithium battery energy storage technology portable power packs are becoming more popular with consumers, thanks to their convenience for outdoor use. Typical products include not only portable energy storage…

SGS Digicomply paves the way for future intelligent compliance management systems – Deep Learning algorithms, combined with the human expertise of SGS, are significantly improving outcomes for our customers…

SGS to expand its biopharmaceutical testing capabilities in Geneva with a new 200m2 laboratory – The laboratory will be equipped with a number of state-of-the-art instruments, to respond to the growing need for biopharmaceutical studies during the early and late phase of characterization, as required by the ICH guidelines…

Fraunhofer Institute researchers developed X-ray detector for industrial computed tomography (CT) based on the design of medical X-ray devices – In medicine, X-rays provide high-resolution images of our insides to help doctors make a definitive diagnosis. Industry uses X-rays, too – as a reliable, non-destructive way of seeing what’s hidden on inside materials and components and to check for cracks or irregularities…

More news stories and press releases on medical device…
More news stories and press releases on ultrasound systems…
More news stories and press releases on SGS…