TÜV SÜD, one of the leading notified bodies for medical devices, has expanded the scope of its testing facility in New Brighton, MN to include testing of high frequency surgical equipment according to the recognized international standard IEC 60601-2-2:2017. The standard is now formally included in the scope of certification under the IECEE’s CB scheme for this location.
“We are delighted that our New Brighton location is now recognized under the CB scheme as being competent to perform safety testing on high-frequency surgical equipment.” said Adam Menzies, Director of Medical and Health Services for TÜV SÜD America. “This adds to the existing suite of services available in our state-of-the-art facility which already houses a 10-meter EMC chamber. We are committed to continued investment in services and competencies to benefit our medical device clients in the Twin Cities and beyond, and we look forward to announcing further expansions in the coming months.”
The 60601-2-2 standard is recognized by the FDA and international medical device regulators as a consensus standard for devices such as coagulators, ablators, endoscopes and other surgical devices which use high-frequency motion. The IECEE CB Scheme is an international system for mutual acceptance of test reports and certificates dealing with the safety of electrical and electronic components, equipment and products.
Vice President of Marketing
TÜV SÜD America Inc.
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Founded in 1866 as a steam boiler inspection association, the TÜV SÜD Group has evolved into a global enterprise. More than 24,000 employees work at over 1,000 locations in about 50 countries to continually improve technology, systems and expertise. They contribute significantly to making technical innovations such as Industry 4.0, autonomous driving and renewable energy safe and reliable.
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