TÜV SÜD America takes a step forward in medical equipment certification
TÜV SÜD, one of the leading notified bodies for medical devices, has expanded the scope of its testing facility in Peabody, MA 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 recognition under the IECEE's CB scheme for this location.
"We are excited to be able to provide medical device manufacturers with the facility to test their high-frequency surgical equipment products in the same facility where we operate our world-renowned notified body services" said Adam Menzies, Director of Medical and Health Services for TÜV SÜD America. "This investment reaffirms our commitment to the Boston area, and we look forward to continuing on our path to improve our service offering in this and other key markets in North America."
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.
About TÜV SÜD:
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.