BOXBOROUGH, Mass.--(BUSINESS WIRE)--Intertek, a leading provider of quality and safety solutions serving a wide range of industries around the world, announced its Boxborough, MA, laboratory is the first lab in North America to receive accreditation to conduct electromagnetic compatibility (EMC) testing to the IEC 60601-1-2 4th Edition standard for medical products by the IECEE. This accreditation allows Intertek to be on the forefront of helping to offer safe medical equipment and medical systems to the industry and consumers on a global level.
As electronic devices continue to become more commonplace in everyday life, medical devices that may be sensitive to EMC output from these devices need to be built to withstand potential interference (immunity). Increases in this immunity was a key update in the new 4th edition of IEC 60601-1-2, as required immunity levels rose in several areas, including the range of testing for radiated immunity (up to 2.7GHz), magnetic immunity (up to 30A/m), and conducted immunity (up to 6V in ISM bands). These changes address increasing global and local EMC levels, helping to ensure the safe creation, development, and operation of medical devices in any location.
Intertek can provide testing to this level of EMC immunity due in part to its expertise in testing to military and aerospace standards, particularly MIL-STD-461F. This standard includes requirements for the control of electromagnetic interference with military-level equipment, and with experience in such testing, Intertek has the benefit of utilizing its large amplifier equipment that is able to emit EMC at the necessary testing levels.
“This is a substantial change in the IEC standard for Medical device EMC testing,” said John Quigley, Vice President of Quality, Intertek. “We had the unique combination of expertise and equipment to gain IECEE accreditation quickly and begin helping our clients get their products to market faster.”
As medical device manufacturers prepare to meet the new requirements for this standard update, Intertek can assist with knowledge and information on how to be prepared for compliance. Intertek’s Boxborough laboratory also recently gained approval from the American Association for Laboratory Accreditation (A2LA) for expanded testing and certification services regarding medical devices, helping to offer a one-stop shop for testing needs in the medical industry.
For more information about Intertek’s services in general, or for particular specs of the new testing capabilities in Boxborough, contact Derek Silva at derek.silva@intertek.com.
About Intertek
Intertek is a leading quality solutions provider to industries worldwide. From auditing and inspection, to testing, training, advisory, quality assurance and certification, Intertek adds value for its customers by helping improve the quality and safety of their products, assets and processes. With a network of more than 1,000 laboratories and offices and over 36,000 people in more than 100 countries, Intertek supports companies’ success in the global marketplace, by helping customers to meet end users’ expectations for safety, sustainability, performance, integrity and desirability in virtually any market worldwide. Visit www.intertek.com