Intertek, a testing, inspection, and certification company providing quality and safety solutions across a wide range of industries, provides electromagnetic compatibility (EMC) testing services for medical devices in line with IEC 60601-1-2, including the 4th Edition Amendment 1 requirements.
The company supports testing across the product development cycle, from initial design and prototype evaluation to pre-compliance and full-compliance testing. Its EMC chambers are used to evaluate medical devices against requirements within the EMC Directive, including IEC 60601-1-2 and IEC 60601-2-x particular standards. Intertek operates 3-,5-, and 10-meter chambers across its EMC network.
The IEC 60601-1-2 4.1 standard for medical devices was published in September 2020. A transition period allows the use of Edition 4.0, after which devices are required to meet Amendment 1 (4.1).
Intertek offers EMC pre-compliance scans to diagnose and address issues during the design cycle using its EMC/EMI diagnostic tool EMxpert. These scans enable identification of problem frequencies, sources, and physical locations. The company also conducts radiated emissions and radiated immunity testing to measure unintentional emissions and determine compliance with specified limits.
In addition, Intertek provides electrostatic discharge (ESD) testing to simulate electrostatic impacts during operation. The testing determines compliance with IEC 61000-4-2 and supports identification of ESD-reducing measures for manufacturers.
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