Element Materials Technology is the perfect partner for EMC testing and global approvals of your electronic medical device.
We work with manufacturers of electrical medical devices from the conception of their products with our medical regulatory affair experts, who identify the appropriate EMC testing standards for your electronic medical products. This helps to remove both the cost and risk from medical product verification and validation during the formal testing phase.
Element is UKAS accredited to BS EN ISO/IEC 17025:2005 and compliant to the medical EMC standard EN60601-1-2 and to ISO 9001:2008. We are a National Certification Body (NCB), a Certification Body Test Laboratory (CBTL) under the IECEE’s Worldwide System for Conformity Testing and Certification of Electronic Equipment and Components and our commercial EMC test reports are accepted universally by Notified Bodies.
EN60601-1-2 specifies the emissions and immunity tests that need to be carried out on a medical product. We can assist you by providing the following test requirements of the standard:
- Mains harmonic emissions
- Conducted RF emissions
- Radiated immunity
- Conducted RF and transient type immunity