Medical images on a tablet PC

EMC medical technology

EMC medical technology
– tests & measurements

The professional testing of electromagnetic compatibility is particularly important and mandatory for electrical devices in medicine. The requirements for electromagnetic interference are strict, especially in the medical environment, and the results of the EMC tests must provide a reliable basis for eliminating the interference.

EMC tests for medical technology

Our EMC laboratories in Saarbrücken and Essen are accredited by the German Accreditation Body (DAkkS), including the Central Office of the Federal States for Health Protection for Drugs and Medical Devices (ZLG), to carry out EMC tests for technical medical devices. We offer EMC testing services for electrical medical devices in accordance with various guidelines and requirements:

  • Medical Devices Directive (93/42/EEC / 2007/42/EC)
  • Medical Directive 2017/745 (MDR) and 2017/746 (IVDR)
  • Guideline EN/IEC 60601-1-2, 4th edition
  • Directive EN/IEC 60118-13
  • Directive EN/IEC 61326-2-6

Our testing services related to products

In addition to our EMC tests on medical technology products, we also offer additional services in our laboratories. In the area of electrical safety, for example, we carry out a variety of tests for medical devices based on a wide range of standards:

  • EN/IEC 60601-1 / -8 / -11
  • EN/IEC 61010-2-66 including the required technical documentation as risk management (ISO 14791),
    usability (EN/IEC 60601-1-6) and software documentation (EN 62304)
  • EN/IEC 61010-1
  • EN/IEC 61010-2-040 / -081 / -101
  • IEC 61010-031

We are also an accredited laboratory for CB tests in the areas of electrical safety and EMC. In this function we can carry out measurements for hearing aids:

  • Electroacoustic measurements of hearing aids for the North American and European markets
  • Coexistence testing for FDA
  • Environmental testing
    • Vibration, shock, climate, IP classification
  • Battery tests

Our laboratories are constantly adapted to current technical requirements and we therefore guarantee accurate results in a professional and technically high-quality environment.