IEC 60601-1-2
DEKRA Product Testing

Demonstrate worldwide compliance with applicable requirements?

Certification against IEC 60601-1-2

The EMC standard for electrical medical devices

The IEC 60601-1-2 standard is part of a series of standards that fall under IEC 60601​. These internationally recognised standards apply to electrical medical devices. Certification against them make it easier for you to do business in international markets. IEC 60601-1-2 focuses on the electromagnetic compatibility (EMC) of electrical medical devices. If you manufacture electrical medical devices, the experts at DEKRA can test and certify them against this standard. This shows (potential) customers all around the world that your product meets the very highest standards and brings international markets within hand’s reach.

IEC 60601-1-2 requirements

Electromagnetic compatibility is defined as follows in IEC 60601-1-2:
“The ability of ME equipment or an ME system to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment.”

Version 4.1

The latest version of the standard was released in September 2020: IEC 60601-1-2 4.1. In the United States, the transition period from version 4.0 to 4.1 will end on 18 December 2023. No official transition period has been announced for Europe. The new version of this standard was prompted by a number of reasons, including new technological advances. There has been a huge increase in the number of devices that transmit RF (radio frequency) signals, via wifi, Bluetooth, 5G or LTE, etc. This enables devices to link up to each other much easier, because of which immunity requirements have been increased for a number of types of devices.

DEKRA for certification against IEC 60601-1-2 

  • Gain easier and faster access to international markets with a DEKRA certification.  
  • Our experts have all the knowledge and skills necessary to test and certify your electrical medical devices.
  • Combine IEC 60601-1-2 with other certifications.
  • Our experts are active in various international advisory bodies and standardisation committees.  
If you would like to know more about our IEC 60601-1-2 certification service, either request a quote or contact our experts.