IEC 60601 certification
DEKRA Product Testing

Does your medical equipment comply with the latest IEC 60601 laws and regulations?

IEC 60601 certification

Testing of electrical medical equipment

IEC 60601 is the international standard for safety and performance requirements for electrical medical equipment. IEC stands for the International Electrotechnical Commission. Compliance testing with the IEC 60601 standard is part of the process for the Medical Device Regulation (MDR).

Due to the increasing complexity of electrical medical devices, testing and certification according to the IEC 60601 standard is essential. Electrical medical devices (active devices) are defined as any type of electrical equipment that determines the level of energy transfer to or from the patient. The IEC/EN 60601 is a widely accepted series of standards; equipment that does not comply with the standard may pose a risk to patients.
The best way to demonstrate compliance with the applicable IEC 60601 standard is to collaborate with an accredited test laboratory that can provide detailed and relevant reporting as input for the technical documentation for your device. Below is an overview of the most relevant parts of the IEC 60601 standard for electrical medical equipment:
Product safety
For Class I devices, a self-declaration is sufficient to obtain the CE marking (required to sell your product within the EU). Evidence of compliance with relevant standards (such as the EN 60601 safety standards) should still be part of your technical documentation.
For Class II devices, there are higher risks. Therefore, a Notified Body must assess the compliance of your product with the Medical Device Regulation (MDR) based on your technical documentation. This requires the inclusion of reports and certifications relevant to the applicable standards for your electrical medical equipment.
Usability
Electro Magnetic Compatibility (EMC)
Radiofrequency
Software and Cybersecurity
Relevant standards and guidance documents
It is the responsibility of the manufacturer to have identified all applicable standards and guidance documents for their medical device. For more details see our IEC standards and CB scope .

DEKRA for your EN 60601 compliance

With DEKRA, you can have your medical equipment tested for compliance with the IEC 60601 standard. Choosing DEKRA provides several benefits:
  • DEKRA offers a wide range of testing and certification services.
  • The test results and certifications from DEKRA are globally accepted.
  • You enhance confidence among stakeholders with independent test results.
  • DEKRA can also test your medical equipment as a Notified Body.

IEC 60601 certification Version 3.2

The third edition of IEC 60601-1 was published in 2005 and amended in 2012. The fourth edition will be rolled out in 2027 or later. To sell your electrical medical devices until then, you must comply with the second amendment of the third edition. Want to know more about the impact of the amendment to the IEC 60601 standard? Fill in your contact details via the form below, and you will receive our free whitepaper ''Update 60601 version 3.2: what has changed?'' by email.

More about our IEC 60601 services