Electrical Medical Device Testing
IEC 60601 is the international standard for the safety and performance requirements for electrical medical devices. Find out, through DEKRA's expertise in testing and certification, how you can ensure the safety of your medical electrical equipment.
How do we test your electrical medical devices?
- As an RvA approved testing laboratory;
- Via IEC schemes as a certified body test lab (CBTL);
- By offering a large scope including Electromagnetic Compatibility (EMC) and Radio Equipment (RED).
For our Notified Body services in accordance to the Medical Device Regulation (MDR), please click here.
Why test your electrical medical devices?
Electrical Medical Devices need to be safe for both users and patients. Complying to the applicable standards assures that your product is widely accepted to be safe.
Complying to the essential performance standards achieves freedom from unacceptable risk.
Complying to the standards from an early stage in your research and development process prevents costly redesigns and even more costly market withdrawals. DEKRA provides guidance for a First Time Right.
Testing against harmonized standards provides easier access to markets around the world. As a global partner for safety, we are involved in international recognition procedures, such as INMETRO and NRTL approvals.
6 reasons to choose DEKRA for testing your medical devices
1. Extensive scope
Our scope includes most safety standards for the ISO 17025 as well as for CB certification. DEKRA also carries out conformity assessment in accordance with IEC 62304 (software life cycle), IEC 60601-1-6 / IEC 62366 (usability) and ISO 14971 (risk management). If needed we can discuss a scope extension based on a long-term partnership.
2. Short Time to Market
Our facility and experience in this field speaks for itself. You are in good hands. As a manufacturer or designer you know your product best. We know the standards, have professional test facilities as well as experienced and qualified engineers to certify your products. This provides all the ingredients for a reliable, and fast track to market. After all, time is of the essence.
3. EMC & Wireless test labs
We have a well-equipped lab with comprehensive EMC & Wireless testing capabilities including 60601-1-2 for Medical Equipment, the Directives for Low Voltage and the RED. All from the convenience of our facilities located in Arnhem, The Netherlands.
4. Expert guidance
Together with the manufacturer, DEKRA identifies the applicable standards and provides testing and certification for (complex) Electrical Medical Devices. Our engineers are here to help you in this often complex process, via a pre-complaince check or engineering review.
5. Technical documentation
The DEKRA scope includes IEC 62304 (software life-cycle), IEC 60601-1-6 / IEC 62366 (usability) and ISO 14971 (risk management).
6. Certified Body Accredited Test Laboratory (CBTL)
We are an accredited test laboratory (CBTL) testing according to the CB scheme of the IEC standards.
Do you have a question? Get in touch with one of our experts
