Miamind® Neurostimulator Achieves Official Certification from DEKRA | Bottneuro

Miamind® Neurostimulator Achieves Official Certification from DEKRA

Posted on 01 September, 2023

Bottneuro has received official confirmation from DEKRA that the Miamind® Neurostimulator has successfully passed all relevant external device tests, ensuring its compliance with essential international standards. This achievement solidifies Bottneuro AG's commitment to delivering cutting-edge solutions that meet the highest quality and safety standards. The Miamind® Neurostimulator has passed the following certifications:

IEC 60601-1 for General Medical Equipment: This certification attests that the Miamind® Neurostimulator complies with the fundamental safety and performance standards required for general medical equipment. It reflects Bottneuro AG's dedication to ensuring the utmost safety for patients and healthcare professionals.

IEC 60601-1-11 for Home Use: The Miamind® Neurostimulator's successful completion of IEC 60601-1-11 demonstrates its suitability of medical electrical systems for home use, emphasizing its versatility and accessibility for a wide range of patients. This recognition paves the way for improved patient care in the comfort of their homes.

IEC 80601-2-26 for EEG Performance: With this certification, the Miamind® Neurostimulator showcases its safety and essential performance of electroencephalographs. This achievement highlights its potential to contribute significantly to neuroscientific research, diagnosis, and treatment.

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