IEC 80601-2-78 ED2 Medical electrical equipment - Part 2-78

IEC 80601-2-78 ED2 Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation. 

In the medium term, IEC 80601‑2‑78 Ed.2 will serve as the basis for a corresponding European standard that can be harmonised under the MDR. This will support European SMEs by providing a recognised and authoritative framework for demonstrating conformity. As a result, companies can reduce the time and cost associated with regulatory approval, improve the quality and consistency of their technical documentation, and accelerate their access to the European market