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

Replacement: 
This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIAL 
PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to 
support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the 
PATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER. 

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to 
ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the 
case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. 

NOTE See also 4.2 of the general standard. 

This particular standard does not apply to 
• external limb prosthetic devices (use ISO 22523), 
• electric wheelchairs (use ISO 7176 (all parts)), 
• diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and 
• personal care ROBOTS (use ISO 13482).