ISO 80601-2-78:2019

Alcance

Replacement:This part of IEC 80601 applies to the general requirements for BASIC SAFETY and ESSENTIALPERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT tosupport or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to thePATIENT’S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or toME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not thecase, 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).