DANSK DSF/FPREN IEC 80601-2-78 PDF

This International Standard applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT’S MOVEMENT FUNCTIONS following an IMPAIRMENT. 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 series) • Diagnostic imaging equipment (e.g. MRI, use: IEC 60601-2-33) • Personal care robots (use: ISO 13482)