DIN EN IEC 80601-2-78:2025-05

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. In the IEC 60601 series of standards the Particular Requirements may, where applicable, modify, replace, or delete the requirements contained in the General Requirements and the Supplementary Standards for the respective medical electrical equipment, and may add other requirements with regard to basic safety and essential performance. A requirement in the Particular Requirements takes precedence over the General Requirements. These particular requirements do not apply to - external limb prosthetic devices (see ISO 22523); - electric wheelchairs (see ISO 7176 (all parts)); - diagnostic imaging equipment (for example MRI, see IEC 60601-2-33); and - personal care ROBOTS (see ISO 13482); - robots with robotic arms for the lower extremities; - robots with robotic arms for the upper extremities; - robots designed as exoskeletons for the upper extremities; - robots as exoskeletons for the knee joints; - robots as soft artificial muscles for the knee joint; - robots as exoskeletons for the lower extremities; - robots for controlling postural balance; - robots that support body weight and have a gait-following function.