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

Abstract

EC 80601-2-78:2019 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.IEC 80601-2-78:2019 does not apply to• external limb prosthetic devices (use ISO 22523),• electric wheelchairs (use ISO 7176 (all parts)),

General Information

ICT rolling plan topic: Robotics

SDO: IEC

Latest publishied version: https://webstore.iec.ch/publication/33594