SRPS EN IEC 80601-2-78:2020

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

Scope

IEC 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)),

• diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and

• personal care ROBOTS (use ISO 13482).