EN IEC 80601-2-78:2020
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Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
04-03-2020
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).
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