IEC 80601-2-78:2019 Preview
Medical electrical equipment -- Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
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 PATIENTS 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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