IEC 80601-2-78:2019
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Ausgabedatum:
2019-07
Edition:
1.0
Sprache: EN-FR - zweisprachig englisch/französisch
Seitenzahl: 156 VDE-Artnr.: 247815
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).
