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
Circulation Date:
2019-07
Edition:
1.0
Language: EN-FR - bilingual english/french
Seitenzahl: 156 VDE Artno.: 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 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).