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Publication details

Publication CODE Title
IEC 80601-2-78:2019+AMD1:2024 CSV (2024-03) MEDICAL ELECTRICAL EQUIPMENT - PART 2-78: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL ROBOTS FOR REHABILITATION, ASSESSMENT, COMPENSATION OR ALLEVIATION
 
Price Excl. VAT Total number of pages, tables and drawings
848.00 € 330.
Description
IEC 80601-2-78:2019+AMD1:2024 CSV 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).
Class  C990  (IEC PUBLICATIONS IEC PUBLICATIONS)
Available files
EN/FR version

Status
Status IEC PUBLICATION
Situation Currently active
Origin
Committee TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
Responsible De heer VAN HECKE Luk
Approval
BEC Approval 2024-03-12
ICS-Code (International Standards Classification) 11.040.01
NBN Status New
IEC publication date 2024-03-12
IEC stability date 2028-12-31
IEC file modification date 2024-03-12
IEC last modification date 2024-03-12