IEC 80601-2-78:2019 ED1


Note: Latest version: IEC 80601-2-78:2019+AMD1:2024 CSV

Existing or new amendments and versions must be purchased separately.



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).

Products specifications

  • Standard from IEC
  • Published:
  • Edition: 1
  • Document type: IS
  • Pages
  • Publisher: IEC
  • Distributor: IEC
  • ICS: 11.040.01
  • International TC: TC 62/SC 62D