Consolidated

IEC 80601-2-78:2019+AMD1:2024 CSV

Current

Existing or new amendments and versions must be purchased separately.

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Abstract

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).

Products specifications

  • Consolidated from IEC
  • Published:
  • Edition: 1.1
  • Document type: IS
  • Pages
  • Publisher: IEC
  • Distributor: IEC
  • ICS: 11.040.01
  • International TC: TC 62/SC 62D