New project
IEC/AWI 80601-2-78
Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Reference number
IEC/AWI 80601-2-78
Edition 2
© ISO 2024
New project
Under development
Drafting has started.
Will replace IEC 80601-2-78:2019

Abstract

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).

General information

  • Status
     : Under development
    Stage
    : New project approved [10.99]
  • Edition
     : 2
  • Technical Committee :
    ISO/TC 299
  • RSS updates

Life cycle

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

3
Good Health and Well-being
9
Industry, Innovation and Infrastructure

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