Draft
International Standard
IEC/DIS 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/DIS 80601-2-78
Edition 2
© ISO 2026
Draft International Standard
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Under development
This Draft International Standard is in the enquiry phase with ISO members.
Will replace IEC 80601-2-78:2019

IEC/DIS 80601-2-78

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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

    You can help develop this draft international standard by contacting your national member

    Stage
    : DIS ballot initiated: 12 weeks [40.20]
  • Edition
     : 2
    Number of pages
     : 88
  • Technical Committee :
    ISO/TC 299
    ICS :
    11.040.60 
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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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