Abstract

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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
     : Published
    Publication date
     : 2019-07
  • Edition
     : 1
    Number of pages
     : 144
  • Technical Committee
     : ISO/TC 299 Robotics
  • ICS
     :
    11.040.01 Medical equipment in general

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Sustainable Development Goals

This standard contributes to the following Sustainable Development Goals

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

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