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Abstract Preview

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

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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