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Standard

IEC 80601-2-78:2019

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Zusammenfassung

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).

Produktspezifikationen

  • Standard von IEC
  • Ausgabedatum:
  • Edition: 1
  • Dokumenttyp: IS
  • Seiten
  • Herausgeber: IEC
  • Lieferant: IEC
  • ICS: 11.040.01
  • Internationales Komitee: ISO/TC 299

Produktbeziehungen

  • Joint work item: IEC, 0