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NEK EN IEC 80601-2-78:2020

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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).

Dokumentinformasjon

  • Standard fra NEK
  • Publisert:
  • Utgave: 2020-04
  • Versjon: 1
  • Varetype: NAT
  • ICS 11.040.01
  • National Committee NEK/NK62

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