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IEC 80601-2-78 Consolidated version

IEC 80601-2-78:2019+AMD1:2024 CSV
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
IEC 80601-2-78:2019+AMD1:2024 CSV 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).
CONSOLIDATED VERSION
English/French
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Technical committee

TC 62/SC 62D Particular medical equipment, software, and systems

Category

Safety
Publication typeInternational Standard
Publication date2024-03-12
Edition1.1
ICS

11.040.01

Stability date2028
ISBN number9782832285220
Pages330
File size5.52 MB
EditionDatePublicationEditionStatus
  • Ensure healthy lives and promote well-being for all

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