IEC 80601-2-78:2019+AMD1:2024 CSV
Current
The latest, up-to-date edition.
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Hardcopy , PDF
English - French
12-03-2024
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).
| Committee |
TC 62/SC 62D
|
| DocumentType |
Standard
|
| Pages |
330
|
| PublisherName |
International Electrotechnical Committee
|
| Status |
Current
|
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