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
OVERVIEW
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).
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2024 |
| No. of Pages | 330 |
| ICS Classification | 11.040.01 Medical equipment in general |
| Committee | TC 62/SC 62D |
| Available for Purchase | For sale in Singapore only |
| Adoption | IEC : 0 |