Publication details
| Publication CODE |
Title |
| IEC 80601-2-78:2019+AMD1:2024 CSV (2024-03) |
MEDICAL ELECTRICAL EQUIPMENT - PART 2-78: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL ROBOTS FOR REHABILITATION, ASSESSMENT, COMPENSATION OR ALLEVIATION |
| |
| Price Excl. VAT |
Total number of pages, tables and drawings |
|
848.00 €
|
330. |
Description
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).
|
| Class |
C990
(IEC PUBLICATIONS IEC PUBLICATIONS)
|
Status
| Status |
IEC PUBLICATION |
| Situation |
Currently active
|
|
Origin
| Committee |
TC 62/SC 62D
ELECTROMEDICAL EQUIPMENT
|
| Responsible |
De heer VAN HECKE Luk
|
Approval
| BEC Approval |
2024-03-12 |
| ICS-Code (International Standards Classification) |
11.040.01
|
| NBN Status |
New |
|
| IEC publication date |
2024-03-12 |
| IEC stability date |
2028-12-31 |
| IEC file modification date |
2024-03-12 |
| IEC last modification date |
2024-03-12 |
|
|
