Publication details
Publication CODE |
Title |
IEC 80601-2-78:2019 (2019-07) |
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 |
366.00 €
|
156. |
Description
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).
|
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 |
2019-07-09 |
ICS-Code (International Standards Classification) |
11.040.01
|
NBN Status |
New |
|
IEC publication date |
2019-07-09 |
IEC stability date |
2024-12-31 |
IEC file modification date |
2019-07-09 |
IEC last modification date |
2019-07-09 |
|
|