Consolidated version
The content of amendment(s) is incorporated into the publication. The track changes mode shows where the publication has been modified by the amendment.
IEC 80601-2-78:2019+AMD1:2024 CSV
IEC 80601-2-78
IEC 80601-2-78:2019
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 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).
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).
CHFÂ 365.-
Consolidated version
The content of amendment(s) is incorporated into the publication. The track changes mode shows where the publication has been modified by the amendment.
DiscoverTechnical committee
TC 62/SC 62D Particular medical equipment, software, and systemsCategory
Safety| Publication type | International Standard |
| Publication date | 2019-07-09 |
| Edition | 1.0 |
| ICS | 11.040.01 |
| Stability date | 2028 |
| ISBN number | 9782832270004 |
| Pages | 156 |
| File size | 4.75 MB |
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