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
Note: a more recent version of this publication exists
IEC 80601-2-78:2019+AMD1:2024 CSV
Abstract
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).
Additional information
Publication type | International Standard |
---|---|
Publication date | 2019-07-09 |
Edition | 1.0 |
Available language(s) | English/French |
TC/SC | TC 62/SC 62D - Particular medical equipment, software, and systemsrss |
ICS | 11.040.01 - Medical equipment in general |
Stability date | 2028 |
Pages | 156 |
File size | 4979 KB |
The following test report forms are related:
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