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IEC 80601-2-78:2019+AMD1:2024 Consolidated
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
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Summary
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).
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).
Technical characteristics
| Publisher | International Electrotechnical Commission (IEC) |
| Publication Date | 03/12/2024 |
| Release Date | 03/12/2024 |
| Edition | 1.1 |
| Page Count | 330 |
| Themes | Safety |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
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