IEC 80601-2-78:2019+AMD1:2024 CSV
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Appareils électromédicaux - Partie 2-78: Exigences particulières pour la sécurité de base et les performances essentielles des robots médicaux dédiés à la rééducation, l’évaluation, la compensation ou l'atténuation
| Označení normy: | IEC 80601-2-78:2019+AMD1:2024 CSV |
| Vydáno: | 2024-03-12 |
| Edice: | 1.1 |
| ICS: | 11.040.01 |
IEC 80601-2-78:2019+AMD1:2024 CSV
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).