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sklademVydáno: 2024-03-12
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
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| Označení normy: | IEC 80601-2-78:2019+AMD1:2024 CSV |
| Vydáno: | 2024-03-12 |
| Jazyk: | Anglicky/Francouzsky |
DESCRIPTION
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).