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IEC 80601-2-78-ed.1.1+Amd.1-CSV
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
Translate name
STANDARD published on 12.3.2024
The information about the standard:
Designation standards: IEC 80601-2-78-ed.1.1+Amd.1-CSV
Publication date standards: 12.3.2024
SKU: NS-1168245
The number of pages: 330
Approximate weight : 1021 g (2.25 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 80601-2-78-ed.1.1+Amd.1-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). LIEC 80601-2-78:2019+AMD1:2024 CSV sapplique aux exigences generales pour la SECURITE DE BASE et les PERFORMANCES ESSENTIELLES des ROBOTS MEDICAUX avec interaction physique avec un PATIENT souffrant d’une DEFICIENCE de maniere a permettre ou a effectuer une REEDUCATION, une EVALUATION, une COMPENSATION ou une ATTENUATION associee aux FONCTIONS LIEES AU MOUVEMENT DU PATIENT, comme cela est prevu par le FABRICANT. LIEC 80601-2-78:2019 ne sapplique pas aux: - protheses de membres externes (utiliser lISO 22523), - fauteuils roulants electriques (utiliser lISO 7176 (toutes les parties)), - appareils dimagerie de diagnostic (par exemple, imagerie par resonance magnetique, utiliser lIEC 60601-2-33), et - ROBOTS dassistance a la personne (utiliser lISO 13482).
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