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IEC 80601-2-78-ed.1.0
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 9.7.2019
The information about the standard:
Designation standards: IEC 80601-2-78-ed.1.0
Publication date standards: 9.7.2019
SKU: NS-953669
The number of pages: 156
Approximate weight : 499 g (1.10 lbs)
Country: International technical standard
Category: Technical standards IEC
The category - similar standards:
Annotation of standard text IEC 80601-2-78-ed.1.0 :
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 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. IEC 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).
These changes apply to this standard:
IEC 80601-2-78-ed.1.0/Amd.1
Change
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Amendment 1 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
(Amendement 1 - Appareils electromedicaux - Partie 2-78: Exigences particulieres pour la securite de base et les performances essentielles des robots medicaux dedies a la reeducation, l’evaluation, la compensation ou l´attenuation)
Change published on 12.3.2024
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