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
Standard number: | IEC 80601-2-78:2019+AMD1:2024 CSV |
Released: | 2024-03-12 |
Language: | English/French - Bilingual |
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).