IEC 80601-2-78:2019
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 |
| Released: | 2019-07-09 |
| Language: | English/French - Bilingual |
IEC 80601-2-78:2019
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).