UNE EN IEC 80601-2-77:2021
Medical Electrical Equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (Endorsed by Asociación Española de Normalización in November of 2021.)
Equipos electromédicos. Parte 2-77: Requisitos particulares para la seguridad básica y funcionamiento esencial de los equipos quirúrgicos asistidos robóticamente (Ratificada por la Asociación Española de Normalización en noviembre de 2021.)
| Označení normy: | UNE EN IEC 80601-2-77:2021 |
| Počet stran: | 62 |
| Vydáno: | 2021-11-01 |
| Status: | Norma |
UNE EN IEC 80601-2-77:2021
Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEM (RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEM together with their INTERFACE CONDITIONS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS, as relevant. This particular standard is not applied to X-ray-based image-guided radiotherapy equipment (use IEC 60601-2-68:20XX). HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this standard are not covered by specific requirements in this standard except in subclauses 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard.
