DS/EN IEC 80601-2-77/A1
Medical electrical equipment – Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
| Organization: | DS |
| Publication Date: | 3 January 2024 |
| Status: | active |
| Page Count: | 18 |
| ICS Code (Surgical instruments and materials): | 11.040.30 |
| ICS Code (Medical equipment in general): | 11.040.01 |
scope:
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.
Document History
